principles of clinical & translational research “ the grant proposal ”
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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. - PowerPoint PPT PresentationTRANSCRIPT
Julio A. Ramirez, MD, FACPJulio A. Ramirez, MD, FACPProfessor of MedicineProfessor of Medicine
Chief, Infectious Diseases Division, University of Louisville Chief, Infectious Diseases Division, University of Louisville Chief, Infectious Diseases Section, Veterans Affairs Medical CenterChief, Infectious Diseases Section, Veterans Affairs Medical Center
Louisville, Kentucky, USALouisville, Kentucky, USA
Principles of Clinical & Principles of Clinical & Translational Research Translational Research
““The Grant Proposal”The Grant Proposal”
The Grant ProposalThe Grant Proposal
4. The application form “SF 424”4. The application form “SF 424”
3. NIH grants and contracts3. NIH grants and contracts
1. Definitions1. Definitions
2. Sources of funds for clinical research 2. Sources of funds for clinical research
Clinical & Translational Research Clinical & Translational Research
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
The ProtocolThe 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
The Grant ProposalThe Grant Proposal
Clinical & Translational Research Clinical & Translational Research
4. The application form “SF 424”4. The application form “SF 424”
3. NIH grants and contracts3. NIH grants and contracts
1. Definitions1. Definitions
2. Sources of funds for clinical research 2. Sources of funds for clinical research
Funding Your Clinical Research Funding Your Clinical Research
5. Government: NIH / VA
There are five main sources to fund your There are five main sources to fund your clinical researchclinical research
4. Private Foundations
2. Intramural Support
3. Industry Support
1. Support from your Mentor
Funding Your Clinical Research Funding Your Clinical Research
Industry Support
Investigator-initiatedstudy
Company-initiatedstudy
Phase 3 studies
Phase 4 studies
Phase 4 studiesPhase 2 studies
Industry: Drug Research & DevelopmentIndustry: Drug Research & Development
Post-MarketingClinical Studies
Drug Approval
Clinical Studies
Animal Studies
Laboratory Studies
The Process of Clinical Research The Process of Clinical Research
AA BB CC DD
Investigational New Drug (IND)
Application
New Drug Application
(NDA)
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 informationon the effectiveness and safety of the drug
Industry: Drug Research & DevelopmentIndustry: Drug Research & Development
Post-MarketingClinical Studies
Drug Approval
Clinical Studies
Animal Studies
Laboratory Studies
The Process of Clinical Research The Process of Clinical Research
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
AA BB CC DD
Investigational New Drug (IND)
Application
New Drug Application
(NDA)
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 informationon the effectiveness and safety of the drug
Funding Your Clinical Research Funding Your Clinical Research
Private Foundations
Investigator-initiated Institute-initiated
Grant application
Request for grant application
Funding Your Clinical Research Funding Your Clinical Research
Government: NIH / VA/CDC/
Investigator-initiated Institute-initiated
Individual research
grant application
Request for Applicationfor a grant
The Grant ProposalThe Grant Proposal
Clinical & Translational Research Clinical & Translational Research
4. The application form “SF 424”4. The application form “SF 424”
3. NIH grants and contracts3. NIH grants and contracts
1. Definitions1. Definitions
2. Sources of funds for clinical research 2. Sources of funds for clinical research
NIH Grant Basics
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
Submitting a Grant Application:1. Unsolicited proposal / Investigator initiated2. Responding to a specific program announcement (PA) or request for application (RFA)
NIH Grant Basics
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
Different kinds of grant programs:R01: large multi-year (up to 5) primary research projectR03: Smaller 1-3 year project The SF 424 is used R21: R21: Larger budgets for innovative research projects
The Grant ProposalThe Grant Proposal
Clinical & Translational Research Clinical & Translational Research
4. The application form “SF 424”4. The application form “SF 424”
3. NIH grants and contracts3. NIH grants and contracts
1. Definitions1. Definitions
2. Sources of funds for clinical research 2. Sources of funds for clinical research
Clinical & Translational Research Clinical & Translational Research
NIH: “SF424 (R&R)”
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
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
NIH: “SF424 (R&R)”
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
Research Plan (the heart of the application)
Personnel
Budget
Resources
Biosketches
Protection of Human Subjects
NIH: “SF424 (R&R)”
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
Research Plan (the heart of the application)
Personnel
Budget
Resources
Biosketches
Protection of Human Subjects
Most proposals are written by a “team”
1. Specific Aims
The NIH Grant Proposal: SF 424
2.A. Significance
2.B. Innovation
Elements of the Grant Proposal Elements of the Grant Proposal
2. Research Strategy
Clinical & Translational Research Clinical & Translational Research
Research Plan
2.C. Approach
1. Specific Aims
The NIH Grant Proposal: SF 424
2.A. Significance
2.B. Innovation
Elements of the Grant Proposal Elements of the Grant Proposal
2. Research Strategy
Clinical & Translational Research Clinical & Translational Research
Research Plan
2.C. Approach
1. Specific Aims
The NIH Grant Proposal: SF 424
2.A. Significance
2.B. Innovation
Elements of the Grant Proposal Elements of the Grant Proposal
2. Research Strategy
Clinical & Translational Research Clinical & Translational Research
Research Plan
2.C. Approach
Work from an “Outline”
Specific Aims
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
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.
The big picture of your application
One page
Specific Aims: “Outline”
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
1. Relevance/Importance (big picture) 2. The problem3. Preliminary data (rational for hypothesis)4. Central/overall hypothesis 5. Long term goal 6. Specific aims:
Specific aim 1 Specific aim 2 Hypothesis 1 Hypothesis 2 Approach 1 Approach 2
1. Specific Aims
The NIH Grant Proposal: SF 424
2.A. Significance
2.B. Innovation
Elements of the Grant Proposal Elements of the Grant Proposal
2. Research Strategy
Clinical & Translational Research Clinical & Translational Research
Research Plan
2.C. Approach
*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.
Significance
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
1. Specific Aims
The NIH Grant Proposal: SF 424
2.A. Significance
2.B. Innovation
Elements of the Grant Proposal Elements of the Grant Proposal
2. Research Strategy
Clinical & Translational Research Clinical & Translational Research
Research Plan
2.C. Approach
A. Explain how the application challenges and seeks to shift current research or clinical practice paradigms.
B. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions
C. Explain any advantage over existing methodologies, instrumentation or interventions
Innovation
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
1. Specific Aims
The NIH Grant Proposal: SF 424
2.A. Significance
2.B. Innovation
Elements of the Grant Proposal Elements of the Grant Proposal
2. Research Strategy
Clinical & Translational Research Clinical & Translational Research
Research Plan
2.C. Approach
Approach: “Outline”
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
1. Preliminary Work2. Study Design3. Organizational Approach4. Study Population5. Experimental Design & Analysis 6. Data Management7. Strengths & Limitations8. Study Timeline 9. Summary and Conclusions
The Reviewer
Elements of the Grant Proposal Elements of the Grant Proposal
Clinical & Translational Research Clinical & Translational Research
Keep it relevantKeep it simpleKeep it shortKeep it logical
The Grant ProposalThe Grant Proposal
4. The application form “SF 424”4. The application form “SF 424”
3. NIH grants and contracts3. NIH grants and contracts
1. Definitions1. Definitions
2. Sources of funds for clinical research 2. Sources of funds for clinical research
Clinical & Translational Research Clinical & Translational Research
