Each committee is sourced from board-certified experts from MGH, who have a range of experience in subspecialties, such as radiology, dermatology, oncology, cardiology, and neurology. They are able to perform blinded independent assessments and are trained by WCC to maximize the precision and accuracy of data interpretation and minimize variability.
The process starts with charter development, which includes decision algorithms for response assessment. A workload and time assessment that incorporates training and testing programs is created in conjunction with the sponsor and EAC chair.
By allocating roles and responsibilities for each member and their specialty, we ensure the highest level of validity of efficacy results. It also allows us to maintain comprehensive coverage and verify objectivity in a streamlined assessment process. We control read statistics and provide the necessary adjudication for consistent results. These statistics are fully available to the sponsor.
As the size and complexity of registration trials increases, the challenges involved in managing digital EACs also increase proportionately. Electronic systems become essential to successfully collect, organize and present data for independent reviewers (IRs) in a regulatory-controlled environment. The EAC data, including clinical patient data, medical images, pathology slides, and other test results must be funnelled into a coherent central archive. A digital BICR process allows for multiple concurrent independent assessments of data followed by an adjudication triggered programmatically, if needed. Because it consists of multiple independent assessments, inter-reader variability can be analyzed and thus provide a better understanding of differences in interpretation strategies between EAC members.