Sun, Yan Wu, Wenting J. Sargent, Daniel Data from: Testing of Evaluation Bias for Progression Free Survival Endpoint in Oncology Clinical Trials Progression free survival is an increasingly popular end point in oncology clinical trials. A complete blinded independent central review (BICR) is often required by regulators in an attempt to reduce the bias in PFS assessment. In this paper, we propose a new methodology that uses a sample-based BICR as an audit tool to decide whether a complete BICR is needed. More specifically, we propose a new index, the differential risk, to measure the reading discordance pattern, and develop a corresponding hypothesis testing procedure to decide whether the bias in local evaluation is acceptable. Simulation results demonstrate that our new index is sensitive to the change of discordance pattern; type I error is well controlled in the hypothesis testing procedure, and the calculated sample size provides the desired power. progression free survival;independent review;hypothesis test;Medicine;Statistics 2016-05-05
    https://wiley.figshare.com/articles/dataset/Data_from_Testing_of_Evaluation_Bias_for_Progression_Free_Survival_Endpoint_in_Oncology_Clinical_Trials/3121840
10.6084/m9.figshare.3121840.v1