American Statistical Association
Early phase trials have evolved by including several dose-expansion cohorts that enable investigators to identify potentially effective drugs, for specific patient populations, in a single trial by assessing anti-tumor activity as early as possible. Under the old paradigm, investigational drugs were tested in a phase I trial with a small, heterogeneous patient population, to identify a safe dose before moving into disease-specific, phase II testing, where antitumor activity was assessed. This paradigm works well when few drugs are available for testing at any given time; however, technological advances have enabled numerous promising compounds to be identified that all need to be tested expeditiously in clinical trials. Moreover, molecular testing has enabled clinical investigators to potentially increase clinical benefits for specific patient subgroups, based on molecular characteristics. These changes have stimulated the need to assess antitumor activity as early as possible, resulting in the emergence of phase I trials with larger patient populations, which are designed to obtain preliminary evidence of efficacy as well as safety. The challenge is how to best identify which drugs work, at which dose, and in which patient populations, while using minimal resources.
In this talk, I will discuss how the objectives, design, and interpretation of early phase trials have evolved over time and how dose-expansion cohorts and basket trials are changing the landscape of early drug development. Particular focus will be paid to the protocol review and approval process of adaptive trials and how protocol amendments are challenging the conduct and interpretation of such trials.
|Date:||Wednesday, December 20, 2017|
|Time:||4:00 - 5:00 P.M.|
Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
485 Lexington Avenue
(Between 46th & 47th Streets)
2nd Floor, Conference Room B
New York, New York
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