Ontology highlight
ABSTRACT:
SUBMITTER: Edwards D
PROVIDER: S-EPMC10764450 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
Edwards Dawn D Best N N Crawford J J Zi L L Shelton C C Fowler A A
Therapeutic innovation & regulatory science 20231101 1
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 pl ...[more]