Clinical Trial Adverse Event Reporting To Be Discussed At FDA Public Hearing
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency announces March 21 hearing to consider the types of adverse event reports that should be submitted to institutional review boards. The proliferation of multi-center studies is one reason behind FDA’s decision to revisit the process by which IRBs assess such information.
You may also be interested in...
Adverse Events Definition Should Be Narrower, IRB Groups Tell FDA
The Consortium of Independent Review Boards favors reporting only adverse events that "probably or definitely" related to the study drug. Current regulation requires adverse events to be reported to IRBs if they are "at least possibly" related to the drug.
Lupus Guidance Suggests Broad Use Of Health-Related Quality Of Life Endpoint
FDA’s draft guidance on systemic lupus erythematosus drug development lists four possible claims that the agency “may be willing to approve”: reduction in disease activity; organ-specific lupus treatment; complete clinical response/remission; and reduction in flares.