Reporting and communication of sample size calculations in adaptive clinical trials: a review of trial protocols and grant applications.

ABSTRACT:

Background

An adaptive design allows modifying the design based on accumulated data while maintaining trial validity and integrity. The final sample size may be unknown when designing an adaptive trial. It is therefore important to consider what sample size is used in the planning of the study and how that is communicated to add transparency to the understanding of the trial design and facilitate robust planning. In this paper, we reviewed trial protocols and grant applications on the sample size reporting for randomised adaptive trials.

Method

We searched protocols of randomised trials with comparative objectives on ClinicalTrials.gov (01/01/2010 to 31/12/2022). Contemporary eligible grant applications accessed from UK publicly funded researchers were also included. Suitabl

SUBMITTER: Zhang Q 

PROVIDER: S-EPMC11430544 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature