JSM Preliminary Online Program
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Activity Number: 54
Type: Topic Contributed
Date/Time: Sunday, August 2, 2009 : 4:00 PM to 5:50 PM
Sponsor: Biometrics Section
Abstract - #304681
Title: Current Issues in Oncology Drug Development, with a Focus on Phase II Trials
Author(s): Terry Hyslop*+ and Daniel Sargent and Jeremy Taylor
Companies: Thomas Jefferson University and Mayo Clinic and University of Michigan
Address: , , 19107,
Keywords: clinical trials ; oncology ; early drug development
Abstract:

The standard paradigm for the evaluation of new agents for the treatment of cancer is a phase I trial to establish the dose, a phase II trial to obtain preliminary evidence of efficacy; and a phase III trial to compare with a standard therapy. In this approach phases I and II are for gathering information, phase III is for a definitive comparison. These three phases of development represent an idealized scenario. More recently, it has been recognized that it is not necessarily desirable to force a uniform approach that ignores the scientific context of the disease and the experimental agent. The current interest in adaptive designs, seamless Phase II/III studies, Phase I trials with an expansion phase, phase, and Phase I/II trials suggest that the clinical trial community is exploring a variety of approaches beyond the simple compartmentalization of phase I, II, and III.

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