FUNDING FOR CLINICAL RESEARCH

Jacqueline A. French MD

Professor

Department of Neurology

THINGS TO CONSIDER

What are my goals What are my interests What do I need money for

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

WHAT ARE MY GOALS?

To spend at least half of my time in academic investigation

Then:

NIH funding best bet

CAREER PLANNING

Small grants for pilot data

Career Development awards

NIH or other major funding

NIH CAREER DEVELOPMENT AWARDS

Career development award (K) Grants (R)

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

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.

K23 applications and awards FY2002

Trends in K awards by NIH institute FY 2002

NINDS K awards flat/decliningNCI K awards increasing

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

SMALL GRANTS FOR PILOT DATA

Look to internal fundinghttp://www.med.upenn.edu/research/faculty/grantscontracts.shtml

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

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.

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

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.

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

WHAT ABOUT RO1’S

What funding is available in your area? First place to look: NIH website Step # 1-find the right institute

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

WHAT ABOUT RO1’S

Step # 2-go to your granting institute website

NINDS

NINDS

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?

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

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

Smaller specialty societies– SPIN can help

Pharmaceutical– Investigator initiated– Multicenter trials– Single site trials– Pharmaceutical clinical trials– Clinical research not involving drugs or devices

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>

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.

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

INVESTIGATOR INITIATED GRANTS

Make sure you actually have time/resources to do the work!

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

SUMMARY

Be creative Look for different sources of funding Think about what your goal is Don’t become a hamster in the funding

wheel!