In oncology clinical trials, the primary endpoint of the registration studies are often Progression Free Survival (PFS), which is by nature a subjective assessment as compared to the more definitive and objective assessment of overall survival.
Regulatory agencies suggest that registration trials with subjective endpoints such as imaging could benefit from a Blinded Independent Central Review (BICR) of the clinical data. The BICR is a mechanism to eliminate bias in open labeled trials and to potentially increase accuracy and precision over site evaluation by providing better control of the review process. Process control is a major concern when dealing with a subjective and often complex assessment of imaging data, which are often the deterministic factors in PFS studies
Last date updated on July, 2014