While current guidelines generally recommend single endpoints for primary analyses of
confirmatory clinical trials, it is recognized that certain settings require inference on multiple …

Adaptive clinical trials are the cornerstone of modern drug and device development. The
most recent US legislation calls for higher efficiency in designing clinical trials with emphasis …

Multi‐arm group sequential clinical trials are efficient designs to compare multiple treatments
to a control. They allow one to test for treatment effects already in interim analyses and can …

The problem of testing multiple hypotheses using a group sequential procedure often arises
in clinical trials. We review several group sequential Holm (GSHM) type procedures …

We consider a confirmatory clinical trial where a primary and a secondary endpoints are
tested hierarchically to control the family-wise error rate at level α. The trial uses a group …

In this chapter, we give a survey of multiple test procedures (MTPs) based on p-values.
These MTPs are widely used in practice since they are easy to apply and do not make any …

Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates
on the biostatistics component of clinical trials. This new edition is updated throughout and …

Group sequential design (GSD) is widely used in clinical trials in which correlated tests of
multiple hypotheses are used. Multiple primary objectives resulting in tests with known …

Maurer and Bretz developed a class of group-sequential weighted Bonferroni procedures
with multiple endpoints. Performed as a step-down consonant shortcut to the group …

We consider multistage tests of multiple hypotheses under a flexible setting of calendar time
and information fraction, focusing on the case where there are two hypotheses under testing …