SynthesisStatistics in medicine2025
Confidence Intervals for Adaptive Trial Designs I: A Methodological Review.
Synthesis in Statistics in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Conditional Estimations for Seamless Phase II/III Clinical Trials Involving Multi-Stage Early Stopping.Statistics in medicine · 2026Article
- Decision on Optimal Combinatorial Therapies in Immune-mediated inflammatory diseases using Systems approaches (DocTIS): protocol for a single-arm, adaptive basket trial in rheumatoid and psoriatic arthritis.Rheumatology advances in practice · 2026Article
- Confidence Intervals for Adaptive Trial Designs II: Case Study and Practical Guidance.Statistics in medicine · 2025Review
- A Fast, Flexible Simulation Framework for Bayesian Adaptive Designs-The R Package BATSS.Pharmaceutical statisticsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
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 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.