Design and analysis of stratified clinical trials in the presence of bias.

ABSTRACT:

Background

Among various design aspects, the choice of randomization procedure have to be agreed on, when planning a clinical trial stratified by center. The aim of the paper is to present a methodological approach to evaluate whether a randomization procedure mitigates the impact of bias on the test decision in clinical trial stratified by center.

Methods

We use the weighted t test to analyze the data from a clinical trial stratified by center with a two-arm parallel group design, an intended 1:1 allocation ratio, aiming to prove a superiority hypothesis with a continuous normal endpoint without interim analysis and no adaptation in the randomization process. The derivation is based on the weighted t test under misclassification, i.e. ignoring bias. An additiv

SUBMITTER: Hilgers RD 

PROVIDER: S-EPMC7270725 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature