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How to Write a Research Proposal | Examples & Templates

Published on October 12, 2022 by Shona McCombes and Tegan George. Revised on November 21, 2023.

A research proposal describes what you will investigate, why it’s important, and how you will conduct your research.

The format of a research proposal varies between fields, but most proposals will contain at least these elements:

Introduction

Literature review.

• Research design

Reference list

While the sections may vary, the overall objective is always the same. A research proposal serves as a blueprint and guide for your research plan, helping you get organized and feel confident in the path forward you choose to take.

Table of contents

Research proposal purpose, research proposal examples, research design and methods, contribution to knowledge, research schedule, other interesting articles, frequently asked questions about research proposals.

Academics often have to write research proposals to get funding for their projects. As a student, you might have to write a research proposal as part of a grad school application , or prior to starting your thesis or dissertation .

In addition to helping you figure out what your research can look like, a proposal can also serve to demonstrate why your project is worth pursuing to a funder, educational institution, or supervisor.

Research proposal length

The length of a research proposal can vary quite a bit. A bachelor’s or master’s thesis proposal can be just a few pages, while proposals for PhD dissertations or research funding are usually much longer and more detailed. Your supervisor can help you determine the best length for your work.

One trick to get started is to think of your proposal’s structure as a shorter version of your thesis or dissertation , only without the results , conclusion and discussion sections.

Download our research proposal template

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Writing a research proposal can be quite challenging, but a good starting point could be to look at some examples. We’ve included a few for you below.

• Example research proposal #1: “A Conceptual Framework for Scheduling Constraint Management”
• Example research proposal #2: “Medical Students as Mediators of Change in Tobacco Use”

Like your dissertation or thesis, the proposal will usually have a title page that includes:

• The proposed title of your project
• Your supervisor’s name
• Your institution and department

The first part of your proposal is the initial pitch for your project. Make sure it succinctly explains what you want to do and why.

Your introduction should:

• Introduce your topic
• Give necessary background and context
• Outline your  problem statement  and research questions

To guide your introduction , include information about:

• Who could have an interest in the topic (e.g., scientists, policymakers)
• How much is already known about the topic
• What is missing from this current knowledge
• What new insights your research will contribute
• Why you believe this research is worth doing

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As you get started, it’s important to demonstrate that you’re familiar with the most important research on your topic. A strong literature review  shows your reader that your project has a solid foundation in existing knowledge or theory. It also shows that you’re not simply repeating what other people have already done or said, but rather using existing research as a jumping-off point for your own.

In this section, share exactly how your project will contribute to ongoing conversations in the field by:

• Comparing and contrasting the main theories, methods, and debates
• Examining the strengths and weaknesses of different approaches
• Explaining how will you build on, challenge, or synthesize prior scholarship

Following the literature review, restate your main  objectives . This brings the focus back to your own project. Next, your research design or methodology section will describe your overall approach, and the practical steps you will take to answer your research questions.

To finish your proposal on a strong note, explore the potential implications of your research for your field. Emphasize again what you aim to contribute and why it matters.

For example, your results might have implications for:

• Improving best practices
• Informing policymaking decisions
• Strengthening a theory or model
• Challenging popular or scientific beliefs
• Creating a basis for future research

Last but not least, your research proposal must include correct citations for every source you have used, compiled in a reference list . To create citations quickly and easily, you can use our free APA citation generator .

Some institutions or funders require a detailed timeline of the project, asking you to forecast what you will do at each stage and how long it may take. While not always required, be sure to check the requirements of your project.

Here’s an example schedule to help you get started. You can also download a template at the button below.

Download our research schedule template

If you are applying for research funding, chances are you will have to include a detailed budget. This shows your estimates of how much each part of your project will cost.

Make sure to check what type of costs the funding body will agree to cover. For each item, include:

• Cost : exactly how much money do you need?
• Justification : why is this cost necessary to complete the research?
• Source : how did you calculate the amount?

To determine your budget, think about:

• Travel costs : do you need to go somewhere to collect your data? How will you get there, and how much time will you need? What will you do there (e.g., interviews, archival research)?
• Materials : do you need access to any tools or technologies?
• Help : do you need to hire any research assistants for the project? What will they do, and how much will you pay them?

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

Methodology

• Sampling methods
• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

Once you’ve decided on your research objectives , you need to explain them in your paper, at the end of your problem statement .

Keep your research objectives clear and concise, and use appropriate verbs to accurately convey the work that you will carry out for each one.

I will compare …

A research aim is a broad statement indicating the general purpose of your research project. It should appear in your introduction at the end of your problem statement , before your research objectives.

Research objectives are more specific than your research aim. They indicate the specific ways you’ll address the overarching aim.

A PhD, which is short for philosophiae doctor (doctor of philosophy in Latin), is the highest university degree that can be obtained. In a PhD, students spend 3–5 years writing a dissertation , which aims to make a significant, original contribution to current knowledge.

A PhD is intended to prepare students for a career as a researcher, whether that be in academia, the public sector, or the private sector.

A master’s is a 1- or 2-year graduate degree that can prepare you for a variety of careers.

All master’s involve graduate-level coursework. Some are research-intensive and intend to prepare students for further study in a PhD; these usually require their students to write a master’s thesis . Others focus on professional training for a specific career.

Critical thinking refers to the ability to evaluate information and to be aware of biases or assumptions, including your own.

Like information literacy , it involves evaluating arguments, identifying and solving problems in an objective and systematic way, and clearly communicating your ideas.

The best way to remember the difference between a research plan and a research proposal is that they have fundamentally different audiences. A research plan helps you, the researcher, organize your thoughts. On the other hand, a dissertation proposal or research proposal aims to convince others (e.g., a supervisor, a funding body, or a dissertation committee) that your research topic is relevant and worthy of being conducted.

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Basic Methods Handbook for Clinical Orthopaedic Research pp 249–254 Cite as

How to Write a Winning Clinical Research Proposal?

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This chapter addresses general approaches towards writing a clinical research proposal. The landscape in research has changed in the last decade and has become more translational in nature. Therefore, research proposals are read and evaluated by scientists from various fields that may not be intricately familiar with specific techniques and technique-related jargon. This chapter is designed to address the need for more translational and reviewer-friendly proposal writing and is built on errors and mistakes commonly seen in research proposals.

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Lattermann, C., Whalen, J.D. (2019). How to Write a Winning Clinical Research Proposal?. In: Musahl, V., et al. Basic Methods Handbook for Clinical Orthopaedic Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-58254-1_27

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Preparation of the Investigator for a Proposal

The research proposal, insights into the reviewer's perspective, conclusions, writing successful research proposals for medical science  .

(Schwinn) Professor of Anesthesiology and Surgery; Associate Professor of Pharmacology/Cancer Biology, Duke University Medical Center; Senior Fellow, Duke Pepper Aging Center.

(DeLong) Associate Professor, Division of Biometry and Medical Informatics, Duke University Medical Center.

(Shafer) Staff Anesthesiologist, Palo Alto VA Health Care System; Associate Professor of Anesthesia, Stanford University.

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Debra A. Schwinn , Elizabeth R. DeLong , Steven L. Shafer; Writing Successful Research Proposals for Medical Science   . Anesthesiology 1998; 88:1660–1666 doi: https://doi.org/10.1097/00000542-199806000-00031

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HIGH-QUALITY research proposals are required to obtain funds for the basic and clinical sciences. In this era of diminishing revenues, the ability to compete successfully for peer-reviewed research money is essential to create and maintain scientific programs. Ideally, the essentials of “grantsmanship” are learned through observation and participation in grant preparation, but the training environment experienced by most physicians typically focuses on clinical skills. Most physicians are never exposed to a research environment and therefore do not learn how to write grants. The result is that many clinical studies, even when designed by skilled clinicians and those that address important clinical questions, often do not compete successfully with proposals written by basic scientists. This creates a perception that clinical studies are not favorably viewed by research review committees. The opposite is probably closer to the truth; research review committees are very keen to fund excellent clinical research. Although greater numbers of researchers with Ph.D. degrees have applied for National Institutes of Health (NIH) grants compared with researchers with M.D. degrees over the last 10 yr, funding rates (percent applications funded) have remained approximately the same for these investigators ( Figure 1 ; 1995 success rates: all degrees, 6,759 [26.8%]; M.D. - Ph.D., 370 [23.1%]; M.D., 1,518 [28.1%]; Ph.D., 4,746 [26.8%]; other degree, 125 [23.1%]).[section]

Figure 1. Overall success rates for NIH funding of scientific applications, 1986 - 1995. No difference in funding rate is observed between applicants holding M.D. versus Ph.D. degrees. As the success rate for first-time applications was 11.3% in 1993, it is apparent that resubmission of a revised application significantly increases the overall chance of having research proposal ultimately funded.[section]

Capable medical researchers ultimately write research proposals for funding by the NIH. Standards of excellence for NIH grants are high (only the top [almost equal to] 20% of grants are funded). Research questions posed must be hypothesis driven; the investigator must be qualified to perform the study; and preliminary evidence should be presented demonstrating that the research is feasible and will answer the questions posed. The goal of this article is to review important elements of successful research proposals, with emphasis on funding sources available to the anesthesiology community. Two important anesthesia-specific organizations exist to support anesthesia research - The Foundation for Anesthesia Education and Research (FAER, an organization under the auspices of the American Society of Anesthesiologists) and the International Anesthesiology Research Society (IARS).

Successful applications for research support from FAER and IARS have many of the characteristics of grants funded by the NIH and other peer-reviewed funding sources. These characteristics include (1) a highly qualified investigator(s);(2) for junior investigators, a mentor with a successful track record in scientific investigation, peer-reviewed funding, and mentorship of fellows and faculty;(3) a supportive academic environment; and (4) a scientifically sound proposal. Each of these characteristics is discussed in the subsequent sections.

Training of the Investigator

One of the most important components of a successful research proposal is a well-trained investigator. Training in clinical anesthesia is not training in research methodology or scientific thinking; it does not prepare an individual for a career in investigation. Although obvious for basic science research, clinical research also requires commitment of a minimum of 1 yr of dedicated training with a good mentor, and more typically 2 - 3 yr in the field of the proposed research. The applicant also needs to demonstrate commitment to a career in investigation. Several years of scientific training is the first demonstration of such commitment. Research proposals must document institutional support for nonclinical time, and the investigator must provide evidence that this time has been used wisely and will continue to be dedicated to the proposed research.

The research proposal must document a track record of productivity by the investigator. This expectation increases as the training and career of the investigator progresses. Fellowship awards do not have an expectation of prior research training, so publications from prior research are not expected. At the fellowship level, outstanding letters of recommendation, undergraduate and medical school performance, and related accomplishments are most important. Because previous training is not required of the fellowship applicant, prior success of the mentor (publications and track record with previous trainees) weighs heavily in the fellowship review. For junior faculty, peer-reviewed publications are expected from the fellowship period. Young Investigator Annoucements (from FAER) and several new IARS awards require several years as a successful junior faculty member, so expectations of demonstrated research success are further increased. The investigator must demonstrate (1) rigorous training, (2) commitment to research, (3) an appropriate career path, and (4) a track record of productive work. None of these are trivial issues, and none can be easily accomplished without making a commitment to research early in the academic career.

