A two-stage design for phase II trials with time-to-event endpoint using restricted follow-up

In phase II oncology trials, the use of new cytostatic drugs raises some questions regarding the endpoint. Time-to-event endpoints such as Progression-Free Survival have been recommended and led to new designs. In 2003, Case and Morgan proposed a design based on the comparison of the cumulative haza...

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Bibliographic Details
Main Authors: Lisa Belin, Yann De Rycke, Philippe Broët
Format: Article
Language:English
Published: Elsevier 2017-12-01
Series:Contemporary Clinical Trials Communications
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865417300753