A novel equivalence probability weighted power prior for using historical control data in an adaptive clinical trial design: A comparison to standard methods.

ABSTRACT: A standard two-arm randomised controlled trial usually compares an intervention to a control treatment with equal numbers of patients randomised to each treatment arm and only data from within the current trial are used to assess the treatment effect. Historical data are used when designing new trials and have recently been considered for use in the analysis when the required number of patients under a standard trial design cannot be achieved. Incorporating historical control data could lead to more efficient trials, reducing the number of controls required in the current study when the historical and current control data agree. However, when the data are inconsistent, there is potential for biased treatment effect estimates, inflated type I error and reduced power. We introduce two novel

SUBMITTER: Bennett M 

PROVIDER: S-EPMC8611797 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature