FDA's final rule on clinical trials

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The rule requires that certain safety information, which was previously not required to be reported to the FDA, must be reported within 15 days of becoming aware of an occurrence. These reports include:

• 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
• serious adverse events from bioavailability studies, as well as bioequivalence studies in the case of generic drugs.

The FDA has also issued a draft guidance for industry and investigators that provides information and advice about the new requirements.

“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” Rachel Behrman, Associate Director for Medical Policy in the FDA’s Center for Drug Evaluation and Research, explained in a statement. “These changes will better protect people who are enrolled in clinical trials.”

The rule also provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under the current regulations, drug sponsors often report all serious adverse events, including those that are probably not related to the product. This reporting can complicate and delay the FDA’s ability to detect safety signals. The rule clarifies when a single event should be reported and when sponsors should wait for more than one occurrence. According to the FDA, the new rule also revises definitions and reporting standards to make them more consistent with 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.

www.fda.gov