The FDA's new clinical vigilance

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."

Analytical pitfalls

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

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