Expected Value of Sample Information to Guide the Design of Group Sequential Clinical Trials.

ABSTRACT:

Introduction

Adaptive designs allow changes to an ongoing trial based on prespecified early examinations of accrued data. Opportunities are potentially being missed to incorporate health economic considerations into the design of these studies.

Methods

We describe how to estimate the expected value of sample information for group sequential design adaptive trials. We operationalize this approach in a hypothetical case study using data from a pilot trial. We report the expected value of sample information and expected net benefit of sampling results for 5 design options for the future full-scale trial including the fixed-sample-size design and the group sequential design using either the Pocock stopping rule or the O'Brien-Fleming stopping rule with 2 or 5 analyses. We consid

SUBMITTER: Flight L 

PROVIDER: S-EPMC9005835 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature