TL48: Experiences with BICR (Blinded Independent Central Review) of Progression-Free Survival (PFS) type endpoints
*Wenting Wu, AstraZeneca 


"Time to progression (TTP) or progression-free survival (PFS) are increasingly being used as the primary endpoint for phase II/III trials in advanced disease trials in oncology. To minimize the potential bias introduced by subjectivity in radiographic interpretation, a Blinded Independent Central Review (BICR) has often been required by FDA in randomized registration trials. However, it has been noticed that some degree of disagreement at the patient level may not affect the efficacy conclusion at trial level. Is there any need for BICR? In what situation should we conduct a completed BICR? In what situation a partial BICR is acceptable? The PhRMA PFS working group report provides a guidance with respect to the application of complete vs. partial BICR in auditing.

This roundtable will focus on experiences related to use of BICR in oncology clinical trials. Specifically, three questions are posed for attendees: 1) what’s your experience in applying BICR in oncology trials? 2) Has the PhRMA PFS working group report provided any guidance in your trials? 3) What are the questions regarding BICR that has not been solved by our current research in the field? "