Author: Jon Merz
Date: 07-09-04 11:51
Source: NY Times
URL: http://nytimes.com/2004/07/09/politics/09drug.html
Date published: July 9th 2004
3 Senators Seeking Details for a Drug-Trial Database
By BARRY MEIER
Published: July 9, 2004
Three Democratic senators who have already expressed interest in creating a required database of clinical drug trials asked federal regulators yesterday to outline what additional financing and enforcement mechanisms would be needed to create such a database.
The three - Senators Tim Johnson of South Dakota, Edward M. Kennedy of Massachusetts and Christopher J. Dodd of Connecticut - made the request in a letter sent to the heads of the Food and Drug Administration and the National Institutes of Health.
In the letter, the senators asked what could be done to either improve an existing government-run database, expand it or create a new one, so that drug makers would be required to post both the existence of a drug trial and its results.
The existing database, which is called ClinicalTrials.gov, is limited and essentially functions as an information resource for people who are looking to take part in trials of new drugs aimed at serious or life-threatening diseases.
However, many drug makers do not list all their tests in the registry, and there is no requirement for manufacturers to post the results of the trials.
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