Pharmacometrics enhanced Bayesian borrowing approach to improve clinical trial efficiency: Case of empagliflozin in type 2 diabetes.

ABSTRACT: We report use of a pharmacometrics enhanced Bayesian borrowing (PEBB) approach to leverage historical clinical trial data on a drug product to build models, project the outcome of future clinical trials, and borrow information from these projections to improve the efficiency of future target trials. This design takes a two-stage approach. First, a design phase is performed before target trial data are available to determine the operating characteristics and an appropriate tuning parameter that will be used in the subsequent analysis phase of a chosen target trial. Second, once the target trial data are available, the analysis phase is performed with the determined tuning parameter. This step is where borrowing is applied from these projections to inform the results for the target trial. To

SUBMITTER: Fayette L 

PROVIDER: S-EPMC10583245 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature