Multiplicity issues in clinical trials - Scientific guideline

This document addresses the multiplicity in the clinical trials in the context of an application for marketing authorisation of a medicinal product.

Keywords: Multiplicity, hypothesis test, type I error, subgroup, responder, estimation, confidence interval

Current effective version

Points to consider on multiplicity issues in clinical trials

Adopted Reference Number: CPMP/EWP/908/99 Legal effective date: 01/04/2003

Document history

Draft guideline on multiplicity issues in clinical trials

Draft: consultation closed Consultation dates: 01/04/2017 to 30/06/2017 Reference Number: EMA/CHMP/44762/2017 Summary:

This guideline is intended to provide guidance on how to deal with multiple comparison and control of type I error in the planning and statistical analysis of clinical trials. From the points to consider document published in 2002, aspects related with multiplicity issues in safety, drug-response studies, secondary endpoints, subgroup analysis and estimation were added or updated, and statistical terms were clarified.

Concept paper on the need for a guideline on multiplicity issues in clinical trials

Draft: consultation closed Consultation dates: 30/05/2012 to 30/08/2012 Reference Number: EMA/286914/2012 Summary:

The Committee for Medicinal Products for Human Use points to consider on multiplicity issues in clinical trials came into operation in 2002. This concept paper includes proposals for revisions to this guidance document, so that it can address multiplicity issues in clinical trials.