Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation.

ABSTRACT:

Background

Group sequential designs are one of the most widely used methodologies for adaptive design in randomized clinical trials. In settings where early outcomes are available, they offer large gains in efficiency compared to a fixed design. However, such designs are underused and used predominantly in therapeutic areas where there is expertise and experience in implementation. One barrier to their greater use is the requirement to undertake simulation studies at the planning stage that require considerable knowledge, coding experience and additional costs. Based on some modest assumptions about the likely patterns of recruitment and the covariance structure of the outcomes, some simple analytic expressions are presented that negate the need to undertake simulations.

Methods

SUBMITTER: Parsons NR 

PROVIDER: S-EPMC10870612 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature