A practical guide to simulation for an adaptive trial design with a single interim analysis.

ABSTRACT:

Background

The demand for adaptive trial designs is growing because of their flexibility and the potential for efficiency gains over traditional fixed designs. Adaptive trials allow planned modifications to the design based on accumulating data. Simulation is imperative in designing adaptive trials because analytical power formulae cannot account for data-driven adaptations. Despite their popularity, the uptake of adaptive trials has been slowed by the lack of expertise and availability of training resources.

Methods

In this tutorial, we demonstrate how to simulate data from a simple adaptive trial with a single interim analysis, summarise the simulations, and use these results to balance the type I error and power to inform the study design and to determine the expected sam

SUBMITTER: Jayawardana KS 

PROVIDER: S-EPMC12512321 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature