FUNDING FOR CLINICAL
RESEARCH
Jacqueline A. French MD
Professor
Department of Neurology
THINGS TO CONSIDER
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What are my goals
What are my interests
What do I need money for
WHAT ARE MY GOALS?
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To spend at least half of my time in academic
investigation
 OR
To pay for staff in my division (coordinators,
fellows)
 OR
To free up some time from seeing patients
WHAT ARE MY GOALS?

To spend at least half of my time in academic
investigation
Then:
NIH funding best bet
CAREER PLANNING
NIH or other major funding
Career Development awards
Small grants for pilot data
NIH CAREER DEVELOPMENT
AWARDS
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Career development award (K)
Grants (R)
K AWARDS: COMMON FEATURES
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Most require a mentor
Eligibility
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Doctoral degree
US citizen, non-citizen national, permanent
resident
Previous NIH PIs on grants not eligible
Duration 3,4, or 5 years
75% effort
K-23 AWARD
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The purpose : to support the career development of
investigators who have made a commitment to focus
their research endeavors on patient-oriented
research.
Mechanism provides support for a period of
supervised study and research for clinically trained
professionals who have the potential to develop into
productive, clinical investigators focusing on patientoriented research.
K23 applications and awards FY2002
Trends in K awards by NIH institute FY 2002
NCI K awards increasing
NINDS K awards flat/declining
K-23 GRANTING INSTITUTES
National Institute on Aging National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute of Child Health and Human Development
National Institute on Deafness and Other Communication Disorders
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health Sciences
National Eye Institute
National Institute of General Medical Sciences
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
National Center for Complementary and Alternative Medicine
National Center for Research Resources
SMALL GRANTS FOR PILOT DATA
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Look to internal funding
http://www.med.upenn.edu/research/faculty/grantscontracts.shtml
PILOT AND SEED GRANTS
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Many of the SOM’s centers and institutes sponsor pilot
and seed grant programs.
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Institute on Aging
Alzheimer’s Disease Center
The Penn Center for AIDS Research
Cancer Center Institutional Research Grant (IRG) Program
Cancer Center Pilot Projects Program
Diabetes Endocrinology Research Center
Center for Education and Research in Therapeutics
Center for Molecular Studies in Digestive and Liver Disease
Institute for Medicine and Engineering
Penn Genomics Institute
Robert Wood Johnson Health & Society Scholars Pilot Program
UNIVERSITY RESEARCH
FOUNDATION
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Helping junior faculty undertake pilot projects that
will enable them to successfully apply for extramural
sources of funding,
Aid in establishing their careers as independent
investigators.
Helping established faculty perform exploratory
research, particularly on novel or pioneering ideas,
to determine their feasibility and develop preliminary
data to support extramural applications.
UNIVERSITY RESEARCH
FOUNDATION
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Budget. Applications up to $50,000 will be
entertained, but most grants are for no more than
$25,000
Eligibility is limited to University faculty, in any track,
at any professorial level. Instructors and Research
Associates may apply but need to establish (by letter
from the Department chair) that they will receive
appointment as Assistant professors by the following
July 1st.
Applications are accepted twice each year, for
November 1 and March 15 deadlines.
Applications should be limited to 10 pages
Thomas B. and Jeannette E.
Laws McCabe Fund
Fellow and Pilot Awards
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To support junior faculty who initiate fresh
and innovative biomedical and surgical
research projects
Applicants should have received no or limited
external research funding while in their first
through fourth years at the School of Medicine
or the School of Veterinary Medicine at Penn.
Call Dana J. Napier, School of Medicine
Administration, at (215) 573-3221.
PENN RESOURCES
http://project.pennera.upenn.edu/SPIN/
•SPIN (Sponsored Programs Information Network) -- An up-todate listing of funding opportunities from national and
international governmental and private funding sources.
•GENIUS (Global Expertise Network for Industry, Universities
and Scholars) --A searchable expertise profile system that
contains profiles and/or curriculum vitae of investigators who
choose to make their profiles public
•SMARTS (SPIN Matching and Research Transmittal Service) --A
system that matches GENIUS profiles with the SPIN funding
opportunities and automatically delivers daily updates via e-mail
WHAT ABOUT RO1’S
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What funding is available in your area?
First place to look: NIH website
Step # 1-find the right institute
INSTITUTES
National Institute on Aging National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute of Child Health and Human Development
National Institute on Deafness and Other Communication Disorders
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health Sciences
National Eye Institute
National Institute of General Medical Sciences
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
National Center for Complementary and Alternative Medicine
National Center for Research Resources
WHAT ABOUT RO1’S
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Step # 2-go to your granting institute website
NINDS
NINDS
WHAT’S ON THE NIH WEBSITE?
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Example, NINDS
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Information on the pilot study and planning
grant programs
A template clinical trial protocol
An outline of a Manual of Procedures
NINDS Terms of Award for Clinical Research
NIH policies and procedures
Non-NIH sources of major funding for
POR
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Doris Duke Distinguished Clinical Scientist Award (DCSA) ~ 4
awards $1.5m
RWJ Foundation: Scholars in Health Policy Research Program ~
12 pa
Other Government agencies
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Department of Defence (!)
Social security Administration
AHRQ
VA
Larger specialty societies
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AHA
WHAT ARE MY GOALS?



To pay for staff in my division (coordinators,
fellows)
 OR
To free up some time from seeing patients
 OR
Pilot data
OPTIONS FOR FUNDING
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Smaller specialty societies
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SPIN can help
Pharmaceutical
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Investigator initiated
Multicenter trials
Single site trials
Pharmaceutical clinical trials
Clinical research not involving drugs or devices
Sources of help
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Never negotiate price or terms yourself!
For price, seek BA’s help.
For terms, work with University Office of
Research Services.
Contact Terry Fadem; Director, Corporate
Alliances, with any questions on working with
industry. <fadem@mail.med.upenn.edu>
Negotiations
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Work with your counterpart to determine
what total price range they have in mind for
the study.
Spend your time on discussing the science
rather than the details of the business – bring
others in to do that work with you.
Remember: If a company is talking to you –
they want to work with you.
PHARMACEUTICAL FUNDING
Multi-center trials
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May be less lucrative than other sources of funding,
with less “wiggle room”
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Often budget is “per pt”
Cost/benefit ration will drop with less pts recruited-be
realistic! – It may approach zero if recruitment falls short.
Need to include all costs in budget – Work with OHR
budgeting tool is available
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Patient recruitment
Consent form preparation
IRB fee
Record storage
Investigator time
INVESTIGATOR INITIATED
GRANTS
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Make sure you actually
have time/resources to
do the work!
PHARMACEUTICAL FUNDING
Investigator Initiated
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Proposals don’t have to be drug-specific
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If they are, be careful of conflict of interest
Make sure you have open publication rights
Some recently funded non drug-specific
pharmaceutical grants in the epilepsy center
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Pilot EEG for pts post head trauma
Duration of post-ictal state
Validation of new disability scale
Assessment of concomittant meds given to epilepsy pts
SUMMARY
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Be creative
Look for different sources of funding
Think about what your goal is
Don’t become a hamster in the funding
wheel!