Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without
compromising the validity of conclusions and it is essential to distinguish pre-planned from …

To reduce a clinical trial's cost and ethical risk to its enrollees, some oncology trial designers
have suggested borrowing information from similar but already completed trials to reduce …

Background In clinical trials with fixed study designs, statistical inference is only made when
the trial is completed. In contrast, group sequential designs allow an early stopping of the …

Designs incorporating more than one endpoint have become popular in drug development.
One of such designs allows for incorporation of short‐term information in an interim analysis …

Background Standard futility analyses designed for a proportional hazards setting may have
serious drawbacks when non-proportional hazards are present. One important type of non …

In clinical trials with time‐to‐event data, the evaluation of treatment efficacy can be a long
and complex process, especially when considering long‐term primary endpoints. Using …

This article discusses futility analyses for the MCP-Mod methodology. Formulas are derived
for calculating predictive and conditional power for MCP-Mod, which also cover the case …

Introduction Most literature on optimal group-sequential designs focuses on minimising the
expected sample size. We highlight other factors for consideration. Methods We discuss …

In late 2019, the US FDA updated a new Guidance for Industry on Adaptive Designs for
Clinical Trials of Drugs and Biologics. The guideline encourages developing and …

We discuss using prediction as a flexible and practical approach for monitoring futility in
clinical trials with two co-primary endpoints (CPE). This approach is appealing in that it …