The quality of the mentor is another important aspect of awards granted to fellows and junior faculty. Identification of a mentor is explicitly required for FAER and certain junior level NIH grant applications. First and foremost, the mentor must be a successful investigator. Criteria for this include a track record of publication in the area of the proposed research, continued peer-reviewed funding, and a history of successfully training young investigators. Although mentorship is not considered heavily in more senior grant applications, input from a more experienced investigator often remains beneficial throughout one's career (as we can personally attest to). In addition to the mentor, high-quality coinvestigators, collaborators, and consultants also play important roles in strengthening a research proposal.

Environment

Good research is best accomplished in a supportive, cooperative environment. Because of the changing climate of clinical medicine, researchers (both clinical and basic science) face increasing pressure to minimize research time. It is not possible to become a successful investigator in one's spare time. Documentation of adequate nonclinical time for research (not for committee meetings or other unrelated tasks) is essential. Receiving funding at a junior level often enables the department to match funds or to guarantee nonclinical time to the budding investigator. In general, the more non-clinical time available to an investigator, the more competitive the application.

Other important elements of the environment include people, space, and institutional resources. People include mentors, consultants who can help with specific methodologies, statistical support, helpful colleagues, experienced technicians, a clinical research team, and a dedicated chairperson. There must be adequate space for performing the proposed studies, office space for research personnel, and storage space for equipment and supplies. Institutional resources include related departmental and interdepartmental seminar series, a critical mass of investigators in a related area, instrument development and repair shops, and necessary laboratory space and common facilities.

Criteria for a sound research proposal are the same whether the proposal is submitted to NIH, FAER, IARS, or other funding sources. In crafting a proposal, it is essential to consider the perspective of the reviewer; therefore, items of interest to the reviewer are listed after general definition of the grant proposal.

Review committees receive dozens of grants. NIH study sections may review as many as 150 proposals during one session. Typically, only two or three reviewers are assigned to read each grant in detail, but everyone is expected to read each abstract. Hence, the abstract is often one of the most important parts of the research proposal. The abstract should address the significance of the question and the overall topic, state the hypothesis, and point out key preliminary data. Additionally, the abstract should provide a synopsis of methodologies planned. In the end, the reviewer must be convinced that the applicant is uniquely (or ideally) suited to undertake this important study by the end of this concise paragraph.

Body of the Grant

Specific Aims. The specific aims section is critically important in a scientific proposal. It is here that the investigator crystallizes the overall goal of the research and states specific hypotheses.

Beginning with the specific aims, the proposal must be well written and logically organized. A poorly organized grant application is difficult to review, even if the science is otherwise excellent. Typically, the specific aims begin with a short introduction (one paragraph), followed by a formally stated hypothesis. The hypothesis must be answerable by the research methods proposed. Generally, two or three specific aims are outlined with subheadings where appropriate. Organization of the specific aims is often temporal, starting with a proposed mechanism or the first set of studies in a clinical project. In general, the specific aims section should be no longer than one page.

Background and Significance. The background section provides an opportunity to bring reviewers up to date on current research in the area of the proposal. This section should summarize succinctly studies from the literature and related work published by the investigator. The most crucial aspect of the background is to build a case for significance of the proposed research regarding the ultimate clinical application or mechanistic understanding. Ideally, the background section should demonstrate that the current proposal is a logical extension of previous studies in the field and will provide new information and novel insights. In general, the background section should be about one fourth of the length of the grant proposal.

Preliminary Data. Preliminary data provide the opportunity for the investigator to demonstrate his or her ability to perform the proposed research. The goal in presenting preliminary data is to convince the reviewer that the investigator is capable of performing the proposed studies and that the mechanisms proposed are plausible. Good preliminary data support novel (or even unlikely) hypotheses. Each experimental method proposed should be accompanied by preliminary data demonstrating facility and expertise with related preparations. For example, if the investigator proposes using a specific electrophysiologic technique to study an ion channel, evidence demonstrating that this technique has been used by the investigator with other ion channels and a Figure showingresults from pilot experiments on the channel of interest would suffice. In clinical studies, demonstration of a working investigative team and the ability to enroll a given number of patients per week is helpful. Figures or tables help to convey the message in a succinct manner. They also conserve space in the proposal and create a more impressive effect. Although it is best if the applicant has generated his or her own preliminary data, for training awards, preliminary data from the mentor's laboratory is entirely appropriate. An effective way to organize preliminary data is to present it in the same order as the specific aims (e.g., C.1 preliminary data corresponds to A.1 specific aims, C.2 preliminary data corresponds to A.2 specific aims, etc.). Presentation of preliminary data usually takes about one fourth to one third of the length of the grant application.

Methods. The methods are the guts of the research proposal. Unfortunately, many investigators run out of steam by the time they reach the methods, leaving reviewers unconvinced by the proposed methodology. Ideally, the model being investigated should be broken down into simple, logical components, each accompanied by a description of specific experiments/interventions to be performed. The investigator should assume that at least one reviewer is an expert in each method presented. Therefore, enough detail should be provided to convince an expert that the experiment or technique is being performed properly. Methods presented as a list of recipes, requiring the reviewer to guess which method applies to each study, are recipes for disaster. Individual experimental techniques should be state of the art. In addition, approaching a problem from several angles is often helpful. “Lingo” of the field should be avoided; it is very annoying to reviewers to have to look up unexplained abbreviations or to have models alluded to rather than described. For training grants, methods should involve techniques currently being performed in the laboratory of the mentor. An effective way to organize the methods section is to follow the same order as the preliminary data and specific aims sections (e.g., D.1 methods corresponds to C.1 preliminary data and A.1 specific aims, etc.).

The methods sections should include a description of the design, conduct, and analysis of each study being proposed. Common errors in design include lack of specification of primary outcome, lack of randomization or blinding in clinical trials, inadequate justification of sample size, failure to adjust the total study number for expected dropouts/failed experiments or patient refusal, and use of single drug doses or concentrations rather than development of dose - response or concentration - response relations. Common errors in conducting research include lack of confirmation of drug concentrations, inadequate reproducibility of final results, lack of standardization of procedures, inadequate follow-up, incomplete data recording, and overall lack of organization.

Inadequate or inappropriate statistical methods can be a major weakness of a grant proposal. Many investigators feel confident with all aspects of their methods except the statistical section. Because statistical issues underlie the design and analysis strategy for every study, the input of a biostatistician is essential in planning the research and writing the grant application. Statistical considerations include specification of the primary end points that drive power calculations. Common statistical errors in research proposals include lack of sample size/power calculations, treating continuous variables as dichotomous, repeated t tests when a more comprehensive modeling approach should be taken, application of statistical tests that assume normality without verifying assumptions, failure to consider covariate effects, and failure to distinguish between interindividual and intraindividual variability. The investigator should be familiar with the concept of statistical power and be prepared to estimate some of the quantities needed to formulate an alternative hypothesis appropriately. The statistical analysis should be clearly outlined with specific methodology directed toward the hypotheses of the study. A statistical reviewer is unlikely to be convinced by a statement that “appropriate statistical methodology will be used” or by a barrage of nonspecific statistical jargon. At least one full paragraph (and sometimes an entire page) of the research proposal should be devoted to statistical analysis. Often several smaller statistics sections are appropriately included after each method is presented.

Even the best methods have potential problems and weaknesses. It is critical that the methods section discuss potential problems that may be encountered during the study and state how the investigator proposes to deal with these problems creatively. Reviewers tend to be impressed when the investigator presents potential problems that never occurred to them, because it suggests that the investigator is an expert in this area of research. A time line and organizational plan (who will be responsible for what) should also be included in the methods section so the reviewers can determine whether the investigator is being realistic in his or her approach. The methods section is typically one third to one half of the length of the entire grant proposal.

Introduction to Revised Application. Because so few grant applications are funded on their first submission (11.5% in 1993), the new investigator should not be unduly alarmed if his or her application is not funded. When a grant application has been unsuccessful, an investigator should revise the application and reapply, even if the original score was “noncompetitive”(meaning the grant was in the lower 50% of applications). Often the reviewers suggest key changes that will improve the application significantly. When submitting a revised application, an introduction (placed before the specific aims section) is used to discuss how criticisms of the original grant have been addressed in the revised proposal. Because the reviewer's comments are intended to be helpful, it is important to address each concern carefully in the revised proposal (changed text should be highlighted in the revised application by italic, bold, or identifying lines in the margin), with changes outlined in the introduction section. Angry responses to reviewers do not facilitate funding of the revised application. Remember that reviewers usually have a copy of the prior review, and they expect corrections or, when appropriate, an explanation of why you have chosen not to incorporate some suggestions from a prior review. Time taken to revise an application is well spent; as Figure 1 demonstrates, investigators who persist in revising and resubmitting their applications have an increased chance ([almost equal to] 20% with no previous NIH support, [almost equal to] 35% if previously funded) of ultimately being funded.[section]

In writing a research grant, it is helpful to consider the reviewer's perspective. Key features considered by reviewers include significance, approach, and feasibility. It is wise for the investigator to reread his or her application before submission with these features in mind. The NIH recently has published two documents on-line that discuss review criteria; examination of these documents before submission of a research proposal may prove helpful. These include the Report of the Committee on Rating Grant Applications[double vertical bar] and Review Criteria for Rating Unsolicited Research Grants.#

Significance

First and foremost, is the investigator asking an important question? There are two general ways research studies can be significant. The first is to demonstrate clinical significance. The litmus test for clinical significance is whether the proposed research will improve patient care. The second is elucidation of fundamental mechanisms underlying disease or biologic processes. The ideal research question succeeds in being significant in both areas.

The reviewer assesses whether the research plan can support or refute the stated hypothesis. In addition, the reviewer assesses whether the methodologies used provide adequate or, better yet, elegant approaches to the problem. Recently, the NIH has mandated an increasing emphasis on innovation in research. [1] **

Review committees generally are composed of individuals with expertise in many scientific areas. Additionally, study sections often retain outside reviewers with expertise in the proposed research area. The investigator should assume that his or her methods will be critiqued by at least one expert. Therefore, the investigator should not propose a method that would strike the world's expert in the field as being simplistic, inappropriate, or nonsensical, because the world's expert just might be one of the reviewers. Conversely, some reviewers do not have expertise in the proposed area of research. To ensure that the nonexpert is convinced of the validity and importance of proposed methodologies, the overall proposal should be written with a logical flow of ideas that build from basic to sophisticated concepts. Beginning each portion of the methods section with a short introduction for the nonexpert, followed by a more detailed description of the proposed methods, is an effective strategy to address the needs of both expert and nonexpert reviewers.

Feasibility

The investigator must convince reviewers that the chosen approach is feasible. Preliminary data provide the best demonstration of feasibility. Feasibility is often demonstrated by a track record of publications or peer-reviewed grant support for the applicant or mentor using the proposed experimental approach. Feasibility also can be demonstrated by appropriate statistical analysis of the proposal. For example, a power analysis and corresponding data on the number of patients with the required characteristics at the investigator's institution helps convince reviewers that a clinical study is feasible.

