Meeting the Challenge of Appropriate Safety Report Distribution During Clinical Trials

By Kristy Fusco, MLD

A major concern in the clinical research industry is the over-reporting of expedited safety reports to investigative sites; letters notifying of new, urgent safety issues are distributed during clinical trials, even though the safety event does not meet criteria for being reported in such a manner. The volume of safety reports being sent to investigative sites is frustrating for investigators, sometimes causing them to disregard letters which may result in clinically-significant safety signals being missed in the noise of non-significant event reports, and the workload volume may even lead sites to consider ending their participation in the clinical trial. How can we ensure that investigative sites only receive the reports they truly need to review? This question must be answered in order to bring efficiency back to the review process and to ensure that investigators are spending their time where it matters most, with the study participants.