Current
Proposals to expand the existing federal clinical drug trials database
to include results from all clinical trials, regardless of the source
of funding for the trial, has been included in broader drug safety
legislation in both the House and Senate. On February 1, Senators
Mike Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) introduced the "Enhancing
Drug Safety and Innovation Act of 2007" (S. 484), which included
clinical trials database provisions as Title III. S. 484, in turn,
was amended and included in the "Food and Drug Administration
Revitalization Act" (S. 1082), which the Senate passed on May
9. The House version of S. 484 was introduced on March 19 as H.R.
1561 by Representatives Henry Waxman (D-Calif.) and Edward Markey
(D-Mass.). H.R. 1561 still awaits action in the House Energy and
Commerce Committee.
The Senate bill expands the purview of the National Library of
Medicine's existing ClinicalTrials.gov registry to include clinical
trials for medical devices as well as drugs, and to include links
to publicly available results information. The House bill establishes
a new database to register clinical trials for medical devices and
drugs, and a separate database for results information. Both bills
require that the registry's content conform to the data set of the
World Health Organization, and that entries in the database be searchable
by the public according to a set of specified criteria.
|
 |
AAMC Documents
|