Anesthesiology Funding Sources

Funding for research performed by anesthesiologists is available from many sources. Because the discipline of anesthesiology overlaps many other fields, anesthesiologists have the opportunity to apply for research funds from agencies as diverse as the American Academy of Pediatrics, American Cancer Society, American Heart Association (national and local), American Thoracic Society, American Society for Regional Anesthesiology, critical care societies, Department of Veterans Affairs, National Science Foundation, Shriners, Society for Cardiovascular Anesthesiology, Society for Obstetrics and Perinatology, National Aeronautics and Space Aviation, NIH, and many other private foundations. Grants from FAER and IARS are available specifically to the anesthesiology community.

It is important that anesthesiologists continue to apply for NIH grants. For fiscal year 1996, the NIH awarded 149 research grants (including career development grants, R29, R01, and program project grants) to departments of anesthesiology, totaling $21 million in direct costs ([almost equal to]$31 million in total costs). Because of the diversity of research projects in anesthesiology, these grants were awarded by 14 different institutes, centers, and divisions within the NIH. In analyzing data for three recent review sessions (June 1996, October 1996, and February 1997) from the surgery, anesthesiology, and trauma study section, 26% of anesthesiology applications scored in the top 20th percentile, and 31% scored in the top 25th percentile; clearly no bias exists against anesthesiology in this predominantly surgical study section, at least in this limited sample (Alison Cole, anesthesiology representative for the National Institute of General Medicine Science at the NIH, personal communication, December, 1997). Table 1  

Table 1. Number of Recipients of NIH Research Project Annoucements  

A brief list of funding opportunities available to anesthesiologists early in their career is shown in Table 2 . Several sites are available on the World Wide Web ( Table 3 ) to facilitate access to grant/training resources for anesthesiologists. We have created an additional website ( http://pkpd.icon.palo-alto.med.va.gov/grants/grants.htm ), which provides access to more comprehensive lists of funding agencies and direct links to funding sources. This website also contains example grants designed to illustrate the grant writing principles discussed in this article.

Table 2. Potential Funding Sources  

Table 3. Grant/Training Resources on the WWW  

Successful grant applications require a well-trained investigator who carefully outlines a hypothesis-driven research proposal. Unique to FAER and IARS research committees is that the reviewers are mostly investigators and practicing anesthesiologists. These reviewers fully appreciate the importance of clinical research and enthusiastically support high-quality clinical studies. Although descriptive clinical studies are interesting to practicing clinicians, from a scientific perspective, clinical research must be driven by testable hypotheses. Without a testable hypothesis, clinical research cannot pass the test of adequate significance required for funding.

It is our hope that by demystifying the grant writing and review process that more anesthesiologists will be encouraged to submit proposals for research funding. As part of this effort, we strongly encourage residents and fellows interested in research careers to obtain adequate research training and to apply for appropriate fellowship/junior faculty awards early in their careers.

[section] NIH Extramural Data and Trends, Fiscal Years 1986 - 1995. Bethesda, Office of Reports and Analysis (component of the Office of Extramural Research), National Institutes of Health. (Published on-line and periodically updated. http://www.nih.gov/grants/award/award.htm ).

[double vertical bar] Report of the Committee on Rating Grant Applications. Revised 5/17/96. Bethesda, National Institutes of Health. (Published on-line. http://www.nih.gov/grants/peer/rga.pdf ).

# Review Criteria for Rating Unsolicited Research Grants. NIH Guide, Vol. 26, No. 22, 6/27/97. Bethesda, National Institutes of Health. (Published on-line. http://www.nih.gov/grants/guide/1997/97.06.27/notice-review-criter9.html ).

** Brown KS: A winning strategy for grant application: Focus on impact. The Scientist 1997; April 8:13–4

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87Chapter 4 Writing your research proposal

• Published: November 2011
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In many ways it’s a reflection of yourself as a researcher and an insight into your proposed work. A poorly written proposal has the ability to wreck a project and embarrass the researcher before it has even begun. Similarly, a well-constructed proposal bodes well for the success of the project and displays the researcher in a good light amongst their peers and supervisors. The research proposal identifies: • What the topic is, both in terms of background and the individual area of interest. • What you plan to accomplish and why it needs doing. • What in particular you are trying to find out, i.e. the research question. • How you will get the answer to your question, i.e. your methodology. • What others will learn from it and why it is worth learning. • How long it will take. • How much money it will cost. Through your research proposal you are attempting to convince potential supporters that your project is worth doing, you are scientifically competent to run it, and are in possession of the necessary management skills to ensure its completion. The proposal concisely describes the key elements of the study process, although in sufficient depth to permit evaluation. It is a stand-alone document that must contain evidence of an answerable question, demonstrate your grasp of the literature, and also clearly show that your methodology is sound. A research time-table is required to demonstrate a realistic appreciation of how the study will progress through time. The research proposal serves many purposes to many different parties. Amongst these purposes, some of the key ones are: • Acting as a route map and timetable for all involved in your project. • Giving a clear overview of your planned work to ensure favourable decision at ethical review. • Gaining funding to carry out your proposed study. • Securing a place to undertake a higher scientific degree. • Being an opportunity to ‘blow your own trumpet’ on paper. Although there are several bodies who will be obliged to see your proposal, there is a reasonable chance it will end up being wider read than this, so a coherent piece of work will reflect well on you.

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Chapter 32:  Writing a Research Proposal

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Introduction.

• COMPONENTS OF THE RESEARCH PLAN
• PLAN FOR ADMINISTRATIVE SUPPORT
• PRESENTATION OF THE PROPOSAL
• Full Chapter
• Supplementary Content

The initial stages of the research process include development of the research question and delineation of methods of data collection. The success of the project depends on how well these elements have been developed and defined in advance, so that the proper resources are gathered and methods proceed with reliability and validity. The plan that describes all these preparatory elements is the research proposal . The proposal describes the purpose of the study, the importance of the research question, the research protocol and justifies the feasibility of the project.

The proposal can serve several purposes. First, it represents the synthesis of the researcher's critical thinking and the scientific literature to ensure that the research question is refined enough to be studied, that the assumptions and theoretical rationale on which the study is based are logical and that the method is appropriate for answering the question. Second, the well prepared proposal may constitute the body of a grant application when external funding is required. Third, it is part of an application for review by peer or administrative committees. This is the document that will be carefully scrutinized by the Institutional Review Board (IRB) (see Chapter 3 ). Fourth, the proposal enhances communication among colleagues who may be co-investigators and with consultants whose advice may be needed. Finally, the careful, detailed account of the study procedures serves as a guide throughout the data collection phase to ensure that the researchers follow the outlined rules of conduct. The research proposal, therefore, is an indispensable instrument in initiating and implementing a project.

When proposals are written as part of a grant application for funding from foundations or government agencies, the researcher must obtain the guidelines of the agency to which the proposal will be submitted. Generally, requirements and components of a proposal will be the same for grant applications as they are for academic and clinical institutions; however, to write a successful grant application, the researcher must understand the interests of the funding agency, the extent of available funds, the deadlines for submitting proposals, and the proper format of the application. ∗

The purpose of this chapter is to discuss the process of developing and writing a research proposal. The exact format of the proposal will depend on the requirements or instructions of the individuals, clinics, faculty or agencies that will review the project. The order of presentation of material may vary, as may the extent of the information required. The following guidelines are meant to reflect the most common elements of a proposal. A research proposal has two basic parts, as shown in Table 32.1 . The first part provides details of the research plan, and the other describes the administrative and personnel support required to carry out the project.

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Research Development and Proposal Writing

The Division of Cardiovascular Medicine Strategic Research Development team actively supports our clinical fellows, postdoctoral fellows, and junior faculty in project development & proposal writing.

Priorities include:

• Diversity Supplements (all career stages)
• Fellowships (clinical fellows and postdocs)
• First major research grant (junior faculty)
• Select large program projects (all career stages*)

Services Include:

• Identifying funding opportunities
• Editing and critically evaluating proposals
• Interpreting sponsor requirements and providing strategic advice
• Drafting specific administrative sections of the application
• Assisting with pre-award budgeting, progress reports, and other supports
• Coordinating completion of proposals, subcontracts, and select large collaborative projects
• Providing educational resources, workshops, and one-on-one consultations

Our model of 1:1 grant support is designed to enable the PI to  focus on the science:

• Recurring meetings to discuss progress, review drafts, and strategize
• Project management, including checklists and timelines
• Shared collaborative folders containing comprehensive educational resources and templates
• Mock reviews scheduled as needed

Individuals submitting fellowships and career development awards are highly encouraged to register for and complete the Grant Writing Academy's Proposal Bootcamp as they prepare their submissions. Sign up here: https://grantwriting.stanford.edu/online-proposal-bootcamp/

Subcontracts may receive limited project management support (coordinating with RMG, a first draft of the budget justification based on the budget, and help gathering required documents).

*Larger grants (i.e. program project grants) are a very time-sensitive endeavor. Support for these will continue to be on a very limited basis and must be approved by division leadership.

Support is only available for proposals in which the PI is submitting through the Division of Cardiovascular Medicine.

Deadline to request support:

**Any desired changes to appointments (i.e., Instructor) must be discussed with and approved by your primary mentor and Dr. Eldrin Lewis seven months before the new appointment would begin OR two months before the grant is due – whichever is earlier. The faculty mentor is financially responsible for any backstop if a career development award is not funded or does not fully cover the Instructor salary.

The Strategic Research Development Team has limited bandwidth, especially around high-volume (NIH and AHA) deadlines, and we cannot accommodate last-minute requests. Exceptions to these deadlines should be emailed to Liz Seckel and will be considered on a case-by-case basis for quick turnaround RFAs with a strong likelihood of being funded.

The division reserves the right to assess support requests based on the workload of the team. 

Liz Seckel, MA

Director, Strategic Research Development

[email protected]

A former neuroscience researcher, Liz has helped raise tens of millions of dollars from public and private funding entities to advance health equity and social justice initiatives, and received several awards and distinctions both for her scientific work as well as her commitment to philanthropy. Liz provides individualized grantsmanship advice, coaching, and assistance to all tiers of trainees and faculty in CV Med.

Brandi Stephens, PhD

Research Development Specialist

[email protected]

Dr. Brandi Stephens is a cardiovascular physiologist by training with expertise in diversity and health equity research.   She combines her love for science and passion for grant writing to lead CV Med fellows, postdoctoral scholars, and junior faculty in submitting competitive fellowships and career development awards. Roles include identifying funding opportunities, meeting 1:1 to navigate the grant writing process, and providing critical feedback.

Jennifer Nguyen

Grants Specialist

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Jennifer joined CV Med’s Strategic Research Development Team to manage the submission of grant applications and post-award progress reports. She also leads pre-award budgeting and facilitates other supports. Jenn is an accomplished research administrator completing her MS in Health Care Administration at Cal State East Bay.

