Clinical Drug Trials Face FDA Revisions
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WASHINGTON — The head of the Food and Drug Administration said Monday night the agency will revise its rules for clinical drug trials in the wake of a disastrous experiment on a hepatitis B vaccine in which five patients died.
The agency released an internal task force report that called for changes in the design, analysis and reporting of clinical studies of so-called investigational new drugs.
The agency launched its review after the deaths earlier this year of five of 15 patients taking the drug fialuridine in an experiment run by doctors from the National Institutes of Health.
FDA Commissioner David A. Kessler said the scientists missed warning signals in three earlier experiments with the drug and a related compound.
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