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Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: Applications and Practical Considerations

✍ Scribed by Heinz Schmidli; Frank Bretz; Amy Racine; Willi Maurer

Publisher
John Wiley and Sons
Year
2006
Tongue
English
Weight
195 KB
Volume
48
Category
Article
ISSN
0323-3847

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Confirmatory Seamless Phase II/III Clini
Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts
✍ Frank Bretz; Heinz Schmidli; Franz König; Amy Racine; Willi Maurer 📂 Article 📅 2006 🏛 John Wiley and Sons 🌐 English ⚖ 333 KB

## Abstract Traditional drug development consists of a sequence of independent trials organized in different phases. Full development typically involves (i) a learning phase II trial and (ii) one or two confirmatory phase III trial(s). For example, in the phase II trials several doses of the new co

Confirmatory Seamless Phase II/III Clini
Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: Opportunities and Limitations
✍ Christopher Jennison; Bruce W. Turnbull 📂 Article 📅 2006 🏛 John Wiley and Sons 🌐 English ⚖ 81 KB

## Abstract This is a discussion of the following two papers in this special issue on adaptive designs: ‘Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: General concepts’ by Frank Bretz, Heinz Schmidli, Franz König, Amy Racine and Willi Maurer, and ‘Confirma