A systematic review of randomised controlled trials with adaptive and traditional group sequential designs - applications in cardiovascular clinical trials.

ABSTRACT:

Background

Trial design plays a key role in clinical trials. Traditional group sequential design has been used in cardiovascular clinical trials over decades as the trials can potentially be stopped early, therefore, it can reduce pre-planned sample size and trial resources. In contrast, trials with adoptive designs provide greater flexibility and are more efficient due to the ability to modify trial design according to the interim analysis results. In this systematic review, we aim to explore characteristics of adaptive and traditional group sequential trials in practice and to gain an understanding how these trial designs are currently being reported in cardiology.

Methods

PubMed, Embase and Cochrane Central Register of Controlled Trials database were searched from January

SUBMITTER: Zhang J 

PROVIDER: S-EPMC10483862 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature