The Food and Drug Administration (FDA) issued a new rule this week that will clarify what and when safety information must be reported during clinical trials of investigational drugs and biologics.
The new rule, which goes into effect on March 28, 2011, replaces current practices of reporting any and all adverse reactions experienced a during clinical trials once the trial is complete. The new rule requires companies sponsoring new drugs or medical products to report within 15 days any safety issues, such as findings that suggest a significant risk to study participants and higher-than-expected adverse events to the treatments.
The new rule also lifts the requirement for drug companies to report all serious adverse events, such as events that had to do with underlying disease and not the drug itself. The FDA instead is offering guidelines on when a single event needs to be reported.
The rule also requires safety information be reported on serious adverse events from bioavailability studies, which determine what percentage and at what rate the drug is absorbed by the bloodstream, as well as bioequivalence studies, which determine whether a generic drug has the same bioavailability as the brand name drug.
“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” said Rachel Behrman, M.D, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. “These changes will better protect people who are enrolled in clinical trials.”
According to the FDA, the new 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.