Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues.
The ideal approach for the design and analysis of clinical trials is to select a single primary endpoint that provides a complete characterization of the disease under study and permits an efficient evaluation of the effect of a test drug. However, this is often not possible for a number of diseases or clinical trials. This paper examines some practical clinical decision-making scenarios for the selection and analysis of efficacy outcome measures in clinical trials with inherent multiplicity components.
D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D003657:Decision Making; D004358:Drug Therapy; D006801:Humans; D015233:Models, Statistical; D017063:Outcome Assessment, Health Care / Q000379:methods*; D012107:Research Design; D016896:Treatment Outcome