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Clinical Research Proposal

In the time when the sea was the avenue through which a nation can conquer the world, Britain believed that a strong naval fleet of almost 2,000 men could make a dent out of Spain’s stronghold in America. After surviving the storms and long days at sea, the people did not expect that they would fall prey to a silent killer amongst them. Sailors had been dying from the most common maritime disease that had claimed the lives of countless others—scurvy. It was only later learned that the disease could be cured with citrus fruits, thanks to the physician James Lind. Years after the treatment for scurvy was available, Britain became a naval superpower, and the English language started to be introduced to the rest of the world. Lind’s observation was the first of many clinical research that changed the world.

7+ Clinical Research Proposal Templates and Samples

However revolutionary, there are downsides to fresh fruits as the go-to cure for the disease. Citrus fruits generally do not last long, especially then when there was no refrigerator nor electricity. The extract contains a volatile compound in its natural form. Heat and long periods of storage destroy the therapeutic activity of the substance, and the compound itself. It was much later that vitamin C was synthetically produced as tablets and capsules. Before a drug reaches the patients, it undergoes a series of tests and clinical trials that ensure that the drug is safe and significantly effective. Clinical research deals with treatments and services for the benefit of society. Clinical researchers are working on several treatment and prevention options to improve and advance medicine and human health. Their revolutionary ideas start with a research proposal for succeeding tests and validations.

1. Research Proposal Template

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Clinical research covers studies that deal with the improvement of health products and services. Each study proposes news or reviews the effect of the present method or product aimed to better the health quality of people. For the research to proceed to the testing for efficacy and safety for human consumption, researchers first have to convince a board or committee concerned that the study is worth pursuing. The research proposal should sway the respective authority to approve and support the activity. It should show that you are competent and capable of conducting the desired research undertaking. To help you in preparing for your proposal, you can download the sample  Research Proposal Template  shown above.

2. Research Project Proposal Template

A research proposal is a declaration of intent to pursue a research direction, pending the approval and endorsement of proper channels. It is also a ticket for a financial grant by government agencies and private institutions. The document introduces the study, its objectives, and its significance to the scientific body and society. It also includes an overview of the research methods and techniques that the researchers plan to perform, the project timeline , as well as a breakdown of possible expenses that will be incurred during the conduct of the study. You don’t start from scratch when you get a copy of the Research Project Proposal Template  we’ve included above.

3. Brief Research Proposal Template

The document is a summary of the study. The problem statement and the methodology used for the research must be clear. The researchers should have a general idea of how their study will be conducted. This will be evident in the methods proposed. The research methodology and the schedule of activities should be feasible and realistic. This means that the materials, equipment, and facilities are available for intended use, and the results are obtainable at an expected deadline. When needed, you can resort to a Brief Research Proposal Template  with customizable content, as shown above.

4. One-Page Proposal Template

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One of the essential elements in a clinical research proposal should be a well-written and timely research question that your study will focus on. Your objectives should be aligned with your thesis statement . In the same manner, your methods should closely follow the study’s objectives. The proposal is an outline of your strategy. And like any strategy, there should be thorough planning before the execution. The document will guide you while conducting research. You will be able to monitor your progress and if you have answered your problem statement and objectives. Gather all these important elements in one short research proposal. Luckily, you may use the  One-Page Proposal Template we’ve embedded above. Try it out now!

5. Nursing Research Proposal Template

A research proposal should indicate the background of the study. It should also include a review of related literature about the problem that you plan on addressing. The literature review should point to previous significant works that the researchers would use as a reference citing in their study. This applies when creating a nursing research or case study too. With the help of the  Nursing Research Proposal Template  shown above, crafting an informative and accurate research proposal while in nursing school will be easier.

6. Free Clinical Research Proposal Sample

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A good research proposal , like this sample, provides the reader with a research problem that talks about a current issue, the realistic goal of your research, and a well-explained methodology that will allow other researchers to replicate and verify your study. The specific amount and measurements, for example, should be indicated in your procedure. You must report the statistical analysis that you will perform on your data. Your statistical analysis will influence your results. Therefore, the reader must be informed on how you will treat your data. If you do not include a literature review, present a list of credible references that you will be using throughout your study.

7. Research Proposal Example

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For your reference on what makes for a compelling research proposal, you can download the sample  Research Proposal Example  embedded above. It is made by a person who qualified for the research program of the Mississippi State Department of Health. The document features a title that catches the attention of the reader. Because a person reads the title first, it can create an urge for the reader to keep reading what the writer has to say. The more content is read, the higher the chance that the proposal can sway support to your side. The research problem is relevant to the medical field and society, and the writer explains why it should be addressed. The writer expressed his or her plan on how the study will be performed. You can model your research proposal after this sample if you intend to try for a research program. Take note of the proposal guidelines for other agencies, though, as the requirements may be different.

8. Blank Research Proposal Template

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Now that you are ready to prepare a convincing research proposal, you can use the  Blank Research Proposal Template featured above. It guides you on what to include in the document. You can look for a current issue or problem in the news. Identify a field or a broad topic you wish to study, and read on scientific journals about it. As you read, you can find gaps in the literature. You can also refer to the recommendations in some research articles for help in your next research topic. You can create a flow chart along the way so you will have a guide on your project. Remember the tips you have learned in this article and incorporate them into your proposal.

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The goal of a research proposal is twofold: to present and justify the need to study a research problem and to present the practical ways in which the proposed study should be conducted. The design elements and procedures for conducting research are governed by standards of the predominant discipline in which the problem resides, therefore, the guidelines for research proposals are more exacting and less formal than a general project proposal. Research proposals contain extensive literature reviews. They must provide persuasive evidence that a need exists for the proposed study. In addition to providing a rationale, a proposal describes detailed methodology for conducting the research consistent with requirements of the professional or academic field and a statement on anticipated outcomes and benefits derived from the study's completion.

Krathwohl, David R. How to Prepare a Dissertation Proposal: Suggestions for Students in Education and the Social and Behavioral Sciences . Syracuse, NY: Syracuse University Press, 2005.

How to Approach Writing a Research Proposal

Your professor may assign the task of writing a research proposal for the following reasons:

• Develop your skills in thinking about and designing a comprehensive research study;
• Learn how to conduct a comprehensive review of the literature to determine that the research problem has not been adequately addressed or has been answered ineffectively and, in so doing, become better at locating pertinent scholarship related to your topic;
• Improve your general research and writing skills;
• Practice identifying the logical steps that must be taken to accomplish one's research goals;
• Critically review, examine, and consider the use of different methods for gathering and analyzing data related to the research problem; and,
• Nurture a sense of inquisitiveness within yourself and to help see yourself as an active participant in the process of conducting scholarly research.

A proposal should contain all the key elements involved in designing a completed research study, with sufficient information that allows readers to assess the validity and usefulness of your proposed study. The only elements missing from a research proposal are the findings of the study and your analysis of those findings. Finally, an effective proposal is judged on the quality of your writing and, therefore, it is important that your proposal is coherent, clear, and compelling.

Regardless of the research problem you are investigating and the methodology you choose, all research proposals must address the following questions:

• What do you plan to accomplish? Be clear and succinct in defining the research problem and what it is you are proposing to investigate.
• Why do you want to do the research? In addition to detailing your research design, you also must conduct a thorough review of the literature and provide convincing evidence that it is a topic worthy of in-depth study. A successful research proposal must answer the "So What?" question.
• How are you going to conduct the research? Be sure that what you propose is doable. If you're having difficulty formulating a research problem to propose investigating, go here for strategies in developing a problem to study.

Common Mistakes to Avoid

• Failure to be concise . A research proposal must be focused and not be "all over the map" or diverge into unrelated tangents without a clear sense of purpose.
• Failure to cite landmark works in your literature review . Proposals should be grounded in foundational research that lays a foundation for understanding the development and scope of the the topic and its relevance.
• Failure to delimit the contextual scope of your research [e.g., time, place, people, etc.]. As with any research paper, your proposed study must inform the reader how and in what ways the study will frame the problem.
• Failure to develop a coherent and persuasive argument for the proposed research . This is critical. In many workplace settings, the research proposal is a formal document intended to argue for why a study should be funded.
• Sloppy or imprecise writing, or poor grammar . Although a research proposal does not represent a completed research study, there is still an expectation that it is well-written and follows the style and rules of good academic writing.
• Too much detail on minor issues, but not enough detail on major issues . Your proposal should focus on only a few key research questions in order to support the argument that the research needs to be conducted. Minor issues, even if valid, can be mentioned but they should not dominate the overall narrative.

Procter, Margaret. The Academic Proposal.  The Lab Report. University College Writing Centre. University of Toronto; Sanford, Keith. Information for Students: Writing a Research Proposal. Baylor University; Wong, Paul T. P. How to Write a Research Proposal. International Network on Personal Meaning. Trinity Western University; Writing Academic Proposals: Conferences, Articles, and Books. The Writing Lab and The OWL. Purdue University; Writing a Research Proposal. University Library. University of Illinois at Urbana-Champaign.

Structure and Writing Style

Beginning the Proposal Process

As with writing most college-level academic papers, research proposals are generally organized the same way throughout most social science disciplines. The text of proposals generally vary in length between ten and thirty-five pages, followed by the list of references. However, before you begin, read the assignment carefully and, if anything seems unclear, ask your professor whether there are any specific requirements for organizing and writing the proposal.

A good place to begin is to ask yourself a series of questions:

• What do I want to study?
• Why is the topic important?
• How is it significant within the subject areas covered in my class?
• What problems will it help solve?
• How does it build upon [and hopefully go beyond] research already conducted on the topic?
• What exactly should I plan to do, and can I get it done in the time available?

In general, a compelling research proposal should document your knowledge of the topic and demonstrate your enthusiasm for conducting the study. Approach it with the intention of leaving your readers feeling like, "Wow, that's an exciting idea and I can’t wait to see how it turns out!"

Most proposals should include the following sections:

I.  Introduction

In the real world of higher education, a research proposal is most often written by scholars seeking grant funding for a research project or it's the first step in getting approval to write a doctoral dissertation. Even if this is just a course assignment, treat your introduction as the initial pitch of an idea based on a thorough examination of the significance of a research problem. After reading the introduction, your readers should not only have an understanding of what you want to do, but they should also be able to gain a sense of your passion for the topic and to be excited about the study's possible outcomes. Note that most proposals do not include an abstract [summary] before the introduction.

Think about your introduction as a narrative written in two to four paragraphs that succinctly answers the following four questions :

• What is the central research problem?
• What is the topic of study related to that research problem?
• What methods should be used to analyze the research problem?
• Answer the "So What?" question by explaining why this is important research, what is its significance, and why should someone reading the proposal care about the outcomes of the proposed study?

II.  Background and Significance

This is where you explain the scope and context of your proposal and describe in detail why it's important. It can be melded into your introduction or you can create a separate section to help with the organization and narrative flow of your proposal. Approach writing this section with the thought that you can’t assume your readers will know as much about the research problem as you do. Note that this section is not an essay going over everything you have learned about the topic; instead, you must choose what is most relevant in explaining the aims of your research.

To that end, while there are no prescribed rules for establishing the significance of your proposed study, you should attempt to address some or all of the following:

• State the research problem and give a more detailed explanation about the purpose of the study than what you stated in the introduction. This is particularly important if the problem is complex or multifaceted .
• Present the rationale of your proposed study and clearly indicate why it is worth doing; be sure to answer the "So What? question [i.e., why should anyone care?].
• Describe the major issues or problems examined by your research. This can be in the form of questions to be addressed. Be sure to note how your proposed study builds on previous assumptions about the research problem.
• Explain the methods you plan to use for conducting your research. Clearly identify the key sources you intend to use and explain how they will contribute to your analysis of the topic.
• Describe the boundaries of your proposed research in order to provide a clear focus. Where appropriate, state not only what you plan to study, but what aspects of the research problem will be excluded from the study.
• If necessary, provide definitions of key concepts, theories, or terms.

III.  Literature Review

Connected to the background and significance of your study is a section of your proposal devoted to a more deliberate review and synthesis of prior studies related to the research problem under investigation . The purpose here is to place your project within the larger whole of what is currently being explored, while at the same time, demonstrating to your readers that your work is original and innovative. Think about what questions other researchers have asked, what methodological approaches they have used, and what is your understanding of their findings and, when stated, their recommendations. Also pay attention to any suggestions for further research.

Since a literature review is information dense, it is crucial that this section is intelligently structured to enable a reader to grasp the key arguments underpinning your proposed study in relation to the arguments put forth by other researchers. A good strategy is to break the literature into "conceptual categories" [themes] rather than systematically or chronologically describing groups of materials one at a time. Note that conceptual categories generally reveal themselves after you have read most of the pertinent literature on your topic so adding new categories is an on-going process of discovery as you review more studies. How do you know you've covered the key conceptual categories underlying the research literature? Generally, you can have confidence that all of the significant conceptual categories have been identified if you start to see repetition in the conclusions or recommendations that are being made.

NOTE: Do not shy away from challenging the conclusions made in prior research as a basis for supporting the need for your proposal. Assess what you believe is missing and state how previous research has failed to adequately examine the issue that your study addresses. Highlighting the problematic conclusions strengthens your proposal. For more information on writing literature reviews, GO HERE .

To help frame your proposal's review of prior research, consider the "five C’s" of writing a literature review:

• Cite , so as to keep the primary focus on the literature pertinent to your research problem.
• Compare the various arguments, theories, methodologies, and findings expressed in the literature: what do the authors agree on? Who applies similar approaches to analyzing the research problem?
• Contrast the various arguments, themes, methodologies, approaches, and controversies expressed in the literature: describe what are the major areas of disagreement, controversy, or debate among scholars?
• Critique the literature: Which arguments are more persuasive, and why? Which approaches, findings, and methodologies seem most reliable, valid, or appropriate, and why? Pay attention to the verbs you use to describe what an author says/does [e.g., asserts, demonstrates, argues, etc.].
• Connect the literature to your own area of research and investigation: how does your own work draw upon, depart from, synthesize, or add a new perspective to what has been said in the literature?

IV.  Research Design and Methods

This section must be well-written and logically organized because you are not actually doing the research, yet, your reader must have confidence that you have a plan worth pursuing . The reader will never have a study outcome from which to evaluate whether your methodological choices were the correct ones. Thus, the objective here is to convince the reader that your overall research design and proposed methods of analysis will correctly address the problem and that the methods will provide the means to effectively interpret the potential results. Your design and methods should be unmistakably tied to the specific aims of your study.

Describe the overall research design by building upon and drawing examples from your review of the literature. Consider not only methods that other researchers have used, but methods of data gathering that have not been used but perhaps could be. Be specific about the methodological approaches you plan to undertake to obtain information, the techniques you would use to analyze the data, and the tests of external validity to which you commit yourself [i.e., the trustworthiness by which you can generalize from your study to other people, places, events, and/or periods of time].

When describing the methods you will use, be sure to cover the following:

• Specify the research process you will undertake and the way you will interpret the results obtained in relation to the research problem. Don't just describe what you intend to achieve from applying the methods you choose, but state how you will spend your time while applying these methods [e.g., coding text from interviews to find statements about the need to change school curriculum; running a regression to determine if there is a relationship between campaign advertising on social media sites and election outcomes in Europe ].
• Keep in mind that the methodology is not just a list of tasks; it is a deliberate argument as to why techniques for gathering information add up to the best way to investigate the research problem. This is an important point because the mere listing of tasks to be performed does not demonstrate that, collectively, they effectively address the research problem. Be sure you clearly explain this.
• Anticipate and acknowledge any potential barriers and pitfalls in carrying out your research design and explain how you plan to address them. No method applied to research in the social and behavioral sciences is perfect, so you need to describe where you believe challenges may exist in obtaining data or accessing information. It's always better to acknowledge this than to have it brought up by your professor!

V.  Preliminary Suppositions and Implications

Just because you don't have to actually conduct the study and analyze the results, doesn't mean you can skip talking about the analytical process and potential implications . The purpose of this section is to argue how and in what ways you believe your research will refine, revise, or extend existing knowledge in the subject area under investigation. Depending on the aims and objectives of your study, describe how the anticipated results will impact future scholarly research, theory, practice, forms of interventions, or policy making. Note that such discussions may have either substantive [a potential new policy], theoretical [a potential new understanding], or methodological [a potential new way of analyzing] significance.   When thinking about the potential implications of your study, ask the following questions:

• What might the results mean in regards to challenging the theoretical framework and underlying assumptions that support the study?
• What suggestions for subsequent research could arise from the potential outcomes of the study?
• What will the results mean to practitioners in the natural settings of their workplace, organization, or community?
• Will the results influence programs, methods, and/or forms of intervention?
• How might the results contribute to the solution of social, economic, or other types of problems?
• Will the results influence policy decisions?
• In what way do individuals or groups benefit should your study be pursued?
• What will be improved or changed as a result of the proposed research?
• How will the results of the study be implemented and what innovations or transformative insights could emerge from the process of implementation?

NOTE:   This section should not delve into idle speculation, opinion, or be formulated on the basis of unclear evidence . The purpose is to reflect upon gaps or understudied areas of the current literature and describe how your proposed research contributes to a new understanding of the research problem should the study be implemented as designed.

ANOTHER NOTE : This section is also where you describe any potential limitations to your proposed study. While it is impossible to highlight all potential limitations because the study has yet to be conducted, you still must tell the reader where and in what form impediments may arise and how you plan to address them.

VI.  Conclusion

The conclusion reiterates the importance or significance of your proposal and provides a brief summary of the entire study . This section should be only one or two paragraphs long, emphasizing why the research problem is worth investigating, why your research study is unique, and how it should advance existing knowledge.

Someone reading this section should come away with an understanding of:

• Why the study should be done;
• The specific purpose of the study and the research questions it attempts to answer;
• The decision for why the research design and methods used where chosen over other options;
• The potential implications emerging from your proposed study of the research problem; and
• A sense of how your study fits within the broader scholarship about the research problem.

VII.  Citations

As with any scholarly research paper, you must cite the sources you used . In a standard research proposal, this section can take two forms, so consult with your professor about which one is preferred.

• References -- a list of only the sources you actually used in creating your proposal.
• Bibliography -- a list of everything you used in creating your proposal, along with additional citations to any key sources relevant to understanding the research problem.

In either case, this section should testify to the fact that you did enough preparatory work to ensure the project will complement and not just duplicate the efforts of other researchers. It demonstrates to the reader that you have a thorough understanding of prior research on the topic.

Most proposal formats have you start a new page and use the heading "References" or "Bibliography" centered at the top of the page. Cited works should always use a standard format that follows the writing style advised by the discipline of your course [e.g., education=APA; history=Chicago] or that is preferred by your professor. This section normally does not count towards the total page length of your research proposal.

Develop a Research Proposal: Writing the Proposal. Office of Library Information Services. Baltimore County Public Schools; Heath, M. Teresa Pereira and Caroline Tynan. “Crafting a Research Proposal.” The Marketing Review 10 (Summer 2010): 147-168; Jones, Mark. “Writing a Research Proposal.” In MasterClass in Geography Education: Transforming Teaching and Learning . Graham Butt, editor. (New York: Bloomsbury Academic, 2015), pp. 113-127; Juni, Muhamad Hanafiah. “Writing a Research Proposal.” International Journal of Public Health and Clinical Sciences 1 (September/October 2014): 229-240; Krathwohl, David R. How to Prepare a Dissertation Proposal: Suggestions for Students in Education and the Social and Behavioral Sciences . Syracuse, NY: Syracuse University Press, 2005; Procter, Margaret. The Academic Proposal. The Lab Report. University College Writing Centre. University of Toronto; Punch, Keith and Wayne McGowan. "Developing and Writing a Research Proposal." In From Postgraduate to Social Scientist: A Guide to Key Skills . Nigel Gilbert, ed. (Thousand Oaks, CA: Sage, 2006), 59-81; Wong, Paul T. P. How to Write a Research Proposal. International Network on Personal Meaning. Trinity Western University; Writing Academic Proposals: Conferences , Articles, and Books. The Writing Lab and The OWL. Purdue University; Writing a Research Proposal. University Library. University of Illinois at Urbana-Champaign.

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Bridging Clinical Investigators and Statisticians: Writing the Statistical Methodology for a Research Proposal

Introduction.

Clinical research is judged to be valid not by the results but how it is designed and conducted. The cliché of ‘do it right or do it over’ is particularly apt in clinical research.

One of the questions a clinical investigator frequently asks in planning clinical research is “Do I need a statistician as part of my clinical research team?” The answer is “Yes!” since a statistician can help to optimize design, analysis and interpretation of results, and drawing conclusions. When developing a clinical research proposal, how early in the process should the clinical investigator contact the statistician? Answer - it is never too early. Statistics cannot rescue a poorly designed protocol after the study has begun. A statistician can be a valuable member of a clinical research team and often serves as a co-investigator. Large multicenter projects such as Phase III randomized clinical trials for drug approval by a regulatory agency nearly always have a statistician (or several) on their team. However, smaller, typically single center studies may also require rigorous statistical methodology in design and analysis. These studies are often devised by young clinical investigators launching their clinical research career who may have not collaborated with a statistician. Many clinical investigators are familiar with the statistical role in the analysis of research data 1 , but researchers may not be as aware of the role of a statistician in designing clinical research and developing the study protocol. In this paper we discuss topics and situations that clinical investigators and statisticians commonly encounter while planning a research study and writing the statistical methods section. We stress the importance of having the statistical methodology planned well in advance of conducting the clinical research study. Working in conjunction with a statistician can also be a key training opportunity for the clinical investigator beginning a clinical research career.

GETTING STARTED ON THE STATISTICAL ANALYSIS PLAN

Why work with a statistician.

