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Optimal weighted tests for replication studies and the two-trials rule
David S. Robertson, Thomas Jaki
Replication studies for scientific research are an important part of ensuring the reliability and integrity of experimental findings. In the context of clinical trials, the concept…
A comparison of approaches to incorporate patient-selected and patient-ranked outcomes in clinical trials
David S. Robertson, Thomas Jaki
A key aspect of patient-focused drug development is identifying and measuring outcomes that are important to patients in clinical trials. Many medical conditions affect multiple sy…
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…
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…