Extramural Program and Extramural Program and Funding Opportunities: NCIFunding Opportunities: NCI

David H. Harpole, Jr., M.D.Professor of SurgeryVice Chief of Surgical

SciencesDepartment of SurgeryDuke University Medical

Center

NIH Funding by Adjusted Life-yearsNIH Funding by Adjusted Life-years

Gross et al. NEJM 340 (24): 1881, 1999

NIH Funding by Disease Mortality RateNIH Funding by Disease Mortality Rate

DiseaseDisease Deaths/100,000*Deaths/100,000* NIH funding**NIH funding**HIV-AIDSHIV-AIDS 4.04.0 $2,900,000,000 $2,900,000,000

Colo-Rectal CancerColo-Rectal Cancer 19.619.6 $295,000,000$295,000,000

Breast Cancer (female)Breast Cancer (female) 25.525.5 $693,000,000$693,000,000

Prostate CancerProstate Cancer 28.128.1 $379,000,000$379,000,000

Lung CancerLung Cancer 54.954.9 $296,000,000$296,000,000

* 2007 CDC, United States (Table 1.1.1.2MF); ** 2008 NIH

Research supported by NCIResearch supported by NCI

Basic Science Studies Translational Science Studies Clinical Investigations and Clinical Trials Population-based studies Demonstration and Education Projects

Unique Aspects of NCIUnique Aspects of NCIThe 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 GroupsCooperative 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 NCIUnique 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

Unique Aspects of NCIUnique 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 OpportunitiesNCI 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

Request for Applications (RFA)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)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 ApplicationsResearch 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

Research ApplicationsResearch 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 DevelopmentTraining 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)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:CSR – NCI Study Sections:Oncology 1 Basic Translational (OBT IRG)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:CSR – NCI Study Sections:Oncology 1: Clinical Oncology (CO IRG)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)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

NCI Grant Contact InformationNCI 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