Subjective endpoints in clinical trials: the case for blinded independent central review
Richard Walovitch,1 Bin Yao,2 Patrick Chokron,1 Helen Le,1 Glenn Bubley3
1WorldCare Clinical, LLC, Boston, MA, USA; 2Amgen, Inc, Thousand Oaks, CA, USA; 3Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA
Abstract: Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs) offer a mechanism through which to reduce assessment bias and potentially increase assessment precision and accuracy, particularly in open-label trials. An overview of regulatory agencies' rationales for an EAC is reviewed. In addition, the two main types of EACs, the blinded independent central review, and the consensus panel are compared. Selection of endpoints for EAC evaluation and design of EAC process to maximize EAC value proposition are also discussed.
Keywords: endpoint assessment committee, FDA, central review, BICR, adjudication, consensus panel
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