NIH Mentored Career Development Awards (K Series) Part 3

1. NIH Mentored Career Development Awards (K Series) Part 3 Thomas Mitchell, MPH Department of Epidemiology & Biostatistics University of California San Francisco

2. Writing a competitive mentored K award grant application • 4 main sections of the grant application: • The Candidate • Statements by Mentors, Co-Mentors, and Collaborators • Environment and Institutional Commitment to Candidate • Research Plan • Specific Aims • Background and Significance • Preliminary Studies • Research Design and Methods

3. Section 4: Research Plan • Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. • Nevertheless, a fundamentally sound research plan must be provided. • For candidates who require substantial didactic training as part of their program, the research plan may cover less than the full period of the award.

4. Strategies that work –Mistakes to avoid • Build a team: Don’t try to go it alone! • Seek opportunities for collaboration. • Identify collaborators to fill gaps in your expertise, especially a mentor or collaborator who is well known. • Consider multidisciplinary approaches. • Recruit senior colleagues who can provide advice and periodic peer-review of your grant application (e.g., overall scope, specific aims, methods)

5. Strategies that work –Mistakes to avoid (cont’d) 2. Find a good idea:The idea must be creative, exciting, and worth funding. • Concentrate ideas in your area of expertise that would make an impact on public health. • Do your homework; make sure your topic fills a gap in the existing literature. • Pose interesting, testable hypotheses, whenever possible. • Brainstorm potential topics with mentors and colleagues.

6. Strategies that work –Mistakes to avoid (cont’d) • Keep in mind that your topic should fit the mission of the NIH, which is to increase our understanding of biologic processess, diseases, treatments, or prevention. • Just moving science forward is not enough; so, tie your science to curing, treating, or preventing disease. • You will be judged on the likelihood that your research can make an impact on public health.

7. Strategies that work –Mistakes to avoid (cont’d) 3. Less is more: Don’t bite off more than you can chew! • An overly ambitous grant application can make reviewers question your ability to achieve your goals and also to wonder whether the project has been thoroughly thought through with your mentors. • Many grant applications are not funded because they propose to do too muchand are viewed as lacking focus.

8. Strategies that work –Mistakes to avoid (cont’d) • For new investigators, reviewers will be more inclined to give you a fundable score if you bite off less work to do. • Remember: Focus, focus, focus

9. Strategies that work –Mistakes to avoid (cont’d) 4. Don’t procrastinate:Time is your greatest resource and your most important asset. • Get started early (at least 4-6 months before grant appliction is due). • Make steady progress; arrange dedicated time each week for grant-writing. • Get good peer review before you submit. • Submit only your best work; shoot for funding on the 1st round!

10. Distinctive Features of a Research Plan for a Mentored K award • 3 key things to remember when designing a research plan for a K award. 1. The research plan is a training vehicle. The research plan should be well integrated with your career development training plan. 2. The research plan is a means to achieve independence. The research plan should be viewed as a precursor for a subsequent R01.

11. Distinctive Features (cont’d) 3. Mentored K awards provide limited funding. The scope of the research plan needs to be appropriate and feasible, given the modest resources available in a mentored K award. • A “modular” approach is possible, which might include several small projects, such as secondary analyses of existing data, leveraging ongoing cohort studies or clinical trials, or conducting a small pilot study.

12. Specific Aims • Length: 1 page • Style: Non-technical. Write this section for all study section members, since they’ll all read it. • Function: After reading a well-written Specific Aims section, a reviewer must understand the following: • The problem being addressed and the long-term goals of the research. • The hypothesis(s) being tested. • The methodologic approach and feasibility of the project. • The potential impact of the findings.

13. Specific Aims (cont’d) • Introductory paragraph(s): • Begin by stating the general purpose or long-term goal of your research in terms of its relevance to the mission of the NIH (i.e., improving the diagnosis, treatment, and prevention of disease). • The long-term goal should be broad enough to give the impression that this study is part of a larger research plan that will continue beyond the bounds defined in the Specific Aims.

