Methodological issues in confirmatory clinical trials planned with an adaptive design

Current effective version

PDF iconReflection paper

Reference numberCHMP/EWP/2459/02
KeywordsAdaptive design, interim analyses, design modifications, randomised clinical trials, Confirmatory clinical trials, biostatistics
DescriptionThis document focuses on the opportunities for interim trial design modifications, and the prerequisites, problems and pitfalls that must be considered as soon as any kind of flexibility is introduced into a confirmatory clinical trial intended to provide evidence of efficacy.

Document history

First version

Current version

PDF iconReflection paper


PDF iconDraft reflection paper

Published: 30/04/2010


Published: 29/05/2009

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