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National Library of Medicine
Board of Regents
Working Group on Clinical Trials

At its September 2007 meeting, the National Library of Medicine’s Board of Regents authorized its Chair to appoint a Working Group on Clinical Trials to assist NLM in meeting new responsibilities for clinical trials registration and results reporting under recent Congressional legislation [enacted as Public Law 110-85]. NLM has primary responsibility for implementing the expanded clinical trials registry and results database that is outlined in the Law. This work will build on the existing ClinicalTrials.gov system that was launched in February 2000 and as of February 2008 contained information on more than 50,000 clinical studies conducted in more than 150 countries.

The first meeting of the Working Group was scheduled for Monday, February 11, 2008, immediately preceding the scheduled meeting of the NLM Board of Regents on February 12-13, 2008. The charge to the Working Group and its membership are presented below.

Working Group Charge

The NLM Board of Regents Working Group on Clinical Trials Reporting will advise the NLM Board of Regents on issues associated with the expansion of Clinicaltrials.gov and the addition of a results database. It will advise the Board on how best the NLM can respond to new legislative mandates regarding clinical trials information, in particular those contained in Public Law 110-85. The Working Group’s most important tasks will be to determine if NLM is doing the best job possible in carrying out the new mandates, provide whatever advice it finds appropriate, and report it conclusions.

The Working Group will meet at least twice per year and report its findings, with any recommendations, to the NLM Board of Regents.

Membership

Cynthia Morton, PhD* (Chair)
Brigham & Women's Hospital

Thomas Bradley, JD
Attorney General's Office for the State of Maine

Rob Califf, MD***
Duke University Medical Center

Jordan Cohen, MD**
George Washington University

Sherrilynne Fuller, PhD
University of Washington

R. Brian Haynes, MD
McMaster University

Donald Kennedy, PhD
Stanford University

Richard Kuntz, MD
Medtronic, Inc.

Barbara McNeil, MD, PhD
Harvard Medical School

James Powell, MD
National Medical Association, (formerly) Proctor & Gamble

Frank Rockhold, PhD
GlaxoSmithKline

Louis Rossiter, PhD**
The College of William & Mary

Myrl Weinberg
National Health Council

Alastair Wood, MD
Symphony Capital

*Chair of the NLM Board of Regents
**Member of the NLM Board of Regents
***Member of NLM Lister Hill National Center for Biomedical Communications Board of Scientific Counselors