IRBs are Overloaded with Adverse Events

According to this post on outsourcing-pharma.com, the rising number of adverse events reported to institutional review boards is hindering clinical trials from protecting their patients. To alleviate this problem the Food and Drug Administration is recommending that all event information should be forwarded to the clinical trial’s sponsor first for initial analysis, if an “unanticipated problem” is detected, then it should be sent to an IRB. This as well as a lack of understanding of what adverse events should be classed as an “unanticipated problem” is adding to the problem.

International sponsors should be fully trained on what event information should be sent to IRBs in order to simplify this matter.