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Adaptive Trial Paper Explores Benefits of Adaptive Trials for Phase I, Phase II Studies
Date:2/2/2010

Adaptive trial design is a hot topic in the drug development community thanks to their complexity and substantial potential benefits for sponsors and patients. In Medelis' new issue of Peer Perspectives in Oncology, Dr. Ranganath Nayak of Cytel Inc. discusses the rapid evolution of the adaptive trial model and the latest thinking about its application in phase I and phase II clinical studies.

Phoenix AZ (PRWEB) February 2, 2010 -- Adaptive trial design is a hot topic in the drug development community thanks to their complexity and substantial potential benefits for sponsors and patients. In Medelis' new issue of Peer Perspectives in Oncology, Dr. Ranganath Nayak of Cytel Inc. discusses the rapid evolution of the adaptive trial model and the latest thinking about its application in phase I and phase II clinical studies.

"When the industry started seriously talking about adaptive trial design a few years back, the focus was on phase III and seamless phase II/III trials," explains Medelis CEO Bob Bosserman. "But it turns out that the real action today is in phase II dose-finding trials and even in phase I trials for safety.

"Cytel has designed more adaptive trials for industry sponsors than any other service provider and in virtually every therapeutic area," he continued. "Sponsors should carefully consider the adaptive model for the many commercial, ethical, and budgetary benefits that the paper explores."

In the interview, Dr. Nayak, the CEO of Cytel, explains why adaptive trial design is gaining so much
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