clinical research proposal example pdf

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

Size: A4, US

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

Size: 114 KB

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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19+ SAMPLE Clinical Research Proposal in PDF

Clinical Research Proposal

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1. your target audience, 2. pitfalls that could occur, 3. data and research, 1. define the statement of the problem, 2. present your proposal, 3. extend your research, 4. create a schedule and a budget plan, 5. indicate conclusion, 6. verify that your proposal is error-free, share this post on your network, file formats, word templates, google docs templates, excel templates, powerpoint templates, google sheets templates, google slides templates, pdf templates, publisher templates, psd templates, indesign templates, illustrator templates, pages templates, keynote templates, numbers templates, outlook templates, you may also like these articles, 25+ sample construction company proposal in ms word.

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“Physicians must keep current with the clinical information to practice evidence-based medicine…to answer many of their clinical questions, physicians need access to reports of original research. This requires the reader to critically appraise the design, conduct, and analysis of each study and subsequently interpret the results.” These words emphasized from the study of Donna Windish and others. In this article, we will discuss beneficial steps of creating a proposal for your clinical research , plus we have various examples of a research proposal template  for you to use. Keep on reading!

Clinical Research Proposal

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A proposal for a clinical research is a valuable document that demonstrates primary targets, objectives, and methods or strategies established by the clinical researchers, medicine professionals, healthcare practitioners or scientists in encouraging potential sponsors or medical associations for the implementation of a particular clinical study or trial.

Working as a diligent clinical researcher, you need to fully learn and apply the integral process and skills, enhance your grade, and significantly design a useful end product. In this matter, we suggest that you follow the steps below while freely using one of our sample research proposals in this article:

The first step that you need to accomplish is determining the research problem so that you can set up realistic goals, and objectives in creating a proposal for your clinical research.  The book “ Essentials of Clinical Research ” stated that “research questions are generated in a variety of settings such as during journal reading, hospital rounds, discussions with colleagues, seminars, and lectures. Those questions can be refined into a research idea and, after further review of the literature, ultimately developed into a hypothesis.”

Additionally, the book “ Designing Clinical Research ” described good research questions that came from medical articles and conferences, from critical thinking about clinical practices and problems, from applying new methods to old issues.

The second step that you need to do is collecting and analyzing important resources and necessary data for your clinical study. These systems have been utilized widely in clinical trials to support randomization of research subjects and to collect essential data for the research study. “ The Data Book: Collection and Management of Research Data ” explained that the accuracy and validity of data have a direct effect on the conclusions drawn from them. That’s why data management and research are inevitably connected. 

Thoroughly explain the various kinds of methods and strategies that you are planning to use for your research study . According to the book “ Clinical Trial Methodology ”, clinical trial methodology includes all methods required for the protection of participants in a clinical trial and all methods that are fundamental to provide a valid inference about the objective of the trial. So, you must show a logical chronological order of the methods in all aspects of your clinical trial.

Based on the book ‘Evaluating Clinical Research”, obtaining a special knowledge of biostatistics may help a research evaluator to properly analyze the design of a clinical research trial. Medical and healthcare practitioners should be able to focus on patient issues rather than the statistical and methodological issues. So, you need to be able to critically review what you read. 

Clinical research is important to create top-quality data so that healthcare and medical institutions are able to set up reasonable decisions. By doing a thorough clinical research, many scientific questions can be answered, and solve crucial health issues in our society.

Some different types of clinical research are prevention trials, treatment trials, case control studies, cohort studies, pilot and feasibility studies, cross sectional studies, and many more.

To create an effective clinical study, you need to maintain simplicity and order in your work. Recruit patients and professionals who are integral for the study. Plan accurately the four stages with the aim of your clinical trial. Set up a sufficient budget and resources plan. 

An article published by National Institute of Aging (NIA) explained that “clinical trials are research studies performed in people that are targeted at analyzing a medical, surgical, or behavioral intervention.” Thus, it is an essential method by researchers to know if a new treatment is safe and effective in people.

Ike Skelton once said: “Modern medical advances have helped millions of people live longer, healthier lives. We owe these improvements to decades of investment in medical research.” Therefore, writing a proposal for your clinical research is a significant stepping stone for you to make things happen especially in the near future of healthcare and medical science. So, we recommend that you get a clinical research  proposal template today to begin your clinical research study proposal or trial proposal! 

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• How to Write a Research Proposal | Examples & Templates

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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Research Proposal Example/Sample

Detailed Walkthrough + Free Proposal Template

If you’re getting started crafting your research proposal and are looking for a few examples of research proposals , you’ve come to the right place.

In this video, we walk you through two successful (approved) research proposals , one for a Master’s-level project, and one for a PhD-level dissertation. We also start off by unpacking our free research proposal template and discussing the four core sections of a research proposal, so that you have a clear understanding of the basics before diving into the actual proposals.

• Research proposal example/sample – Master’s-level (PDF/Word)
• Research proposal example/sample – PhD-level (PDF/Word)
• Proposal template (Fully editable) 

If you’re working on a research proposal for a dissertation or thesis, you may also find the following useful:

• Research Proposal Bootcamp : Learn how to write a research proposal as efficiently and effectively as possible
• 1:1 Proposal Coaching : Get hands-on help with your research proposal

FAQ: Research Proposal Example

Research proposal example: frequently asked questions, are the sample proposals real.

Yes. The proposals are real and were approved by the respective universities.

Can I copy one of these proposals for my own research?

As we discuss in the video, every research proposal will be slightly different, depending on the university’s unique requirements, as well as the nature of the research itself. Therefore, you’ll need to tailor your research proposal to suit your specific context.

