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July
27,
2004 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. |
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