Clinical trials in small populations - Scientific guideline
Table of contents
This document addresses problems associated with clinical trials when there are limited numbers of patients available to study.
Keywords: Small population, sample size, surrogate endpoint, patient registry, external control, noise-to-effect ratio, randomisation, control group, matching, stratification, case series, case reports
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Guideline on clinical trials in small populations (PDF/63.59 KB)
Adopted
First published: 27/07/2006
Last updated: 27/07/2006
Legal effective date: 01/02/2007
CHMP/EWP/83561/2005 -
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Overview of comments received on draft guideline 'clinical trials in small populations' (PDF/86.74 KB)
First published: 27/07/2006
Last updated: 27/07/2006
EMEA/CHMP/EWP/281490/2006
- Biostatistics
- Scientific guidelines: paediatrics
- Directive 2001/83/EC
Calculation and reporting of the prevalence of a condition for orphan designation- Note for sponsors of orphan medicinal products regarding enlargement of the European Union
- Application with 1. Meta-analyses; 2. One pivotal study
- Clinical evaluation of diagnostic agents
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety
- ICH E4 Dose response information to support drug registration
- ICH E8 General considerations for clinical trials
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH E11 Clinical investigation of medicinal products in the paediatric population
- Methodological issues in confirmatory clinical trials planned with an adaptive design