You can learn more about the basics of writing a research proposal here .

How do I get the research proposal template?

You can access our free proposal template here .

Is the proposal template really free?

Yes. There is no cost for the proposal template and you are free to use it as a foundation for your research proposal.

Where can I learn more about proposal writing?

For self-directed learners, our Research Proposal Bootcamp is a great starting point.

For students that want hands-on guidance, our private coaching service is recommended.

Psst… there’s more!

This post is an extract from our bestselling Udemy Course, Research Proposal Bootcamp . If you want to work smart, you don't want to miss this .

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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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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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How to Write a Winning Clinical Research Proposal?

• First Online: 02 February 2019

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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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Center for Clinical and Translational Science (CCaTS)

Postdoctoral master's degree program, research proposal.

The mentored research experience is a key component of the Postdoctoral Master's Degree Program in clinical and translational science.

Students develop their research proposals in CTSC 5010: Clinical Research Proposal Development, with a deadline based on the academic cycle listed below. Members of the CCaTS Scientific Review Group review research proposals, and the Master's and Certificate Programs Executive Committee approves them.

Include these items in your proposal packet:

• Research Proposal Packet Cover Page (PDF) .
• The proposal. Research proposals are approved by the CCaTS Master's and Certificate Programs Executive Committee and Mayo Clinic Graduate School of Biomedical Sciences (MCGSBS). Follow the Research Proposal Guidelines (PDF) , and construct your specific aims in a way that clearly defines the two or three publications resulting from the proposal.
• Research Proposal Project Timeline form .
• Translational Impact Statement. In one paragraph or a maximum of one page, describe the translational gap that your project will fill. You may include key literature that helped you identify that gap.
• Names. Your name should be first.
• Member expertise. Stick to the expertise that has value for this specific proposal.
• Help collect data?
• Train the student leader on necessary skills?
• Provide mentorship for the student leader for their research?
• Communication. How will the team meet, for example, in person or online? How often? How will the team resolve differences of opinion? What is the structure of meetings? Be clear about how you are situated in this structure.
• Final statement. Include a statement such as, "This team brings together fields of expertise that uniquely allow us to achieve [define a positive outcome]."
• Audience. Remember that you want to be writing for a broad readership. Limit your use of jargon and strive for clarity whenever possible
• Current curricula vitae for you and your mentor.

Thesis Advisory Committee (TAC) form. Complete the Proposed Master Thesis Advisory Committee form (PDF) . All TAC members are expected to provide scientific peer review and approve your proposal prior to submission. After your TAC has been approved by the CCaTS Master’s and Certificate Programs Executive Committee, the program staff will submit the MCGSBS TAC e-form on your behalf.

Read more about the Thesis Advisory Committee .

Verification statement from your department or division. This statement must document that peer review of the proposal has taken place and that the proposed work is scientifically sound and clinically meaningful. The minute excerpt from your department or division research committee or minute excerpt used for submission to the Mayo Clinic Institutional Review Board (IRB) may be used.

Note: If your project is deemed nontherapeutic and minimal risk — for example, a retrospective chart review — the IRB does not require divisional review and the CCaTS Minimal Risk Study form (PDF) is used in lieu of department or division verification.

If the proposal is part of a larger project, submit the abstract and documentation of scientific peer review of the larger project (that is, the minute excerpt from the appropriate research committee or funding agency).

• IRB approval email notification. This email notification documents that IRB review of your proposal was completed and approved. If the IRB has not yet approved your proposal, submit the email notification when approved. If your proposal is part of a larger project, please submit the IRB approval for the larger project.
• Research Proposal Potential Reviewers (PDF) .

Research proposal review criteria

The CCaTS Master's and Certificate Programs Executive Committee considers whether the thesis that will result from the proposal has the potential to meet the prescribed thesis standards and is feasible within the time frame identified. Proposals are reviewed by the CCaTS Scientific Review Group using these criteria:

• Clinical or translational research. Does the project meet the definition of clinical or translational research? If an animal model is being studied, has the scholar justified its significance to human disease?
• Scientific peer review. Is the hypothesis significant? Is the study design valid? Is the data collection and analysis plan consistent with the study goal? Is there statistical justification?
• IRB review. Has IRB approval for the project been obtained, or is it pending? If the scholar's project is part of a larger project, has documentation been provided showing IRB approval for the larger project?
• Authorship. Will the scholar be the first author on publications resulting from this project? If the scholar's project is part of a larger, multiauthor study, has the scholar explained the contribution to authorship? Will the project result in at least one publication?
• Feasibility. Is there sufficient funding for the project? Is there sufficient time to collect data and recruit participants? Does the project align with the scholar's research interests?
• Recruitment plan. Has a satisfactory subject recruitment plan, including a timeline, been provided?
• Current status. Has the status of the project been provided? For example, "Fifty percent of the data are collected, with data collection expected to be complete in six months."

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A research proposal is a paper that proposes a research project, usually in the sciences or engineering, and typically constitutes a funding request for that study. Proposals will be judged on the expense and possible effect of the proposed study, and on the solidity of the proposed plan for its implementation. A clinical research proposal is a paper that proposes a project based on clinical research.

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Step 2: determine the objectives and the scope, step 3: determine your finances and manpower, step 4: state the problems and the solutions, step 5: provide a conclusion, step 6: revise and review, 1: the title page, 2: the cover page, 3: the contents table, 4: the summary, 5: the proposal, 6: the process, 7: the conclusion, more in proposal templates, clinical research project manager resume, biography research template, apa research paper template, research paper outline template, research paper template, contract clinical research associate resume, clinical research trainee resume, clinical researcher resume, clinical research scientist resume, clinical research nurse resume.

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