Extramural Program and Funding Opportunities: NCI

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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

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NIH Funding by Adjusted Life-years
Gross et al. NEJM 340 (24) 1881, 1999
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Cancer Mortality U.S. 1930-1996
ACS Cancer Facts Figures, 2000.
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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
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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

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Research supported by NCI

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

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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

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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

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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

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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 DSMBs
• Designing State of the Science Meeting to
  define future research funding objectives
• Facilitate Interactions across disciplines

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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

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Request for Applications (RFA)

• Specific theme for grants, often from
  recommendations SOS meetings
• Sent to question-specific study section
• RFAs Located on NIH website
• Monies are be appropriated
• Many R21s are from these
• But...limited number to be funded
• Often pre-determined

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Program Announcements (PAs)

• 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

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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 PIs
• Each PI has defined role and grant credit
• A real advantage to synergy
• Traditional benchtop basic scientist
• Translational / clinical scientist

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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)

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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

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Career Development Awards (Ks)

• 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!!!
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CSR NCI Study SectionsOncology 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

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CSR NCI Study SectionsOncology 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

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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.ht
  ml
• 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

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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