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Extramural Program and Funding Opportunities: NCI

Extramural Program and Funding Opportunities: NCI. David H. Harpole, Jr., M.D. Professor of Surgery Vice Chief of Surgical Sciences Department of Surgery Duke University Medical Center. NIH Funding by Adjusted Life-years. Gross et al. NEJM 340 (24): 1881, 1999.

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Extramural Program and Funding Opportunities: NCI

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  1. Extramural Program and Funding Opportunities: NCI David H. Harpole, Jr., M.D. Professor of Surgery Vice Chief of Surgical Sciences Department of Surgery Duke University Medical Center

  2. NIH Funding by Adjusted Life-years Gross et al. NEJM 340 (24): 1881, 1999

  3. NIH Funding by Disease Mortality Rate Disease Deaths/100,000* NIH funding** HIV-AIDS 4.0 $2,900,000,000 Colo-Rectal Cancer 19.6 $295,000,000 Breast Cancer (female) 25.5 $693,000,000 Prostate Cancer 28.1 $379,000,000 Lung Cancer 54.9 $296,000,000 * 2007 CDC, United States (Table 1.1.1.2MF); ** 2008 NIH

  4. Research supported by NCI • Basic Science Studies • Translational Science Studies • Clinical Investigations and Clinical Trials • Population-based studies • Demonstration and Education Projects

  5. Unique Aspects of NCI The Good… • Largest Institute (Budget $6B+) • $2.1B Supplement in Stimulus Package • Note: $6B more in 2011 Budget by Obama 3/1/10 • Note: Not approved by Democrats, certainly not by Republicans • Only Institute with Political Appointment (Forces change) • 50+ year history of significant Clinical Trials Support • CALGB, SWOG, ECOG,, RTOG, NCCTG, ACOSOG, COG, GOG, NCI-C, EORTC (more on this later…) • Developed Secondary endpoints:, Quality of Life, Costs

  6. Cooperative Cancer Groups • IOM report recommended streamlining process to improve efficiency and accrual • 9 current adult groups will be 3 (maybe 4) • Applications due 6/2012, funding 1/2013 • ACOSOG/CALGB/NCCTG merged • Leadership opportunities for GTS • Other groups are “dating”

  7. Unique Aspects of NCI The Bad… • The vast majority of $ earmarked for administrative grants • Cancer Center, Cooperative groups, PO1, SPORE, EDRN, etc. • An opportunity exists as this is evolving from single to multiple institution, multiple PI format • Historically lowest pay-line (Now 8-9th percentile) • e.g., CBSS 180 R21, 5 funded 2011, RO1 at 10% • No modality-specific study sections • Exception: Radiation Biology and Imaging • TS projects are mixed in with all scientists for review • 6 RO1 funded GTS by NCI • 2 GTS on NCI-CSR study sections

  8. Unique Aspects of NCI • Intra-and Extramural Programs Re-organized Based on Disease Steering Committees • Thoracic Malignacy Steering Committee • GI Tumor Steering Committee • Membership: Modality Co-chairs • Scientists (SPORE, PO1) • Clinical Investigators (Cooperative Group Disease Chairs) • Community Oncology members • Advocates • NCI Intramural scientists • Missions: • Streamlining Approval of all Phase II and III Clinical Trials • Oversee accrual and DSMB’s • Designing “State of the Science” Meeting to define future research funding objectives • Facilitate Interactions across disciplines

  9. NCI Funding Opportunities • Websites: http://grants.nih.gov http://cancer.gov • Major grant types • Research • Single project • Multi-project • Clinical Trial Support • Training and Career Development • Small Business

  10. Request for Applications (RFA) • Specific theme for grants, often from recommendations SOS meetings • Sent to question-specific study section • RFA’s Located on NIH website • Monies are be appropriated • Many R21’s are from these • But...limited number to be funded • Often “pre-determined”

  11. Program Announcements (PA’s) • Invites grant applications in a specific research area • New or expanded interest in an area, or a reminder of an ongoing interest • Usually No money! • Reviewers note that a grant is responsive to a particular PA

  12. Research Applications • R01: Standard Research Grant for “investigator initiated research” • Single project 2-4 years • 5th year now by special approval • New and established investigators • Can have Multiple PI’s • Each PI has defined role and grant credit • A real advantage to synergy • Traditional “benchtop” basic scientist • Translational / clinical scientist

  13. Research Applications • R21: Exploratory/Developmental Grant • Early and conceptual stages of development • 2 years of funding capped at $275K • Great initial grant: requires no preliminary data • Must have statistical input • R33 validation (3 years) capped at $500K/year • P01: program project grant (and SPORE) • Thematic • Multi-project (requires R01 funded leaders)

  14. Training and Career Development • All Levels of Education and Experience • Specials Programs for under-represented populations and researchers with disabilities • Basic science and clinical research

  15. Career Development Awards (K’s) • K08: Mentored Clinical Scientist • Health Professional Doctoral Degree • Not necessarily clinical research • K23: Mentored Patient-Oriented Research • Analogous to K08 • Develop skills for patient-oriented research • K12 is Center-based K08 or K23 • K24: Mid-career Investigator Award in Patient-Oriented Research • K99: Pathway to independence (R00) • Transitions to RO1 in latter years Note: NCI requires 75% protected non-clinical time!!!

  16. CSR – NCI Study Sections:Oncology 1 Basic Translational (OBT IRG) Cancer initiation, promotion, progression, metastasis • Cancer Molecular Pathobiology Study Section [CAMP] • Cancer Etiology Study Section [CE] • Cancer Genetics Study Section [CG] • Molecular Oncogenesis Study Section [MONC] • Tumor Cell Biology Study Section [TCB] • Tumor Microenvironment Study Section [TME] • Tumor Progression and Metastasis Study Section [TPM]

  17. CSR – NCI Study Sections:Oncology 1: Clinical Oncology (CO IRG) • Clinical patient-oriented research /clinical trials • Pharmacologic and toxicologic studies • Non-behavioral alternative cancer therapies • Research on the treatment of cancer therapy-related • Age-specific issues: tumor behavior with aging, clinical / laboratory assessment of the older patient • Basic Mechanisms of Cancer Therapeutics Study Section [BMCT] • Cancer Biomarkers Study Section [CBSS] • Chemo/Dietary Prevention Study Section [CDP] • Cancer Immunopathology and Immunotherapy Study Section [CII] • Clinical Oncology Study Section [CONC] • Drug Discovery and Molecular Pharmacology Study Section [DMP] • Developmental Therapeutics Study Section [DT] • Radiation Therapeutics and Biology Study Section [RTB]

  18. Application Process (E-forms) • Electronic forms are on the NIH web site • NIH Form 398 standard for most applications • www.grants.nih.gov/grants/funding/phs398/phs398.html • Prepare biosketch and other support NOW! • Each grant mechanism has a different submission deadline • R01/R21 submission • Application due February 1 for December 1 start • Application due June 1 for April 1 start • Application due October 1 for July 1 start

  19. NCI Grant Contact Information • Funded Investigators and Surgical Mentors • Institution Grants and Contracts office • Program staff at NIH • Each Institute has a web site with key personnel listed • Contact specific study section staff for questions • The NIH Guide to Grants and Contracts • www.grants.nih.gov/grants/guide • Lists special programs for which grants are being sought

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