BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials.

ABSTRACT:

Background

Randomized controlled trials are considered the gold standard for evaluating experimental treatments but often require large sample sizes. Single-arm trials require smaller sample sizes but are subject to bias when using historical control data for comparative inferences. This article presents a Bayesian adaptive synthetic-control design that exploits historical control data to create a hybrid of a single-arm trial and a randomized controlled trial.

Methods

The Bayesian adaptive synthetic control design has two stages. In stage 1, a prespecified number of patients are enrolled in a single arm given the experimental treatment. Based on the stage 1 data, applying propensity score matching and Bayesian posterior prediction methods, the usefulness of the historical co

SUBMITTER: Jiang L 

PROVIDER: S-EPMC10504821 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature