May 2007

Grant Results

SUMMARY

From 2000 to 2005, staff at the Institute of Medicine and the Commission on Life Sciences of the National Academies convened the Clinical Research Roundtable.

The purpose of the roundtable was to provide a forum for discussion among a wide variety of stakeholders (e.g., the academic health community, private-sector sponsors of clinical research, health plans and insurance companies) to enhance mutual understanding of and support for high-quality clinical research.

Key Results

  • The roundtable met in executive session nine times at the Washington headquarters of the National Academies. The roundtable also held two workshops and three symposiums to examine more closely issues raised at the executive sessions. Discussions focused on four key areas related to clinical research:
    • Proactively engaging the public in the conduct, oversight, outcome and translation of clinical research.
    • Developing effective information systems that support clinical research.
    • Preparing an adequately trained workforce.
    • Increasing funding for clinical research.

    The meetings included an average of 25 participants each. (For a complete listing of the most recent members of the roundtable, see Appendix 1.) They included representatives of:
    • The academic health community
    • Federal agencies sponsoring and regulating clinical research
    • Private-sector sponsors of clinical research
    • Foundations
    • Public- and private-sector insurance programs
    • Health plans and insurance companies
    • Corporate purchasers of health care
    • Representatives of patient interests

  • Project staff created a Web site containing a list and brief descriptions of the meetings and workshops, along with related reports, articles and downloadable PowerPoint® presentations. The site also includes links related to career resources for clinical researchers, resources for ethics and guidelines and related articles.

Roundtable participants published 10 articles and five reports related to topics examined at the sessions in journals such as the Journal of the American Medical Association and the Journal of Investigative Medicine. Thirty-nine articles about the roundtable appeared in periodicals, including the New York Times and Medscape Medical News.

In addition to the RWJF grant, the project also received additional funding of $1,857,500 from the roundtable sponsors, each of whom was represented by participants on the roundtable. For a list of other funders, see the Appendix 2.

After the Grant
According to the project director, many of the participants of the roundtable went on to form the Forum on Drug Discovery, Development, and Translation, based at the Institute of Medicine. The forum conducts public workshops to examine issues in drug development. Information concerning the forum is available online.

Funding
The Robert Wood Johnson Foundation (RWJF) provided partial support for this project with two unsolicited grants totaling $448,093.

 See Grant Detail & Contact Information
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GRANT DETAILS & CONTACT INFORMATION

Project

Clinical Research Roundtable

Grantee

National Academy of Sciences-Institute of Medicine (Washington,  DC)

  • Establishment of the Clinical Research Roundable
    Amount: $ 225,000
    Dates: April 2000 to June 2003
    ID#:  037805

  • Clinical Research Roundtable Meetings
    Amount: $ 223,093
    Dates: December 2002 to June 2006
    ID#:  046813

Contact

Andrew M. Pope, Ph.D.
(202) 334-1888
apope@nas.edu

Web Site

http://www.iom.edu/?ID=4881

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APPENDICES


Appendix 1

(Current as of the time of the grant; provided by the grantee organization; not verified by RWJF.)

Clinical Research Roundtable Members

Enriqueta Bond, Ph.D., Chair
President
Burroughs Wellcome Fund
Research Triangle Park, N.C.

Catherine Baase, M.D.
Global Medical Director
Dow Chemical Co.
Midland, Mich.

Robert Bonow, M.D.
President
American Heart Association
Dallas, Texas

J. Lyle Bootman, Ph.D.
Dean
Professor of Pharmacy, Medicine and Public Health
University of Arizona College of Pharmacy
Tucson, Ariz.

Robert Califf, M.D.
Director
Duke Clinical Research Unit
Duke University Medical Center
Durham, N.C.

Scott E. Campbell, Ph.D.
National Vice President
American Diabetes Association
Alexandria, Va.

Veronica Catanese, M.D.
Associate Dean
New York University School of Medicine
New York, N.Y.

