FDA clarifies safety data required in clinical trial reporting

Today the FDA issued a new rule requiring the prompt reporting of specific safety information during clinical trials for investigational drugs and biologics, according to a press release.

“This final rule will expedite FDA’s review of clinical safety information and help the agency monitor the safety of investigational drugs and biologics,” Rachel Behrman, MD, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research, said in a press release. “These changes will better protect people who are enrolled in clinical trials.”

The new rule requires that the following information be reported within 15 days of occurrence:

findings from clinical or epidemiological studies that suggest a significant risk to study participants.
serious unsuspected adverse reactions that occur at a rate higher than expected.
serious adverse events from bioavailability studies which determine what percentage and at what rate drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug.

The ruling also includes guidelines for reporting serious adverse events, with examples for when to report single events and when to wait for more than one occurrence. Also included are revised definitions and reporting standards that better adhere to those of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and WHO’s Council for International Organizations of Medical Sciences.

Information and advice on the new requirements are available in an FDA draft for industry and investigators.

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