Methodological issues in confirmatory clinical trials planned with an adaptive design

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Current effective version

Reflection 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

Reflection paper

Draft reflection paper

Published: 30/04/2010

Published: 29/05/2009

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