Francis Chesley, M.D.
Center Director
Agency for Healthcare Research and Quality
Rockville, Md.

William Crowley, M.D.
Director of Clinical Research
Massachusetts General Hospital
Boston, Mass.

Helen B. Darling
President
National Business Group on Health
Washington, D.C.

Adrian Dobs, M.D.
Professor
Johns Hopkins University School of Medicine
Baltimore, Md.

John Feussner, M.D., M.P.H.
Professor and Chairman
Department of Medicine
Medical University of South Carolina
Charleston, S.C.

Elaine Gallin, Ph.D.
Director of Medical Research Program
Doris Duke Charitable Foundation
Hillsboro, N.J.

Myron Genel, M.D.
Associate Dean
Yale University School of Medicine
New Haven, Conn.

Kenneth Getz, M.B.A.
President
CenterWatch
Boston, Mass.

Lawrence W. Green, Dr.P.H.
Director
Office of Science and Extramural Research
Centers for Disease Control and Prevention
Atlanta, Ga.

Stephen Bennett Johnson, Ph.D.
Associate Professor
Columbia University
New York, N.Y.

Antonia Kolokathis, M.D.
Vice President
Pfizer
New York, N.Y.

Allan Korn, M.D.
Chief Medical Officer
Blue Cross/Blue Shield Association
Chicago, Ill.

David Korn, M.D.
Senior Vice President
Association of American Medical Colleges
Washington, D.C.

Jim Lando, M.D., M.P.H.
Deputy Associate Director for Science
Centers for Disease Control and Prevention
Atlanta, Ga.

David Lepay, M.D., Ph.D.
Senior Advisor for Clinical Science
Food and Drug Administration
Washington, D.C.

John R. Lumpkin, M.D., M.P.H.
Senior Vice President
Robert Wood Johnson Foundation
Princeton, N.J.

Rick Martinez, M.D.
Director of Medical Affairs
Johnson & Johnson
New Brunswick, N.J.

Richard Murray, M.D.
Vice President
Merck & Co.
Whitehouse Station, N.J.

Jonathan Perlin, M.D., Ph.D.
Chief Research and Development Officer
Department of Veterans Affairs
Washington, D.C.

Nancy E. Reame, Ph.D., R.N.
Professor of Nursing
Research Scientist
University of Michigan
Ann Arbor, Mich.

E. Albert Reece, M.D., Ph.D., M.B.A.
Vice Chancellor and Dean
University of Arkansas College of Medicine
Little Rock, Ark.

David Rimoin, M.D., Ph.D.
Chairman of Pediatrics
Cedars-Sinai Medical Center
Los Angeles, Calif.

Patricia Salber, M.D., M.B.A.
Senior Medical Director
CalPERS
Blue Shield of California
San Francisco, Calif.

David Scheinberg, M.D., Ph.D.
Chairman, Molecular Pharmacology and Chemistry
Sloan-Kettering Institute
New York, N.Y.

Bernard Schwetz, D.V.M., Ph.D.
Acting Director
Office for Human Research Protections
Senior Advisor, U.S. Food and Drug Administration
Washington, D.C.

Louis Sherwood, M.D.
President
MEDSA, LLC
Delray Beach, Fla.

Harold Slavkin, D.D.S.
Dean
University of Southern California School of Dentistry
Los Angeles, Calif.

Stephen E. Straus, M.D.
Director
National Center for Complementary and Alternative Medicine
Bethesda, Md.

Nancy Sung, Ph.D.
Program Officer
Burroughs Wellcome Fund
Research Triangle Park, N.C.

Reed Tuckson, M.D.
Senior Vice President
United Health Foundation
Minnetonka, Minn.

Sean Tunis, M.D., M.Sc.
Chief Clinical Officer and Director of the Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Washington, D.C.

Roy E. Twyman, M.D.
Senior Director
Johnson & Johnson
New Brunswick, N.J.

Frances Visco, J.D.
President
National Breast Cancer Coalition
Washington, D.C.

Susan L. Weiner, Ph.D.
President
The Children's Cause, Inc.
Silver Spring, Md.

Michael Welch, Ph.D.
Co-Director
Division of Radiological Sciences
St. Louis School of Medicine
Washington University
St. Louis, Mo.

BOARD LIAISONS
Steven Paul, M.D., Ph.D.
Group Vice President
Lilly Research Laboratories
Indianapolis, Ind.

Hugh Tilson, M.D., Dr.P.H.
Senior Advisor to the Dean
School of Public Health
University of North Carolina
Chapel Hill, N.C.


Appendix 2

(Current as of the time of the grant; provided by the grantee organization; not verified by RWJF.)

Additional Funders

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BIBLIOGRAPHY

(Current as of date of this report; as provided by grantee organization; not verified by RWJF; items not available from RWJF.)

Articles

"From the IOM's Clinical Research Roundtable." Journal of Investigative Medicine, 48(5): 307–308, 2000.

"From the IOM's Clinical Research Roundtable: Upcoming CRR Events." Journal of Investigative Medicine, 49(1): 10–11, 2001.

Genel M and Dobs A. "Translating Clinical Research into Practice: Practice-Based Research Networks-A Promising Solution." Journal of Investigative Medicine, 51(2): 64–71, 2003. Abstract available online.

Kalfoglou AL and Boenning DA. "Exploring Public Confidence in Clinical Research." Journal of Investigative Medicine, 48(6): 393–394, 2000.

Kalfoglou AL and Sung NS. "What Inspires Clinical Research Trainees and Keeps Them on the Path?" Journal of Investigative Medicine, 50(6): 408–411, 2002.

Rosenberg RN. "Translating Biomedical Research to the Bedside." Journal of the American Medical Association, 289(10): 1305–1306, 2003.

Salber PR. "The Role of Purchasers in the Clinical Research Enterprise." Journal of Investigative Medicine, 50(3): 170–172, 2002.

Schwetz BA and Dobs AS. "Streamlining the Clinical Research Enterprise." Journal of Investigative Medicine, 50(5): 356–360, 2002.

Sung NS, Crowley WF Jr., Genel M, Salber P, Sandy L, Sherwood LM, Johnson SB, Catanese V, Tilson H, Getz K, Larson EL, Scheinberg D, Reece EA, Slavkin H, Dobs A, Grebb J, Martinez RA, Korn A, and Rimoin D. "Central Challenges Facing the National Clinical Research Enterprise." Journal of the American Medical Association, 289(10): 1278–1287, 2003. Abstract available online.

Tilson H, Helms D and Dowdy D. "Improving the US Healthcare System: Action Plan to Enhance Efficiency, Reduce Errors, and Improve Quality." Journal of Investigative Medicine, 51(2): 72–78, 2003. Abstract available online.

Reports

Aungst J, Hass A, Ommaya A and Green LW (eds). Engaging the Public in the Clinical Research Enterprise. Washington: National Academies Press, 2003.

Developing the Clinical Investigator Workshop: Clinical Research Roundtable Symposium I. Washington: National Academies Press, 2001.

Exploring the Map of Clinical Research for the Coming Decade: Clinical Research Roundtable Symposium III. Washington: National Academies Press, 2000. Available online.

Public Confidence and Involvement in Clinical Research: Clinical Research Roundtable Symposium II. Washington: National Academies Press, 2000. Available online.

Tunis S, Korn A and Ommaya A (eds). The Role of Purchasers and Payers in the Clinical Research Enterprise. Washington: National Academies Press, 2002. Available online.

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Report prepared by: Robert Crum
Reviewed by: Marian Bass
Program Officer: Constance M. Pechura
Program Officer: Jeane Ann Grisso

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