Clinical trials in small populations

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Current effective version

Adopted guideline

Reference numberCHMP/EWP/83561/05
Published27/07/2006
Effective from01/02/2007
KeywordsSmall population, sample size, surrogate endpoint, patient registry, external control, noise-to-effect ratio, randomisation, control group, matching, stratification, case series, case reports
DescriptionThis document addresses problems associated with clinical trials when there are limited numbers of patients available to study.


Document history

First version

Current version

Adopted guideline


Overview of comments

In operation: 01/02/2007–present


Published: 27/07/2006


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