Investigation of subgroups in confirmatory clinical trials - Scientific guideline
Table of contents
This document provides guidance for assessors in European regulatory agencies on assessment of subgroup analyses in confirmatory clinical trials. It should also be useful to clinical trial sponsors and to assessors engaged in providing scientific advice.
Keywords: Subgroup analysis, confirmatory clinical trials, randomised controlled trials, internal consistency, heterogeneity, biostatistics, assessment of clinical trials, analysis plan, exploratory analysis, benefit/risk assessment
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Guideline on the investigation of subgroups in confirmatory clinical trials (PDF/337.61 KB)
Adopted
First published: 14/03/2019
Legal effective date: 01/08/2019
EMA/CHMP/539146/2013 -
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Draft guideline on the investigation of subgroups in confirmatory clinical trials (PDF/454.59 KB)
Draft: consultation closed
First published: 03/02/2014
Last updated: 03/02/2014
Consultation dates: 03/02/2014 to 31/07/2014
EMA/CHMP/539146/2013 -
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Concept paper on the need for a guideline on the use of subgroup analyses in randomised controlled trials (PDF/72.09 KB)
Draft: consultation closed
First published: 30/04/2010
Last updated: 30/04/2010
Consultation dates: 22/04/2010 to 31/07/2010
EMA/CHMP/EWP/117211/2010
- Biostatistics
- Guideline on summary of product characteristic
Need for a guideline on the use of subgroup analyses in randomised controlled trials- Adjustment for baseline covariates in clinical trials
- Application with 1. Meta-analyses; 2. One pivotal study
- ICH E9 Statistical principles for clinical trials
- Multiplicity issues in clinical trials