Principles of Clinical & Translational Research “ The Grant Proposal ”

Principles of Clinical & Translational Research “The Grant Proposal” Julio A. Ramirez, MD, FACP Professor of Medicine Chief, Infectious Diseases Division, University of Louisville Chief, Infectious Diseases Section, Veterans Affairs Medical Center Louisville, Kentucky, USA

Clinical & Translational Research The Grant Proposal 1. Definitions 2. Sources of funds for clinical research 3. NIH grants and contracts 4. The application form “SF 424”

Clinical & Translational Research Elements of the Grant Proposal The Protocol The detail written plan of the study The Proposal A document written for the purpose of obtaining funds The proposal contains the study protocol, the budget, the study timeline, and other administrative and supporting documents

Funding Your Clinical Research There are five main sources to fund your clinical research 1. Support from your Mentor 2. Intramural Support 3. Industry Support 4. Private Foundations 5. Government: NIH / VA

Funding Your Clinical Research Industry Support Company-initiated study Investigator-initiated study Phase 2 studies Phase 4 studies Phase 3 studies Phase 4 studies

The Process of Clinical Research Industry: Drug Research & Development Investigational New Drug (IND) Application New Drug Application (NDA) A B C D Laboratory Studies Clinical Studies Drug Approval Post-Marketing Clinical Studies Animal Studies Phase 1: provides initial information on pharmacokinetic and safety of the drug Phase 2: provides initial information on the effectiveness of the drug Phase 3: provides additional information on the effectiveness and safety of the drug

The Process of Clinical Research Industry: Drug Research & Development Investigational New Drug (IND) Application New Drug Application (NDA) A B C D Laboratory Studies Clinical Studies Drug Approval Post-Marketing Clinical Studies Animal Studies Phase 1: provides initial information on pharmacokinetic and safety of the drug • Phase 4: studies may be done in order to • - Refine dosing schedules • - Monitor adverse drug reactions • Support drug indication • Support new indication • - Obtain approval for new indication Phase 2: provides initial information on the effectiveness of the drug Phase 3: provides additional information on the effectiveness and safety of the drug

Funding Your Clinical Research Private Foundations Institute-initiated Investigator-initiated Request for grant application Grant application

Funding Your Clinical Research Government: NIH / VA/CDC/ Institute-initiated Investigator-initiated Request for Application for a grant Individual research grant application

Clinical & Translational Research Elements of the Grant Proposal NIH Grant Basics Submitting a Grant Application: 1. Unsolicited proposal / Investigator initiated 2. Responding to a specific program announcement (PA) or request for application (RFA)

Clinical & Translational Research Elements of the Grant Proposal NIH Grant Basics Different kinds of grant programs: R01: large multi-year (up to 5) primary research project R03: Smaller 1-3 year project The SF 424 is used R21: R21: Larger budgets for innovative research projects

Clinical & Translational Research

Clinical & Translational Research Elements of the Grant Proposal NIH: “SF424 (R&R)” SF424 (R&R): Standard Form 424 Research and Related The SF 424 is used government-wide to apply for all Research and Research-related grants

Clinical & Translational Research Elements of the Grant Proposal NIH: “SF424 (R&R)” Research Plan (the heart of the application) Protection of Human Subjects Personnel Biosketches Budget Resources

Clinical & Translational Research Elements of the Grant Proposal NIH: “SF424 (R&R)” Research Plan (the heart of the application) Protection of Human Subjects Personnel Most proposals are written by a “team” Biosketches Budget Resources

Clinical & Translational Research Elements of the Grant Proposal The NIH Grant Proposal: SF 424 Research Plan 1. Specific Aims 2. Research Strategy 2.A. Significance 2.B. Innovation 2.C. Approach

Clinical & Translational Research Elements of the Grant Proposal The NIH Grant Proposal: SF 424 Research Plan 1. Specific Aims 2. Research Strategy Work from an “Outline” 2.A. Significance 2.B. Innovation 2.C. Approach

Clinical & Translational Research Elements of the Grant Proposal Specific Aims The big picture of your application One page A. Goals of the proposed research B. Summarize the expected outcomes C. Impact that the results of the proposed research will exert on the research fields involved.

Clinical & Translational Research Elements of the Grant Proposal Specific Aims: “Outline” • Relevance/Importance (big picture) • The problem • Preliminary data (rational for hypothesis) • Central/overall hypothesis • Long term goal • Specific aims: • Specific aim 1 Specific aim 2 • Hypothesis 1 Hypothesis 2 • Approach 1 Approach 2

Clinical & Translational Research Elements of the Grant Proposal Significance *Explain the importance of the problem that the proposed project addresses. *Explain how the proposed project will improve scientific knowledge and/or clinical practice. *Describe how the concepts, treatments, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Clinical & Translational Research Elements of the Grant Proposal Innovation • Explain how the application challenges and seeks to shift current research or clinical practice paradigms. • Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions • Explain any advantage over existing methodologies, instrumentation or interventions

Clinical & Translational Research Elements of the Grant Proposal Approach: “Outline” • Preliminary Work • Study Design • Organizational Approach • Study Population • Experimental Design & Analysis • Data Management • Strengths & Limitations • Study Timeline • Summary and Conclusions

Clinical & Translational Research Elements of the Grant Proposal The Reviewer Keep it relevant Keep it simple Keep it short Keep it logical

Principles of Clinical & Translational Research “ The Grant Proposal ”