The study design, sample size, and statistical analysis must be able to properly evaluate the research hypothesis set forth by the clinical investigator. Otherwise, the consequences of a poorly developed statistical approach may result in a failure to obtain extramural funding and result in a flawed clinical study that cannot adequately test the desired hypotheses. Statisticians provide design advice and develop the statistical methods that best correspond to the research hypothesis. For the planning of a clinical study, a statistician can provide valuable information on key design points as summarized in Table 1 . The statistician can discuss with the clinical investigators questions such as: Is the design valid? Overly ambitious? Will the data be analyzable?

The role of the statistician in developing the statistical plan

Very early in the planning stages, it is important to send the statistician a draft of the proposal. Any protocol changes may affect the required sample size and analysis plans so it is important to meet with the statistician throughout the planning stages and later if modifications have been made to the study design. Before the statistical section can be developed, what information does the statistician need? Questions from a statistician concerning design, power and sample size, and analysis may include:

• What is the research hypothesis?
• What is the type of study design?
• What is the most important measurement (primary outcome variable)?
• What is the type of variable and unit of measurement?
• What is a clinically meaningful difference for the primary outcome?
• How many subjects can be recruited or observed within a study period? How many groups or treatment arms are to be included in your design?
• Will there be an equal number of participants or observations in each group? i.e., what is the allocation ratio?
• How many total evaluations and measurements?
• For repeated measurements, what is the measurement interval?

You are not expected to have all the answers at your first meeting and ongoing conversations with the statistician can serve to develop these ideas. Eventually, the answers to these questions comprise the justification for the design selected, provide the basis for the sample size estimate, and drive the choice of statistical analysis. A brief consultation with a statistician will not be adequate to address these issues. The interaction with a statistician to construct the statistical section is not usually one meeting, email, or phone call. It is a process that will help you think through the design of your study. This is also an excellent opportunity to ask questions and enhance your statistical education. Additionally, the exchange of ideas is beneficial to the statistician who will better appreciate the clinical research question. The discussions with a statistician could lead to changes in study design, such as proposing a smaller, more focused study design to collect preliminary data.

A general outline of the statistical methods section is shown in Table 2 . There may be deviations from this format depending on the particular study design. The statistical write-up is rarely less than one page and may total several pages. Although some clinical investigators trained in statistics do prepare this section, more commonly the statistician constructs and writes up the statistical methods section for grants and protocols in close collaboration with the investigators. However, it is important that clinical investigators develop a conceptual understanding of the proposed statistical methodology. Take advantage of any study design and biostatistics classes offered at your institutions to make statistical collaborations more fruitful.

Outline of the statistical methods section

STUDY DESIGN

Type of design.

Before the statistical section can progress, the study design must be known. Study designs that are commonly used in clinical research include case-control, cohort, randomized controlled design, crossover, and factorial designs. A randomized controlled trial has many features but most commonly incorporates what is called a parallel group design where individuals are randomly assigned to a particular treatment or intervention group. In a crossover study, the subject participates in more than one study intervention phase, ideally studied in a random sequence, such as comparing triglyceride responses within the same individual on a low fat versus a high fat diet.

How do we select participants for the study? There are many types of sampling procedures, the basis of which is to avoid or reduce bias. Bias can be defined as ”a systematic tendency to produce an outcome that differs from the underlying truth”. 2 Although true randomness is the goal of a sampling, it is generally not achievable. The study subjects are not usually selected at random to participate in clinical research. Instead, in most clinical trials, the “random” element in randomization is that the consented subjects are assigned by chance to a particular treatment or intervention. The clinical inclusion and exclusion criteria coupled with informed consent will determine who will be the study participants and, ultimately, to what population the study results will be generalizable.

Sample size

With the study design and the make-up of the study sample determined, the sample size estimates can be obtained. Fundamental to estimating sample size are the concepts of statistical hypothesis testing, type I error, type II error, and power ( Table 3 ). In planning clinical research it is necessary to determine the number of subjects to be required so that the study achieves sufficient statistical power to detect the hypothesized effect. If the reader is not familiar with the concept of statistical hypothesis testing, introductory biostatistics texts and many web sites cover this topic. Briefly, in trials to demonstrate improved efficacy of a new treatment over placebo/standard treatments, the null hypothesis is that there is no difference between treatments and the alternative hypothesis is that there is a treatment difference. The research hypothesis usually corresponds to the alternative hypothesis which represents a minimal meaningful difference in clinical outcomes. Statistically, we either 1) reject the null hypothesis in favor of the alternative hypothesis or 2) we fail to reject the null hypothesis.

Definitions for statistical hypothesis testing

Typically, the sample size is computed to provide a fixed level of power under a specified alternative hypothesis. Power is an important consideration for several reasons. Low power can cause a true difference in clinical outcomes between study groups to go undetected. However, too much power may yield statistically significant results that are not meaningfully different to clinicians. The probability of Type I error (α) of 0.05 (two-sided) and power of 0.80 and 0.90 have been widely used for the sample size estimation in clinical trials. The sample size estimate will also allow the estimation of the total cost of the proposed study.

A clinical trial that is conducted without attention to sample size or power information takes the risks of either failing to detect clinically meaningful differences (Type II error) due to not enough subjects or taking an unnecessarily excessive number of samples for a study. Both cases fail to adhere to the Ethical Guidelines of the American Statistical Association which says “Avoid the use of excessive or inadequate number of research subjects by making informed recommendations for study size”. 3

What information is needed to calculate power and sample size?

The components that most sample size programs require for input include:

• Choose Type I error (alpha)
• Choose Power
• Choose clinical outcome variable and effect size (difference between means, proportions, survival times, regression parameters)
• Variation estimate
• Allocation ratio

Clinical outcome measures

Clearly describe the clinical outcomes that will be analyzed to the statistician. The variable type ( Table 4 ) and distribution of the primary outcome measurement must be defined before sample size and power calculations can proceed. The sample size estimates are mainly needed for the primary outcome. However, providing power estimates for secondary outcomes is often helpful to reviewers.

Variable types and derivations to be described in the statistical analysis plan

Effect size

As an example, suppose a parallel group study is being designed to compare systolic blood pressure between two treatments and the investigators want to be able to detect a mean 10 mm Hg difference between groups. This 10 mm Hg difference is referred to as the effect size, detectable difference, or minimal expected difference.

How is the effect size determined?

Choose an effect size that is based on clinical knowledge of the primary endpoint. A sample size that ‘worked’ in a published paper is no guarantee of success in a different setting. The selected effect size is unique to your study intervention, the specific type of participants in your study sample, and perhaps an aspect of the outcome measurement that is unique to your clinic or laboratory. 4

The investigator and statistician examine the literature, the investigator’s own past research, or a combination of the above to determine a study effect size. To investigate the difference in mean blood pressure between two treatments, the effect size options might be 2 mm Hg, 6 mm Hg, 10 mm Hg or 20 mm Hg. Which of these differences do you need to have the ability to detect? This is a clinical question, not a statistical question. Effect size is a measure of the magnitude of the treatment effect and represents a clinically or biologically important difference. Choosing a 20 mm Hg effect size yields a smaller sample size than a 10 mm Hg effect size since it is easier to statistically detect the larger difference. However, an effect size of 10 mm Hg or smaller magnitude may be more a realistic treatment effect and less likely to result in a flawed or wasted study.

Variation estimates for sample size calculations

In addition to effect size, we may need to estimate how much the outcome varies from person to person. For continuous variables, the variation estimate is often in the form of a standard deviation. If the hypothesized difference in systolic blood pressure is an effect size of 10 mm Hg, a study with a blood pressure standard deviation of 22 mm Hg will have lower power than a study where the standard deviation is 14 mm Hg. For a continuous outcome such as blood pressure, a measure of the variation is another part of the formula needed to compute the sample size. An estimate of variation can be derived from a literature search or from the investigator’s preliminary data. Obtaining this information can be a challenge for both the clinical investigator and statistician.

Table 5 shows sample sizes scenarios for detecting differences in blood pressure when comparing two treatments based on a t-test. A standard deviation of 14 mm Hg is chosen to estimate the variation. Sample sizes are calculated for power of 0.80 and 0.90 at the two-sided 0.05 significance level. Notice that the smaller effect sizes require a larger sample size and that the sample size increases as the power increases from 0.80 to 0.90.

Scenarios for choosing sample size

Determining a reasonable and affordable sample size estimate is a team effort. There are practical issues such as budgets or recruitment limitations that may come into play. A too large sample size could preclude the ability to conduct the research. The research team will assess scenarios with varying detectable differences and power as seen in Table 5 (calculations performed using PS power 5 available at the website < http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/PowerSampleSize >). Typically a scenario can be worked out which is both clinically and statistically viable.

The elements of sample size calculations presented here pertain to relatively simple designs. Cluster samples or family data need special statistical adjustments. For a longitudinal or repeated measures design, the correlation between the repeated measurements is incorporated into the sample size calculations. 6 , 7

Do all studies need sample size and power estimates?

Pilot studies.

Pilot studies may not need a power analysis since they are more about testing the protocol than testing a hypothesis. 8 Sometimes there are no preliminary data and thus pilot data must be obtained to provide estimates for designing for a more definitive study. However, calling a study a pilot study to avoid power analyses and to keep the sample small is misrepresentation. 8

Sample size calculations are necessary when the study goal is precision instead of power. The goal may be to describe the precision of a proportion or mean or other statistic that is to be estimated from our sample. Precision in this context is based upon finding a suitably narrow confidence interval for the statistic of interest, such that the lower and upper limits of the confidence interval include a clinically meaningful range of values. We may want to know how many subjects are required to be 95% confident that an interval contains the true, but unknown, value. For example, how many subjects are needed for 10% precision if we expect a 30% allele prevalence in a genetic study? Instead of power, we estimate the sample size for the desired precision based on a single proportion of 0.30 and summarize by stating “With 80 subjects, the precision for a 30% allele prevalence rate is approximately 10% (95% confidence interval: 21% to 40%).” If greater precision is desirable then the sample size is increased accordingly.

Accounting for attrition

Withdrawal and dropout are unwelcome realities of clinical research. Missing data in clinical trials or repeated measurement studies are inevitable. Consider missing data issues when designing, planning and conducting studies to minimize missing data impact. Sample size estimates are finalized by adjusting for attrition based upon the anticipated number of dropouts.

Randomization plan

Random allocation of subjects to study groups is fundamental to the clinical trial design. Randomization, which is a way to reduce bias, involves random allocation of the participants to the treatment groups. If investigators compare a new treatment against a standard treatment, the study subjects are allocated to one of these treatments by a random process. A general description of the randomization approach may be introduced in the clinical methods section of the proposal, for example, “Treatment assignment will be determined using stratified, blocked randomization”. Specific randomization details will need to be elaborated upon in the statistical methods section, including how the allocation procedure will be implemented, e.g., via computer programs, web site, lists, or sealed envelopes. If stratification is deemed necessary, include in the proposal a description of each stratification variable and the number of levels for each stratum, for instance, gender (male, female), diabetes (type 1, type 2). However, keep the number of strata and stratum levels minimal. 9 Discuss the advantages and disadvantages of the various allocation approaches with the study statistician.

