Final Adverse Event Guidance Recommends Aggregate Analysis

January 21, 2009
A final FDA guidance designed to curb unnecessary reporting of adverse events recommends that sponsors of multicenter clinical trials determine when an incident is serious, unanticipated and should be reported to an investigational review board. The guidance clarifies when an adverse event might require modification of the study protocol. It recommends using an aggregate analysis of similar events to determine whether an adverse event is anticipated.
Washington Drug Letter