Confidence Intervals for Adaptive Trial Designs I: A Methodological Review.

ABSTRACT: Regulatory guidance notes the need for caution in the interpretation of confidence intervals (CIs) constructed during and after an adaptive clinical trial. Conventional CIs of the treatment effects are prone to undercoverage (as well as other undesirable properties) in many adaptive designs (ADs) because they do not take into account the potential and realized trial adaptations. This paper is the first in a two-part series that explores CIs for adaptive trials. It provides a comprehensive review of the methods to construct CIs for ADs, while the second paper illustrates how to implement these in practice and proposes a set of guidelines for trial statisticians. We describe several classes of techniques for constructing CIs for adaptive clinical trials before providing a systematic literatu

SUBMITTER: Robertson DS 

PROVIDER: S-EPMC12333484 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature