3 papers
stat.ME2026
Evaluating the impact of outcome delay on the efficiency of sample size re-estimation
Aritra Mukherjee, Michael J Grayling, James J M S Wason
Sample size reestimation can be a powerful tool to ensure that a clinical trial meets its prespecified power requirements when uncertainty regarding a design parameter exists at th…
stat.ME2024
Confidence intervals for adaptive trial designs II: Case study and practical guidance
David S. Robertson, Thomas Burnett, Babak Choodari-Oskooei +4
In adaptive clinical trials, the conventional confidence interval (CI) for a treatment effect is prone to undesirable properties such as undercoverage and potential inconsistency w…
stat.ME2024
Confidence intervals for adaptive trial designs I: A methodological review
David S. Robertson, Thomas Burnett, Babak Choodari-Oskooei +4
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…