14. Specific Aims: Introductory Paragraph(s), cont’d • Clearly state the problem to be addressed • Scope of the problem (describe importance of the problem, such as number of people affected, morbidity/mortality, costs to society). • Nature of the problem (what we don’t know that we need to know in order to move forward; provides rationale for specific aims).

15. Specific Aims: Introductory Paragraph(s), cont’d • Describe your methodologic approach to the problem (e.g., RCT, observational cohort, case-control study). • Describe scope of project and its feasibility (e.g., availability of subjects, leverging existing resources or infrastructure).

16. Specific Aims • Each aim should consist of one sentence: be concise, concrete, and operational. • Keep the number of aims to a minimum (2-4). • Aims should be able to “stand alone”: keep aims related but independent of the successful outcomes of the previous aim. • State interesting, testable hypotheses, whenever possible. • Include rationales, when needed. • See Examples 1 and 2.

17. Integration of research plan with career development plan • At the end of the Specific Aims section, describe how the research plan is integrated with the career development plan (give concrete examples). • “Each of these specific aims is designed to provide me with the necessary skills and experiences to become an independent health services researcher. My long-term goals are two-fold: (1) to develop interventions to help clinicians better prescribe warfarin, and (2) to better describe risk factors for poor warfarin outcomes in an effort to improve existing risk stratification tools.”

18. Example (cont’d) • “In Aim 1, the research plan will provide experience in longitudinal data analysis, propensity score analysis, outcomes assessment, cost-benefit analysis, and pharmacoepidemiology. Aim 2 will provide experience in prospective data collection, development of an independent cohort, and assessment of patient functional status and frailty. Aim 3 will provide experience developing a decision support intervention and obtain pilot data for the subsequent intervention study.”

19. Example (cont’d) • “Additionally, each of these aims clearly comprises a necessary precursor for my anticipated R01 application. For example, Aims 1 and 2 will provide crucial data on the risk factors, rates, and outcomes of warfarin-associated hemorrhage. Aim 3 will incorporate these data into a user-friendly decision tool that helps clinicians balance the risks and benefits of warfarin.”

20. Example (cont’d) • “Thus, this study will provide important pilot data in preparation for a larger practice-based intervention study investigating the effect of this decision tool on clinician prescribing of warfarin, patient understanding of the risks and benefits of warfarin, and on stroke and hemorrhage outcomes.”

21. Background and Significance • In writing this section, keep in mind that you are writing for a general audience that is “uninformed (about your topic) but intelligent,” so you should write this section in non-technical language. • Length: 3 pages

22. Significance • After reading the aims and hypotheses, the reviewer should have a pretty clear picture of what you plan to do. • Now, they want to know why you want to accomplish these aims. • This is where many applications fall flat. • They fail to make a compelling case for their research project, leaving reviewers with no answer to the big question: SO WHAT?

23. Signficance(cont’d) • Describe the signficance of your research at the beginning of the Background and Significance section. Do not be subtle – deliver your message fast. • State the importance of the problem. • If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? • What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

24. Signficance(cont’d) • Emphasize what is innovative about your research. • Examples: Challenging existing paradigms, testing novel hypotheses, using newly developed state-of-the-art measurements. • Discuss the potential impact of your research; Relate your anticipated results to the longer-term, big picture scientific objectives and to the betterment of health. • See Example 3.

25. Background • This section is important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it. • Reveal that you are aware of gaps or discrepancies in the field. • When identifying gaps in the literature that are relevant to your research project, always indicate how your specific aims will address these gaps. • Remember to cite the literature that supports your hypotheses. • Identify the next logical stage of research beyond your current application.

26. Background(contd’) • Writing tip: • Use bolded subheadings that convey the main point of each section (i.e., a “topic sentence” subheading rather than just a “topic” subheading). For example: • Topic subheading: HIV infection and atherosclerosis. • Topic sentence subheading: Patients with HIV infection develop premature or accelerated atherosclerosis.

27. Background(contd’) • Thus, by reading only the bolded topic sentence subheadings, reviewers can understand the basic argument you are trying to make. • They also make it easier to write a short, cogent background section. • See Examples 4 and 5.