Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study.

ABSTRACT: Bayesian Dynamic Borrowing (BDB) designs are being increasingly used in clinical drug development. These methods offer a mathematically rigorous and robust approach to increase efficiency and strengthen evidence by integrating existing trial data into a new clinical trial. The regulatory acceptability of BDB is evolving and varies between and within regulatory agencies. This paper describes how BDB can be used to design a new randomised clinical trial including external data to supplement the planned sample size and discusses key considerations related to data re-use and BDB in drug development programs. A case-study illustrating the planning and evaluation of a BDB approach to support registration of a new medicine with the Center for Drug Evaluation in China will be presented. Key steps

SUBMITTER: Edwards D 

PROVIDER: S-EPMC10764450 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature