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HABIT

July 27, 2004

Vol. 7 No. 7

CONGRESS PUSHES FOR MORE COMPLETE CLINICAL DATABASE

Three weeks after the American Medical Association adopted a resolution calling for a nationwide database of all clinical trials, three members of Congress have taken up the cause and are contemplating a bill to establish the new database.

On July 9, Sens. Edward Kennedy, D-Mass., Christopher Dodd, D-Conn., and Tim Johnson, D-S.D., asked the heads of the Food and Drug Administration and the National Institutes of Health to determine what kind of financial and enforcement support it would take to make the database a reality.

Interest in a complete and open record of clinical trials stems in part from recent media reports that some antidepressant drugs may be ineffective when prescribed for children, a result shown in pharmaceutical company studies that had not been previously released. At its annual meeting in June, the AMA recommended that the Department of Health and Human Services establish a database where drug companies would be required to deposit information on all clinical trials, including those with negative results as in the antidepressant studies.

The International Committee of Medical Journal Editors, a group of 12 medical journals including the New England Journal of Medicine and the Lancet, is also considering whether researchers should be required to deposit their findings in such a database as a contingency of publication.

NIH Director Elias Zerhouni, M.D., said he supports the idea of a national clinical trials database and that the likelihood was “very high” that the government would require full participation by the drug companies.

To read the AMA’s full report on funding and pharmaceutical research, go here. To read the ICMJE guidelines on publication, go to here.

 
 

 
July 27, 2004

Vol. 7 No. 7

Greetings
HHS Announces 10-Year Plan for Health IT

Congress Pushes For More Complete Clinical Database

IOM Reports: Measuring Health in the
Young and Old
HHS Limits Government Researchers at AIDS Conference

NIMH and the “Decade of Translation”

Washington Update
Spotlight on Resources
Health and Behavior in the News
Past Issues
Announcements
Funding
Calls for Submissions/Nominatitons
Conferences and Events
Career Opportunities
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