This document provides guidance on funding options for clinical research. It discusses considering one's goals and interests to determine the appropriate funding. National Institutes of Health grants such as K-awards and R01 grants are recommended for spending significant time in academic investigation. Small internal grants can provide pilot data for larger grants. Industry-sponsored clinical trials are another option but require ensuring publication rights and managing conflicts of interest. The document stresses applying to multiple sources and being creative in finding support that aligns with one's research goals.

1. FUNDING FOR CLINICAL
RESEARCH
Jacqueline A. French MD
Professor
Department of Neurology

2. THINGS TO CONSIDER
 What are my goals
 What are my interests
 What do I need money for

3. WHAT ARE MY GOALS?
 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

4. WHAT ARE MY GOALS?
 To spend at least half of my time in academic
investigation
Then:
NIH funding best bet

5. CAREER PLANNING
Small grants for pilot data
Career Development awards
NIH or other major funding

6. NIH CAREER DEVELOPMENT
AWARDS
 Career development award (K)
 Grants (R)

7. K AWARDS: COMMON FEATURES
 Most require a mentor
 Eligibility
– Doctoral degree
– US citizen, non-citizen national, permanent
resident
– Previous NIH PIs on grants not eligible
– Duration 3,4, or 5 years
– 75% effort

8. K-23 AWARD
 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 patient-
oriented research.

9. K23 applications and awards FY2002

10. Trends in K awards by NIH institute FY 2002
NINDS K awards flat/declining
NCI K awards increasing

11. 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
K-23 GRANTING INSTITUTES

12. SMALL GRANTS FOR PILOT DATA
 Look to internal funding
http://www.med.upenn.edu/research/faculty/grantscontracts.shtml

13. PILOT AND SEED GRANTS
 Many of the SOM’s centers and institutes sponsor pilot
and seed grant programs.
– 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

14. UNIVERSITY RESEARCH
FOUNDATION
 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.

15. UNIVERSITY RESEARCH
FOUNDATION
 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

16. Thomas B. and Jeannette E.
Laws McCabe Fund
Fellow and Pilot Awards
 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.

17. PENN RESOURCES
http://project.pennera.upenn.edu/SPIN/
•SPIN (Sponsored Programs Information Network) -- An up-to-
date 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

18. WHAT ABOUT RO1’S
 What funding is available in your area?
 First place to look: NIH website
 Step # 1-find the right institute

19. 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
INSTITUTES

20. WHAT ABOUT RO1’S
 Step # 2-go to your granting institute website

21. NINDS

22. NINDS

23.  Example, NINDS
– 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
WHAT’S ON THE NIH WEBSITE?

24. Non-NIH sources of major funding for
POR
 Doris Duke Distinguished Clinical Scientist Award (DCSA) ~ 4
awards $1.5m
 RWJ Foundation: Scholars in Health Policy Research Program ~
12 pa
 Other Government agencies
– Department of Defence (!)
– Social security Administration
– AHRQ
– VA
 Larger specialty societies
– AHA

25. 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

26. OPTIONS FOR FUNDING
 Smaller specialty societies
– SPIN can help
 Pharmaceutical
– Investigator initiated
– Multicenter trials
– Single site trials
– Pharmaceutical clinical trials
– Clinical research not involving drugs or devices

27. Sources of help
 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>

28. Negotiations
 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.

29. PHARMACEUTICAL FUNDING
Multi-center trials
 May be less lucrative than other sources of funding,
with less “wiggle room”
– 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
– Patient recruitment
– Consent form preparation
– IRB fee
– Record storage
– Investigator time

30. INVESTIGATOR INITIATED
GRANTS
 Make sure you actually
have time/resources to
do the work!

31. PHARMACEUTICAL FUNDING
Investigator Initiated
 Proposals don’t have to be drug-specific
– 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
– 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

32. SUMMARY
 Be creative
 Look for different sources of funding
 Think about what your goal is
 Don’t become a hamster in the funding
wheel!

33. Please help us
We need funds, guide us

34. Contact us:- 011-25464531, 9818569476
E-mail:- nursingnursing@yahoo.in