Implementation of the final rule expands the safety information that must be submitted within 15 days of an issue arising. The US Food and Drug Administration (FDA) believes the changes will expedite its review of critical safety information and better protect clinical trial participants.
In a final rule and accompanying draft guidance the FDA states sponsors must now report: findings from clinical or epidemiological studies that suggest a significant risk to trial participants; and serious suspected adverse reactions that occur at a rate higher than expected.
Serious adverse events that occur during bioavailability and generic bioequivalence studies must also be reported within 15 days of the issue arising. Unexpected fatal or life-threatening suspected adverse reactions must be reported to the FDA within seven calendar days.
Clarify and harmonise
Unnecessary reporting of perceived adverse events is a drain on resources for the FDA, investigators and institutional review boards (IRBs). Having recognised some common mistakes in reporting adverse events the FDA has clarified its position.
In its documentation the FDA addresses when a single event should be reported and when sponsors should wait until a number of similar events have occurred.
Unnecessary reports of individual serious adverse events include: experiences that were probably linked to the underlying disease; issues that commonly occur in the study population independent of drug exposure; and those that were study endpoints.
Finally, revisions to definitions and reporting standards have been made to make them more consistent with the International Conference on Harmonization (ICH) and World Health Organization (WHO). This ensures harmonised reporting of globally conducted clinical trials.