Bladder, Renal Cancer Trials Should Use Blinded Independent Central Review, FDA Says
Trials of adjuvant treatments for bladder and renal cancer that use disease-free survival (DFS) as the primary endpoint should rely on a blinded independent central review (BICR) to exclude potential participants with metastatic disease, according to two draft guidances the FDA released last week.
The two guidances provide virtually identical recommendations for trial eligibility, imaging assessments, data analysis and interpretation of results. Both recommend that trials use BICR to define DFS and disease recurrence.
Interim DFS analyses are not encouraged, the guidance says, “because immature data may lead to over- or underestimation of magnitude of improvement.” However, trial protocols and statistical analysis plans should include a formal interim analysis of overall survival at the time of final DFS analysis.
Comments on the draft guidances are due by Nov. 30.
To read the bladder cancer guidance, click here: https://bit.ly/3d4Am8F.
To read the renal cancer guidance, click here: https://bit.ly/2GdaUln.