Knowledge of the treatment assignment might influence how much of a dosage change is made to a study treatment or how an adverse event is assessed. Blinding or masking is another component of study design used to try to eliminate such bias. 10 In a double-blind randomized trial, neither the study subjects nor the clinical investigators know the treatment assignment.

Describe the planned blinding scheme. For example, “This is a double-blind randomized study to investigate the effect of propranolol versus no propranolol on the incidences of total mortality and of total mortality plus nonfatal myocardial infarction in 158 older patients with CHF and prior myocardial infarction.” Specify who is to be blinded and the steps that will be taken to maintain the blind. It is important that evaluators such as a radiologists, pathologists, or lab personnel who have no direct contact with the study subjects remain blinded to treatment assignments.

It may be impossible or difficult to use the double-blind procedures in some clinical trials. For example, it is not feasible to design a double-blind clinical trial for the comparison of surgical and non-surgical interventions. Or, blinding might not be completely successful; study personnel may be inadvertently alerted as to the probable treatment assignment due to the occurrence of a specific adverse event. If blinding is not feasible, offer an explanation for lack of blinding procedures in the research proposal.

STATISTICAL ANALYSIS METHODOLOGY

The statistical analysis methods for analyzing the study outcomes are to be carefully detailed. Specifying these methods in advance is another way to minimize bias and maintain the integrity of the analysis. Any changes to the statistical methods must be justified and decided upon before the blind is broken. 11 In the statistical analysis plan not only must the statistical hypotheses to be tested be described and justified but we also detail which subjects and observations will be included or excluded in each analysis.

Analysis data sets

Intention-to-treat analysis

It is crucial to define the primary sample of subjects analyzed in the reporting of clinical trial results. Defined in Table 6 , intention-to-treat (ITT) and per-protocol analyses are commonly reported in medical literature result sections. For a randomized study, intention-to-treat analysis is the gold standard for the primary analysis and the intention-to-treat principle is regarded as the most appropriate criteria for the assessment of a new therapy by the Food and Drug Administration and the National Institute of Health. 12 An intention-to-treat data set includes all randomized subjects, whether or not they were compliant or completed the study. Adhering to the ITT principle mirrors what occurs in clinical practice where a patient may discontinue a medication or miss a clinic appointment. This avoids biases that can result from dropouts and missing data. However, the missing data must not bias the treatment comparisons 13 , otherwise the statistics may not be valid. This type of bias could occur if the dropouts or missed study visits are related to a particular treatment group and are not observed equally across all of the treatments.

From ICH E9: Guidance for Industry - E9 Statistical Principles for Clinical Trials, U.S. Department of Health and Human Services, Food and Drug Administration, September 1998

A true intention-to-treat data set may not be attainable in all clinical trials. There might be no post-randomization or post-treatment data for a study subject who withdraws from the study at the initial study visit. Then the primary analysis might consist of all subjects who took at least one treatment dose or had at least one follow-up visit. 11 Anticipate these possibilities as the study is designed and specify in the statistical analysis plan which subjects and observations will comprise the “full analysis set”. Pre-specification of these data sets prior to statistical analysis is imperative.

Per-protocol analysis

It may be of clinical interest to plan an analysis set which consists of only ‘completers’ or ‘compliers’. A per-protocol analysis, defined in Table 6 , is more likely to be planned as secondary analyses. If the per-protocol analysis results are not consistent with the intention-to-treat analysis results, then closely examine the reasons behind any discrepancy.

Statistical analysis

The statistical analysis plan is driven by the research questions, the study design, and the type of the outcome measurements. The analysis plan includes a detailed description of statistical testing for each of the variables in the Specific Aim(s). If several Specific Aims are proposed, we write an analysis plan for each Specific Aim. Plan descriptive analyses for each group or planned subgroup. If subjects were randomly assigned to groups, it is expected that there will be a description of subject characteristics that include demographic information as well as baseline measurements or co-morbid conditions. Specify anticipated data transformations that may be needed to meet analysis assumptions and describe derived variables to be created such as area under the curve. Incorporate confidence intervals in the analysis plan for reporting treatment effects. Confidence limits are much more informative to the reader than are p-values alone. 14

Statistical details and terminology are not intended to be an obstacle for a young investigator. Instead this is where the statistical expert can be a valuable resource to help the investigators use the appropriate statistical methods and language that address the research hypotheses. Brief statistical analysis descriptions are shown in Table 7 for a randomized study and a longitudinal cohort study. In addition to the general methodology of Table 7 , we explain in the statistical methods section how statistical assumptions or model diagnostics will be evaluated. Describe the hypotheses to be tested with the corresponding statistical tests for the primary, secondary, and exploratory analyses. In the medical literature, statistical analyses such as chi-square and t-tests, analysis of variance, regression modeling, and various nonparametric tests are common. However, the statistician is happy to advise whether these traditional methods are appropriate for the research question at hand or if other approaches would be more suitable.

Statistical analysis plans

Statistics, like medicine, is a large and diverse field; hence statisticians have specific areas of expertise. Some proposals may require one statistician for the design and analysis of medical imaging studies and another statistician for design and analysis of a microarray study. Often a proposal specifies one statistician as the study statistician and another statistician to serve on a Data and Safety Monitoring Board.

Interim analysis

Conducting a planned interim analysis in an ongoing clinical trial can be beneficial for scientific, economic, and ethical reasons. 15 Formal interim analyses include stopping rules for terminating the study early if a treatment shows futility or clear benefit or harm. The termination of the estrogen plus progestin treatment arm of the Women’s Health Initiative clinical trial in 2002 16 when the treatment risks exceeded benefits demonstrates the strong clinical impact of interim analyses. However, interim analyses are not to be undertaken lightly. Taking unplanned repeated looks at accumulating data is problematic. First, it raises the multiple testing issue so that adjustments to control the overall Type I error rate are necessary. Second, the results can interfere with the conduct of the remainder of the study, creating bias. Pocock 17 and O’Brien & Fleming 18 authored the classic approaches for defining statistical stopping rules. The alpha spending function described by DeMets and Lan 19 provides some flexibility for the timing of interim analyses as well as controlling the Type I error rate. Clinical investigators must seriously consider what decisions might have to be made based upon interim analysis results and how this will affect an ongoing study.

OVERLOOKED OR INADEQUATELY DESCRIBED AREAS

Matching in case-control studies.

A weakness that often surfaces in sessions reviewing research proposals is an inadequate description of matching. Matching is commonly used in case-control studies by selecting for each case a control with the same value of the confounding variable. However, in our experience, the term “matching” is used too loosely. To a reviewer matching implies the recruitment of matched pairs. This may not be the intention of the investigators or the planned statistical analysis approach. A proposal that states that the participants will be matched according the gender, race/ethnicity, age, and body mass index would raise quite a few questions because ‘matching’ on all these variables would be quite difficult to achieve in practice. Often what the investigator really would like to insure is that the study groups will be balanced with respect to these characteristics. This is described as “frequency matching”. For continuous variables, such as age, the range that is considered a “match” needs to be specified. Indicate the target age range that is clinically comparable for your study, e.g., within 2 years or 5 years. Avoid matching on variables that are not known confounders as this may lead to loss of power. 20

Missing data prevention

It is well known that dropouts and certain missing data patterns can impact a study’s validity. Since statistical analyses cannot cure all problems associated with missing data, prevention is the best policy. To minimize dropouts and missed study visits, verify that the proposal has included a retention plan. Incorporate study procedures that may help to reduce the amount missing data, such as making regular calls to participants to better maintain contact as the study is underway. Every member of the research team must appreciate the need to reschedule or repeat key study visits or labs to the extent possible if the primary outcome measurement was not obtained. In order to obtain an analysis set that is consistent with the intention-to-treat principle, continue to schedule follow-up visits and collect primary outcome measurements for subjects who have discontinued their assigned treatment.

The integrity of the statistical analysis depends on the quality of the data. Obviously a study must contain high quality data (garbage in, garbage out), but steps to ensure this are frequently overlooked. Describe in the research proposal how data will be collected, de-identified, stored, and protected. It is vital that the clinical research team becomes skilled at data management. Meet with a database expert early to discuss the design of a database and related forms and involve the statistician in the review of the forms. Development of the proper data forms and database prior to study activation is essential.

We have presented guidance to be considered when developing the statistical plan in proposals for clinical and translational research. All these approaches have the common theme of eliminating or reducing bias and improving study quality. Planning the statistical methodology IN ADVANCE is crucial for maintaining the integrity of clinical research. We hope we have conveyed that developing the statistical methods for a research proposal is a collaborative effort between statistical and clinical research professionals.

Writing the statistical plan is a multidisciplinary effort. Both the clinical investigator and statistician on the research team need to carefully review the final product and ensure that the science and statistics correspond correctly. Just as a statistician who can understand the clinical aspect of the research is particularly advantageous, endeavor to learn all you can from the statistical expert. Ask the statistician to explain the rationale of the statistical methodology so you can defend the statistical plans without the statistician at your side. The clinical investigator may not have to know how to perform complex analyses but does need to understand the general statistical reasoning behind the proposed statistical design and analysis. When clinical investigators have a basic proficiency in statistical methodology, not only are collaborations with statisticians more dynamic and fruitful, but the potential to develop into a strong, independent clinical investigator and mentor increases. This leads to the design and execution of more efficient and advanced research, increasing the productivity of the entire research team.

Statistical Resources and Education

What if the researcher does not have funding to support a biostatistician? One option is to include a biostatistician as a co-investigator in your grant proposal to cover salary and supplies needed to implement the statistical methods described in the grant. Hopefully there is a department or division of Biostatistics or related field at your or a nearby institution. If not, long distance collaborations can succeed via conference calls and email. The American Statistical Association (ASA) has an ASA consulting section < http://www.amstat.org/sections/cnsl/ > where a clinical investigator can get assistance in finding a statistical consultant.

Some useful statistical websites for general statistical information and definitions include “The Little Handbook of Statistical Practice” < http://www.tufts.edu/~gdallal/LHSP.HTM >; “HyperStat Online Statistics Textbook” < http://davidmlane.com/hyperstat/index.html >; WISE Web Interface for Statistical Education < http://wise.cgu.edu/index.html >. Clinical trial statistical guidelines are documented in the International Conference on Harmonisation (ICH) Guidance for industry: E9 Statistical principles for clinical trials < http://www.fda.gov/ >. 11

As of September 2009, 46 medical research institutions in the United States have been granted a Clinical and Translational Science Award (CTSA, < www.ncrr.nih.gov/crctsa >). When the CTSA program is fully implemented, it will support approximately 60 centers across the nation. Some CTSA awardees offer biostatistical collaboration or institutional pilot grants for early career clinical investigators in need of statistical expertise. Many of these research centers offer Biostatistics courses or seminar series that are specifically designed for clinical researchers. This paper evolved from a CTSA course, “Clinical Research from Proposal to Implementation”, taught at the University of Texas Southwestern at Dallas. Take advantage of any such course offerings and resources.

A successful research proposal requires solid statistical methodology. The written statistical methods section is the result of teamwork between the clinical investigators and statisticians. Collaborating with a statistician early and often will help the study proposal evolve into a strong application that increases opportunities for scientific acceptance and funding for conducting important clinical research studies.

