Unblinding at disease progression in double-blinded randomized controlled cancer drug clinical trials: A controversy requires more attention.

ABSTRACT: Unblinding at disease progression in double-blinded randomized controlled cancer drug clinical trials is ethical to the patient by ensuring optimal subsequent treatment, but the effect of study treatment on overall survival may be confounded. The views of science and ethics in this issue are controversial and the unblinding procedures should be well-designed. In real world settings, a lack of use of this unblinding process in protocol was observed in the analysis of 134 double-blind randomized controlled anticancer drug clinical trials conducted in China from 2018 to 2021. Unblinding at disease progression was allowed in only 26 (18.2%) trials. Among them, Only 9 (34.6%) trials involved patient-level unblinding. None of the 134 included trials accounted for the risk of blind-maintenance af

SUBMITTER: Dawei W 

PROVIDER: S-EPMC9792660 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature