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

Cancer Mortality: U.S ACS Cancer Facts & Figures, 2000.

NIH Funding by Disease Mortality Rate DiseaseDeaths/100,000*NIH funding** HIV-AIDS4.0 $2,900,000,000 Colo-Rectal Cancer19.6$295,000,000 Breast Cancer (female)25.5$693,000,000 Prostate Cancer28.1$379,000,000 Lung Cancer54.9$296,000,000 * 2007 CDC, United States (Table MF); ** 2008 NIH

Extramural Program Responsibilities: Similar to other Institutes Scientific Program Management and Administration Manage grant portfolio Monitor scientific progress Analyze and evaluate grant and contract programs Program Leadership and Development New Initiatives Advice and Guidance to Prospective Applicants Respond to public, patients, and Congress Respond to scientific/professional communities

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

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

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”

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 8-9 th 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

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

NCI Funding Opportunities Websites: Major grant types Research Single project Multi-project Clinical Trial Support Training and Career Development Small Business

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”

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

Research Applications R01: Standard Research Grant for “investigator initiated research” Single project 2-4 years 5 th 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

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)

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

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!!!

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]

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]

Application Process (E-forms) Electronic forms are on the NIH web site NIH Form 398 standard for most applications 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

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 Lists special programs for which grants are being sought