NIH Mentored Career Development Awards (K Series) Part 4 Thomas Mitchell, MPH Department of Epidemiology & Biostatistics University of California San Francisco

Writing a competitive mentored K award grant application Main sections of the grant application: The Candidate Statements by Mentors, Co-Mentors, and Collaborators Description of Institutional Environment Institutional Commitment to Candidate’s Research Career Development Research Plan Specific Aims Research Strategy Significance Innovation Approach

Research Strategy Significance: The positive effect that successful completion of your research project is likely to have by solving an important, NIH-relevant problem. Innovation: A new and substantially different way of addressing an important, NIH-relevant problem, which enables departure from the status quo. The purpose of the Significance and Innovation subsections is to help justify the need for what is proposed. In writing these subsections, 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. Suggested length: Ideally, both subsections combined should not be longer than 1 page.

Significance The Significance subsection is where you begin to increase the level of detail that will extend and validate what was written in the Specific Aims section. Provide a critical analysis of the primary literature that describes the existence of a critical gap in knowledge. This is where you include some of the material that used to be in the “Background” section, which substantiates and validates that there is an important problem. Explain why its continued existence represents an important problem that must be resolved.

Significance (cont’d) Describe the contribution you expect to make. Example: “The proposed research will contribute to our knowledge of the effects of mail order pharmacy by assessing whether mail order use is associated with improved patient safety, appropriate services utilization, and clinical outcomes in diabetes patients.” Write a simple, direct statement regarding why the expected contribution is important. Example: “This contribution will be significant because understanding the effects of mail order pharmacy use on patient safety and clinical outcomes will help health systems design safe and efficient medication delivery systems with the potential to improve CVD-related outcomes in diabetes patients.”

Significance (cont’d) Describe the positive impact your contribution will have. How will your contribution enable subsequent thinking and research? If applicable, call attention to decreased mortality/morbidity, improvements in the quality of life or medical outcomes, reduction in cost of medical care, etc. Example: “Improved medication adherence through mail order pharmacy use has the potential to decrease CVD-related hospitalizations and deaths in diabetes patients. Through a full assessment of the risks and benefits of mail order pharmacy use, we can gain important knowledge on how to potentially improve and expand the use of mail order pharmacy services.”

Innovation Innovation: A new and substantially different way of addressing an important, NIH-relevant problem, which enables departure from the status quo. Examples: Challenging existing paradigms, testing novel hypotheses, using newly developed state-of-the-art measurements. Provide the context (with citations from the literature) so reviewers will be able to understand how your project is innovative. For example, if you plan to assert that innovation stems from a new approach that you will take, you need to support that claim with discussion of previous approaches and why they were unsatisfactory. This is another place where you include material that was previously in the “Background” section.

Innovation (cont’d) Write a statement that begins with the phrase, “The proposed research is innovative because…..” Complete this sentence by stating what objectively sets your project apart, such as a different approach you are taking or a different technology you have created, compared to past investigators. Example: “The proposed research is innovative because it addresses the potential of a healthcare system-level factor – in this case, the provision of mail order pharmacy service – rather than patient-level or provider-level factors to improve patient adherence to medications. “

Innovation (cont’d) Describe the positive impact that will result from your innovative approach. Positive impact under Significance stems from concrete benefit that is relevant to NIH’s mission. Positive impact under Innovation stems from advancement that would have been unlikely without substantive – not incremental – departure from the status quo. Example: “Many researchers and policy makers have lamented that the field of medication adherence research is “stuck” with few good options for moving forward. 3-5 Research that comprehensively assesses the impact of system-level interventions such as mail order pharmacies can significantly advance the field of structural interventions to improve patient health.”

Approach NIH guidelines for this section Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Discuss potential problems, alternative approaches, and benchmarks for success anticipated to achieve the aims. If the project is in the early stages of development, describe any strategy to establish feasibility and address the management of any high-risk aspects of the proposed work. For new applications, include information on Preliminary Studies as part of the Approach section.

Approach (cont’d) Organization of this section: 2 approaches “Modular” approach Each Aim: Introduction Background Preliminary Studies Research Design Expected Outcomes Potential Problems & Alternative Approaches Timeline Future Directions

Approach (cont’d) “Unitary” approach Introduction Background Preliminary Studies Research Design Study design Study population Study procedures Study measurements Data quality and management Data analysis Expected Outcomes Potential Problems & Alternative Approaches Timeline Future Directions