The Cox Model With Adaptive Fused Group Bridge Penalty to Incorporate Historical Data Into the Analysis of Clinical Trials With an Application to BMT CTN 1101.

ABSTRACT: The incorporation of historical data (HD) into a clinical trial analysis can improve the precision and efficiency of treatment evaluation if the HD are exchangeable with clinical trial data. Evaluating the exchangeability of these two data sets is challenging, however, as an incorrect assessment of exchangeability yields invalid inference on the treatment effect that may produce bias and inflate the Type I error rate. To address this practical problem, we propose an adaptive fused group bridge penalty to evaluate the comparability of parameters between HD and clinical trial data and make inferences on the treatment effect. The proposed penalty has oracle properties, including consistency for identifying the underlying model and the asymptotic normality of the estimators. Simulation studies

SUBMITTER: Fang X 

PROVIDER: S-EPMC12614236 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature