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The FDA's new clinical vigilance
Monday, November 22, 1993
WASHINGTON - Biotechnology companies and clinical researchers say they will not be burdened by an FDA task force's recommendation for more rigorous clinical trial procedures in an attempt to prevent clinical surprises of the kind that dogged the FIAU disaster.
The task force last week recommended the series of regulations after an Eli Lilly and Co. Phase II trial of the FIAU (fialuridine) nucleoside analog caused a series of serious adverse events, including the deaths of 5 of 15 patients enrolled in the trial. Lilly licensed FIAU from Oclassen Pharmaceuticals Inc. as a treatment of chronic hepatitis B.
The task force said its recommendations were intended to "improve the likelihood of detecting, as early as possible, important drug toxicity and thereby reduce the likelihood of a recurrence of the events of the (FIAU) study."
The panel advocated procedures to address specific pitfalls in the clinical process that were suggested by the FIAU post mortem. In particular, the panel found that the FIAU trial sponsors might have anticipated the adverse events if they had properly analyzed data that was available at the start of the study.
The 80-page study also determined that sponsors may have failed to anticipate adverse reactions because FIAU's "toxicity mimicked both the subjects' underlying diseases and the toxicity caused by other medications taken by the subjects."
In addition, the task force found that "clinically observed hepatic and pancreatic toxicity in the test population was frequently delayed until weeks or months after the last dose of study drug," making it "more reasonable" to attribute the toxicity to other drugs or to underlying disease processes.
The panel also determined that each new adverse event in the FIAU trial appeared to have been considered separately, without a cumulative analysis of patient deaths and serious adverse experiences with a systematic consideration of the "worst case" that the drug being tested caused the toxicity.
FDA's Center for Drug Evaluation and Research is drafting a set of proposed regulations that will be the same as the task force recommendations, said FDA spokesperson June Wyman. The draft regulations will be published in the Federal Register, perhaps before the end of the year, she said. Final regulations will be published in the Federal Register after a 60 to 90-day public comment period.
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