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Therapeutic Misdirection: An Analysis of Protocol Exception Requests in Clinical Trials

While many studies have examined the effects of therapeutic misconception on research participants, less is known about how the behavior of physician-investigators is affected. Requests for protocol exceptions submitted to the IRB at a major academic center over a three-year period were examined. These were classified into one of seven categories and analyzed based on the type of trial, the investigator, and the funding source. The results show that exceptions are frequent, are often motivated by therapeutic intent, and have the potential to adversely impact both participants and the validity of study data, leading to what we have termed therapeutic misdirection. Studies of exception requests may be an objective way to gauge the extent and impact of the physician-investigator conflict.