On Use of Covariates in Randomization and Analysis of Clinical Trials

Le résumé fourni par la source

Randomization provides the basis for determining causality in scientific experiments. While there are settings in medicine and public health where convincing evidence may be obtained from non-randomized studies, there is a clear shift toward requiring higher-quality evidence obtained from well-designed randomized trials. Rapidly changing diagnostic and disease assessment tools, use of more subjective endpoints, requirements for diverse patient populations and modest effect sizes all tend to weaken the inference from uncontrolled experiments. In oncology, where historically a single-arm phase II trial has often been adequately informative, randomized phase II trials are becoming increasingly common.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.