Primary efficacy and safety endpoints are often subjective assessments made by site personnel. For international registration trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can result in a loss of precision and accuracy. Centralized endpoint adjudication committees (EACs) offer a mechanism to remove treatment bias in open labeled trials and potentially increase the precision and accuracy of the assessment.
While no specific FDA guidance documents have been issued regarding the use of EACs and blinded independent central reviews (BICRs), WCC, in collaboration with Drs. Glenn Bubley, associate professor of medicine at Harvard Medical School and director of genitourinary oncology at Beth Israel Deaconess Medical Center, and Bin Yao, director of biostatistics at Amgen has published a review article which can be used as a process map for perform a central assessment of non-imaging clinical data, Read More...
We recommend that when clinical site data interpretation is variable and results of measurements are important to trial success, a BICR can provide consistent results through verifiable and uniform reader training as well as ongoing management of reader performance. The flow diagram below shows a decision tree for considering the use of an EAC.
Our process includes a set of module components that include hand picking top experts as committee members, planning the control schema for the assessment and providing fully digital evaluations.Learn More
All phases of a trial can benefit from an EAC, from eligibility and on-study determination of safety and efficacy to overall patient status. Most of our EACs consist of sophisticated, fully digital evaluations using multiple BICRs rather than the panel review approach.Learn More