Acknowledgments

Grant support: NIH CTSA grant UL1 RR024982

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Protocol Templates for Clinical Trials

NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research:

• Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications
• Behavioral and social sciences research involving humans

These clinical protocol templates can be accessed via the secure web-based e-Protocol Writing Tool and as Word templates  

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NOT-OD-17-064 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials

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This page last updated on: July 12, 2021

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Protocol Writing in Clinical Research

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• 1 Professor, Department of Orthodontics, King Saud bin Abdul Aziz University for Health Sciences, College of Dentistry , Riyadh, Kingdom of Saudi Arabia .
• 2 Associate Professor, Department of Oral Surgery, Al Farabi Dental College , Riyadh, Kingdom of Saudi Arabia .
• PMID: 28050522
• PMCID: PMC5198475
• DOI: 10.7860/JCDR/2016/21426.8865

Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition.

Keywords: Academia; Grant; Higher Education; Researcher.

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Writing a protocol for clinical research

A clinical research protocol is one of the most vital components of any study. 

It describes an overview of the research, including the main objectives, study design, and key considerations. It also ensures the safety of study participants and maintains the integrity of clinical data.

The protocol document must be reviewed and approved before the trial can proceed, so it’s important that it is accurate, submission-ready and compliant with regulatory standards

In this guide, we cover the most important steps to follow when writing a clinical research protocol, based on the recommended topics provided by the ICH Good Clinical Practice (GCP) guidelines.

What is a clinical research protocol?

A clinical research protocol is a document that outlines how a clinical trial will be conducted and the clinical trial management processes that will be in place throughout the study. It provides a detailed description of the research objectives, design, methodology, and key study considerations. It also describes the background and rationale behind the research.

As well as outlining the study plan, the research protocol also describes the safeguarding and safety measures that the study will follow.

The main purpose of the research protocol is to outline the study plan, with guidelines for the research to follow. The protocol is formulated around the main research question. As such, the guidelines provided in the study protocol ensure that the trial stays centred around the main aims and objectives of the research.

This is one of the most common types of clinical writing , and is integral to any kind of trial. 

A study protocol can be likened to a cookbook recipe. It contains the precise ingredients, metrics, and methods to follow when cooking – or conducting a clinical trial.

Why a clinical trial protocol is necessary

Research protocols are important for a number of reasons. Mainly, the protocol document provides a definitive plan for how the study will be conducted. 

This is developed to ensure that researchers remain consistent and compliant in their methodology and activities across the trial, resulting in smoother operations and more reliable clinical data.

Under Good Clinical Practice (GCP) regulations, a clinical research protocol is required in order for a trial to commence, and is also required for obtaining ethical approval. Furthermore, the research protocol ensures that the appropriate patient and participant health and safety measures are in place. 

For instance, the protocol outlines the specific safety parameters that the trial will investigate throughout, and how these will be managed and followed up.

How to write a clinical research protocol

According to Good Clinical Practice guidelines, a clinical research protocol should include the following topics:

Title page (general information)

Background information.

• Objectives/purpose

Study design

• Selection and exclusion of subjects

Treatment of subjects

Assessment of efficacy, assessment of safety, discontinuation of the study.

• Quality control and assurance

Ethical considerations

Publication policy.

• Supplements/appendices

The title page is the very front page of the clinical research protocol. This should provide an overview of the following key details:

• Protocol title
• Protocol identification number
• Name and contact details of the sponsor, investigator, monitor and medical expert

The first contents page of the protocol should contain introductory background information about the study. This provides the rationale behind why the study is being conducted, detailing information about what is already known about the treatment or condition.

This should open with the name and description of the investigational product, with an overview of the previous clinical or non-clinical findings that relate to the product. The known potential risks and benefits should be summarised here, alongside supplementary information about the population being studied. 

Next, a description of how the treatment will be administered, dosed, regimented, and the length of time that patients will receive it. The background section will also provide a statement regarding how the trial will be conducted in compliance with the protocol; as well as Good Clinical Practice and any other regulatory standards.

Lastly, this section should include references to relevant literature that provide background information to the trial. 

Study objectives and purpose

This section outlines the primary objective of the research. Whilst every trial has a primary objective, there may also be several secondary objectives to include here, depending on the nature of the study.

The research question should be referenced in this section, alongside the specific objectives that relate to the main question. The objectives should be clear and simple – these are usually listed in a bullet point format.

It’s important to make sure that objectives are achievable within the scope of the proposed study. Whilst it is tempting to cover a wide range of objectives, it’s vital to limit these to realistic, achievable aims.

The study design section provides a detailed description of the trial design, including how the trial will be conducted in order to meet the primary and secondary endpoints of the research. The study design must also support the main objectives outlined in the previous sections.

This section describes the type of trial design that will be used to conduct the study, for example, double-blinded, single-arm, placebo-controlled, or other study designs. Plan this section carefully, detailing all study activities that subjects will undergo. Not only should this outline the type of trial design, but should also explain every relevant detail involved with the design. 

As an example, the trial might use a multi-arm study design. In this case, the protocol document should describe the number of arms, the number of subjects per arm, and the specific procedures involved. Similarly, for a biomarker-based study , describe which specific biomarkers will be used, and how these will be measured.

This should involve the types of observation or intervention that subjects will undergo, details about visits, timescales, data collection, and the sequence of study activities. It’s important to be specific here with the following points:

Observations – provide details of what exactly the research will observe, how the observations will be made, and how frequently. 

Interventions – describe what the intervention is, whether it is in phase 1 , 2 or 3 of research, how it will be administered, how frequently it will be administered, and in what dosages.

Visits – outline the time periods between visits, as well as the frequency, and what will happen at each visit.

Timescales – provide a timeline of when procedures will take place, and in what sequence.

Data collection procedures – describe the specific data collection procedures, and how the research will ensure data accuracy, compliance and subject anonymity.

Selection, exclusion and withdrawal criteria

Eligibility criteria are key in clinical trials. They define the patient population that is being investigated, and are often tailored to meet the aims and objectives of the research. In order to attain a well-defined population, the clinical research protocol outlines subject inclusion and exclusion criteria. 

In this section, the specific characteristics of inclusion and exclusion criteria are covered to provide details on the requirements for study entry. 

Inclusion criteria specifies the characteristics that will be accepted , and exclusion criteria specifies the characteristics that will not be accepted . 

Inclusion and exclusion criteria could specify characteristics such as the stage of disease, age, history of disease(s), smoker status, or body mass index (BMI). It can also include more specific characteristics, such as the molecular profile of the disease – as is often the case in rare disease and oncology research .

Alongside inclusion and exclusion criteria, this section of the study protocol should describe the subject withdrawal criteria. Whilst subjects can withdraw at any point, there may be instances where the investigator or sponsor decide to withdraw subjects. This might be due to safety concerns or non-compliance with trial procedures. 

The grounds for subject withdrawal should be outlined in this section. For example, these might include pregnancy during study duration, or intention to become pregnant, intolerable adverse effects, violation of study protocol, or an endangerment to the subject’s health.

In this section, the protocol should cover key information about the treatment that will be administered to subjects. This should include:

• The name of the product(s) to be administered
• The dose(s) of the products
• Dosing schedules
• The route of administration
• Treatment periods
• Permitted and non-permitted medicines during the trial
• Follow-up periods and procedures
• Monitoring procedures

These details ensure that there is a clear understanding of how subjects are to receive treatment, not only ensuring consistency throughout the trial, but also keeping subjects safe.

Efficacy and safety are two of the most important considerations in clinical research. In order for a study drug to be successful, it must be proven efficacious and safe for use. As a result, the study protocol must clearly specify the efficacy and parameters, alongside supporting information.

Efficacy and safety are split into two sections in the clinical study protocol.

For efficacy, it is important to state the endpoints that would define efficacy. For example, the trial may want to develop a drug that:

• Eliminates specific symptoms (such as headaches, for instance)
• Prevents certain disease symptoms
• Cures a disease
• Delays the onset of symptoms
• Takes effect more quickly

In any case, it’s essential to be specific when defining efficacy parameters.

This section of the study protocol should also cover the procedures for assessing, reporting and analysing efficacy throughout the trial.

Similarly to the assessment of efficacy, it is essential to assess safety parameters in the study protocol. This section should include the primary safety endpoints to be measured, with details on how these will be assessed, reported and analysed. 

Examples of safety parameters might include:

• Vital signs, such as blood pressure, pulse rate and ECGs.
• Physical signs, such as heart, lung, and weight measurement.
• Laboratory tests, such as toxicity indications, red blood cell count, and white blood cell count.

The clinical research protocol should also provide definitions of adverse events, defining adverse and serious adverse events separately. The intensity of adverse events should also be defined, with guidelines on how to judge mild, moderate and severe adverse reactions.

Finally, this section should describe how the study will follow up adverse events, including the type of follow up and duration.

Much of the research protocol will focus on what happens during the study, but there should also be a statement on what happens at the end of the study (often referred to as the ‘study close’).

Discontinuation procedures should describe the steps taken to bring the study to a close. For instance, patients will no longer receive investigational treatment, all databases will be locked for analysis and there will be checks to ensure that all data has been collected. 

This section of the research protocol provides a description of the statistical methods used in the study. This should cover all statistical considerations, such as methods, timings, number of subjects, and sample size.

This will also include the level of significance that will be used, and procedures for handling missing or unused data. 

Quality Control and Assurance

This section of the research protocol outlines the quality control measures that will be put into place throughout the study. 

For example, a description of the systems, clinical data management procedures, training, instruction manuals, and auditing procedures. 

The research protocol should state ethical considerations of the study in line with Good Clinical Practice regulations, as well as any local regulations or laws.

This section commonly outlines subject confidentiality procedures, stating the rights of patients and participants in the trial. For instance, their right to withdraw at any point throughout the study, and how the trial will comply with this right. 

Similarly, the study protocol’s ethical section should state the responsibility of the investigator to obtain signed informed consent from subjects prior to participation in the trial.

The protocol should outline the sponsor’s publication plans where necessary, describing what will happen following the study close. For instance, who will have the rights to publication, and where the data will be published. It may also indicate whether the raw data will be accessible all together. 

The publication policy is sometimes addressed in a separate agreement to the research protocol document. If not, then it is usually included in the protocol.

References to all cited data and research sources should be included here. This should be numbered sequentially, attributing to numbered references cited in the text. This helps maintain the protocol’s validity with supporting background data or research. 

The clinical research protocol should end with an appendices section. This includes all documents that are to be submitted with the protocol for review. For example, subject consent forms, participant manuals, and any other documents referenced in the protocol.

Final thoughts

Writing a clinical research protocol is a challenging task. There are a large number of factors and steps to consider when describing the scope of the research. Though nonetheless, it’s essential to cover them in the protocol. 

From study background, trial design, ethical considerations and key definitions, it’s important to provide a comprehensive overview of the research, and provide specific guidelines on study procedures. 

Without the protocol, clinical trial procedures risk becoming inconsistent, unsafe, and noncompliant. 

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