principles of clinical & translational research “ the grant proposal ”

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