Methods in Clinical Research: Research Funding and Career Development Michael B. Amey Associate Dean Office of Research Administration July 18, 2013 Research Funding and Career Development Sources of Medical School Revenue Primary Research Sponsors Kinds of Support Primary Initial NIH Grant Types Where to find NIH Information Success Rates Institutional Resources Usual Sequence Research Funding and Career Development Sources of Medical School Revenue 1
Research Funding and Career Development Primary Research Sponsors Sponsored Project Sources Johns Hopkins School of Medicine (Awards) 6 2
NIH Grants and Total Sponsored Expense Johns Hopkins SOM (NIH Grants Do Not include Contracts and ARRA) 1000 900 800 700 600 500 400 2008 2009 2010 2011 2012 Fiscal Year # NIH Grants $ Spon Expense (Millions) $ NIH Grants (Millions) FY 2012 NIH Grant Awards (does not include ARRA or Contracts) Medical School Rank RANK SCHOOL $(Millions) 1 UCSF 445 2 Johns Hopkins 436 3 Penn 381 4 Washington Univ 360 5 Yale 340 6 Pittsburgh 325 7 Univ of Washington 310 8 Univ of Michigan 309 9 UCSD 305 10 Duke 295 November 16, 2012 3
Primary Sponsor Types Federal (72%) NIH provides the majority of the federal support NSF is less than 1% PHS and other Federal are each about 2% Primary Sponsor Types Other (20%) Disease Specific (small grants and fellowships) Foundations (usually targeted) State and Local Government (service and demonstration) Subcontracts from peer institutions Primary Sponsor Types Commercial (8%) Evaluation of Products Development of JHU inventions Some collaborative research 4
Research Funding and Career Development Kinds of Support Kinds of Support Gifts No benefit to donor Can restrict purpose No specified project 5
Kinds of Support Grants (assistance for a specified project) Fellowships Training Grants Career Development Awards Research Projects Program Project and Center Grants Kinds of Support Cooperative Agreements (federal assistance with program control) NIH Multi-Center Clinical Trials Contracts (acquisition of materials or services) Defines a deliverable material or service Federal are usually cost-reimbursement Commercial clinical trials usually fee based Research Funding and Career Development Primary Initial NIH Grant Types 6
Primary Initial NIH Grant Types F 32 Post-doctoral Fellowship Career Development Awards K (01-02) Mentored/Independent Research Scientist Award K 08 Mentored Clinician Scientist Development Award K 23/24 Mentored/Mid-Career Patient Oriented Research Career Development Award Primary Initial NIH Grant Types Research Project R 01 Research Project Grant usually Investigator Initiated R 21 Exploratory & Development Awards Research Funding and Career Development Success Rates 7
July 15, 2010 10:00 11:00 NIH Award Rates Initial Grant Mechanisms FY 2012 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% F 32 K 01 K 08 K23 K 99 R 01 Equiv R21 23 Kirschstein-NRSA post-doctoral fellowships (F32s) Competing applications, awards, and success rates 8
NIH Research Career Development Awards Number of entry-level awards NIH Research Career Development Awards Total funding and average size NIH Research Project Grants Applications, awards, and success rates 9
NIH R01-Equivalent investigators, New (Type 1) Funding rates, by career stage of investigator July 20, 2010 29 10
Research Funding and Career Development Institutional Resources Institutional Resources Clinician Scientist Award Institute for Clinical and Translational Research (ICTR) Fund for Medical Research Institutional Resources Clinician Scientist Program To protect research time of promising young clinical faculty Application draft, submitted or already awarded proposal to a peer review sponsor, Ltrs from Dept. Director & 2 others and interview (due Nov and April 1 st ) Reviewed by a senior faculty committee representing basic and clinical disciplines 11
Institutional Resources Clinician Scientist Program Instructor or Assistant Professor who is an active physician clinician with excellent potential for external awards (is/has completed research training) Provides up to $80/yr for a max of 2 yrs to support unfunded research effort up to 75% (max when holding an award >$50K is a CSA of $40K) Institutional Resources ICTR - CTSA Provides patient care costs for investigator initiated clinical research approved by each centers peer review committee Pilot feasibility grants Career development training Navigation, design and statistical support Clinical Research Network, etc. Institutional Resources Fund for Medical Discovery Pilot or matching support for new interdisciplinary/interdepartmental research initiatives that will lead to new extramural support Requires departmental matching of 25% Proposals are due Sep, Jan and May 15 th 12
Research Funding and Career Development Usual Sequence Clinician Scientist Usual Sequence Mentored Clinician Scientist (K-08) or Patient Oriented Research Development Award (K 23) Clinician Scientist Award Research Project Grant (R 01, R 21) July 20, 2010 39 13
40 41 Research Admin Systems COEUS Proposal development, review and submission MyLearning Compliance Courses (HS, Animal Use, COI, Effort, Resp. Conduct, HIPAA, etc.) Research Environment Systems web based protocol review (IRB, ISCRO), edisclose for outside interests and MyRAP (My Research Agreement Place). IACUC is to be added in 2014. CRMS (Clinical Research Management System) Required Registry of studies and subjects with optional schema, data forms, financial, etc. Linked to IRB and EPIC 42 14
July 20, 2010 43 Research Funding and Career Development Sources of Medical School Revenue Primary Research Sponsors Kinds of Support Primary Initial NIH Grant Types Where to find NIH Information Success Rates Institutional Resources Usual Sequence 15