Journal of Clinical Trials
Open Access

Abstract

Monitoring Reader Metrics in Blinded Independent Central Review of Oncology Studies

Kristin L Cohen, Mithat Gönen and Robert R Ford

Purpose: Blinded independent central review (BICR) is advocated by regulatory authorities as a means of minimizing bias and independently verifying endpoints based on medical imaging when the data is intended to support pivotal trials. However, discordance between reviewers at the BICR raises concern with regulators. There are few published metrics related to discordance rates at the BICR and there is currently no standard metric which can be used to monitor reviewer performance in the BICR setting. Methods: We analyzed BICR data from 29 oncology clinical trials including interpretations by 24 different radiologist reviewers of over 12,000 subject cases. Results: The average reader acceptance rate was 48% and the rejection rate was 52%. Conclusion: Based on our analysis, we propose the use of p-charts to monitor reviewer performance in oncology clinical trials employing BICR.