George Y. H. Chi

TL;DR: Non‐inferiority analyses that do not involve a fixed margin are proposed that are conditionally equivalent to two confidence interval procedures that relax the conservatism of two 95 per cent confidence interval testing procedures and preserve the type I error rate at a one‐sided 0.025 level.

TL;DR: In this paper, a brief overview of some issues and some general concepts related to multiple testing problems as they are encountered in clinical drug trials is given, as well as some recent methods for handling mul...

TL;DR: The results show that a trial with endoscopies scheduled only at four month intervals is inadequate to support recurrence prevention claims; discrimination between the null and alternative hypotheses is impossible; and it is suggested that endoscopy intervals should be at most four weeks to establish a claim of ulcer prevention.

TL;DR: This paper discusses some critical topical issues of adaptive designs with supporting methodological work from either existing literature, additional technical notes, or accompanying papers, and provides numerous sources of design, conduct, analysis, and interpretation bias that arise from statistical procedures.

TL;DR: The goal was to develop some consensus among industry, government, and academic statisticians concerning requirements and methods for multiplicity management in typical clinical trials.