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CBER Plan Aims to Speed AE Analysis, Reduce Phase III Failures

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FDA’s Center for Biologics Evaluation and Research (CBER) hopes to speed studies of biologic adverse events within the next five years by using the FDA’s Mini-Sentinel postmarket surveillance pilot in partnership with other government agencies and private organizations.

The move, one of a number of regulatory science updates the center hopes to implement over the next five years, is outlined in its new strategic plan for regulatory science and research.

CBER officials point out that many biologic products fail in Phase III testing. They say the center needs new tests and biomarkers to better predict clinical performance and prevent late-stage failures.

AEs Can Be Hard to Spot

CBER wants to pool larger data sets to better spot adverse events caused by biologics — events that may occur infrequently in small clinical trials.

One problem is that even when unexpected events occur, it may be unclear whether they should be classified as adverse events.

Most investigators agree — when it comes to labeling unexpected events during a clinical trial, the answer isn’t always obvious. The definitions — and the required responses — vary from one agency to the next.

And the reporting process only adds more stress. Misjudge a problem and you’ll pay a steep price for failure to report to the FDA.

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