Simulation studies conducted in collaboration with with Dr. Fenghai Duan, assistant professor with the Department of Biostatistics and Center for Statistical Science at Brown University, demonstrate that small changes in reader precision and accuracy can result in decreased trial sample size and ultimately trial costs.
WCC believes that the results from its study can be applied to any BICR involving subjective clinical data. Our approach is the same for all BICRs - we leverage our relationship with Harvard and other leading teaching hospitals, allowing us to draw from the best subspecialty-trained, board-certified practicing physicians, who are then trained by WCC under a uniform system to maximize the precision and accuracy of data interpretation.
The FDA’s 2011 Draft Guidance Standard for Clinical Trial Imaging Endpoints states that a blinded independent central review (BICR) is often needed in situations where clinical site image interpretation is variable and results of image measurements are important for eligibility determination, safety and/or efficacy endpoints.
“…the centralized process can better provide verifiable and uniform reader training as well as ongoing management of reader performance, ensuring that the process is accurate and that bias and variability are minimized…”
Whether your trial requires a single radiologist with a single modality, a double-blind read with adjudication and multiple modalities, or simply an image management platform, WorldPRO® can be configured to meet your specific needs. Complex workflows also support technical pre-measurement and EAC reviews, without requiring special hardware or in-depth training.