FDA Doles Out New Rules on Clinical Trial Safety Data Reporting

Investigators will have to divulge more than previously required and in a more timely manner.

FDA has issued new rules to clarify what safety information must be reported during clinical investigation of pharmaceutical drugs and biologics. The agency now requires that certain safety information that previously was not required to be reported to FDA be handed over within 15 days of becoming aware of a safety issue.

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

FDA’s new rule also provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under current regulations, drug sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event. Such reporting complicates and delays the FDA’s ability to detect a safety signal. The examples address when a single event should be reported or when there is need to wait for more than one occurrence. 

In addition, the rule revises definitions and reporting standards so that they are more consistent with two international organizations, the International Conference on Harmonization of Technical

Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences. The changes are designed to help ensure harmonized reporting of globally conducted clinical trials.