The impact of allocation bias on test decisions in clinical trials with multiple endpoints using multiple testing strategies.

ABSTRACT:

Background

Considering multiple endpoints in clinical trials provide a more comprehensive understanding of treatment effects and may lead to increased power or reduced sample size, which may be beneficial in rare diseases. Besides the small sample sizes, allocation bias is an issue that affects the validity of these trials. We investigate the impact of allocation bias on testing decisions in clinical trials with multiple endpoints and offer a tool for selecting an appropriate randomization procedure (RP).

Methods

We derive a model for quantifying the effect of allocation bias depending on the RP in the case of two-arm parallel group trials with continuous multiple endpoints. We focus on two approaches to analyze multiple endpoints, either the Šidák procedure to show efficacy

SUBMITTER: Schoenen S 

PROVIDER: S-EPMC11441119 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature