Robertson, David S. and Burnett, Thomas and Choodari-Oskooei, Babak and Dimairo, Munya and Grayling, Michael and Pallmann, Philip and Jaki, Thomas (2025) Confidence Intervals for Adaptive Trial Designs I: A Methodological Review. STATISTICS IN MEDICINE, 44 (18-19): e70174. ISSN 0277-6715, 1097-0258
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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 literature review of available methods, classified by the type of AD. As part of this, we assess, through a proposed traffic light system, which of several desirable features of CIs (such as achieving nominal coverage and consistency with the hypothesis test decision) each of these methods holds.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | GROUP SEQUENTIAL-TESTS; INTERIM TREATMENT SELECTION; THE-LOSERS DESIGN; CLINICAL-TRIALS; STATISTICAL-INFERENCE; CONDITIONAL ESTIMATION; UNBIASED ESTIMATION; RESAMPLING METHODS; EARLY TERMINATION; 2-STAGE DESIGNS; adaptive design; bootstrap; coverage; estimation; flexible design; group sequential; interim analyses; repeated analyses |
| Subjects: | 000 Computer science, information & general works > 004 Computer science |
| Divisions: | Informatics and Data Science > Department Machine Learning & Data Science > Lehrstuhl für Computational Statistics (Prof. Dr. Thomas Jaki) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 11 Aug 2026 07:50 |
| Last Modified: | 11 Aug 2026 07:50 |
| URI: | https://pred.uni-regensburg.de/id/eprint/67128 |
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