Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding

This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a sm...

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Bibliographic Details
Main Authors: Jiacheng Yuan, Daniel Radecki, Denise Bugarin, Till Geib, Jihao Zhou, Jeen Liu
Format: Article
Language:English
Published: Elsevier 2018-09-01
Series:Contemporary Clinical Trials Communications
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865417301977