Power and sample sizes estimation in clinical trials with treatment switching in intention-to-treat analysis: a simulation study.

ABSTRACT:

Background

Treatment switching, also called crossover, is common in clinical trials because of ethical concerns or other reasons. When it occurs and the primary objective is to identify treatment effects, the most widely used intention-to-treat analysis may lead to underpowered trials. Here, we presented an approach to preview power reductions and to estimate sample sizes required to achieve the desired power when treatment switching occurs in the intention-to-treat analysis.

Methods

We proposed a simulation-based approach and developed an R package to perform power and sample sizes estimation in clinical trials with treatment switching.

Results

We simulated a number of randomized trials incorporating treatment switching and investigated the impact of the relative eff

SUBMITTER: Deng L 

PROVIDER: S-EPMC9948351 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature