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Activity Number: 346
Type: Topic Contributed
Date/Time: Tuesday, August 2, 2016 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #320494 View Presentation
Title: Case Study: How Promising Is the VALOR Trial for the Future of Adaptive Designs?
Author(s): Yannis Jemiai*
Companies: Cytel
Keywords: adaptive design ; promising zone ; sample size re-estimation ; unblinded ; two-stage design
Abstract:

Ever since Mehta & Pocock introduced the Promising Zone Design in 2011, there has been a great deal of interest, hope, and expectations regarding this "less well understood" design strategy. The poster child for this adaptive two-stage design with unblinded sample size re-estimation has been the VALOR study - a phase III trial evaluating the benefit-risk of Vosaroxin + Ara-C versus Ara-C alone in patients with first relapsed or refractory Acute Myeloid Leukemia. In this talk, we review the design benefits, implementation challenges, lessons learned, and opportunities for the future brought by the VALOR experience.


Authors who are presenting talks have a * after their name.

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