JSM 2015 Online Program

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Legend: Washington State Convention Center = CC, Sheraton Seattle = S, Grand Hyatt = GH and The Conference Center = TCC
* = applied session       ! = JSM meeting theme

Activity Details

CE_12C Mon, 8/10/2015, 8:00 AM - 12:00 PM S-Grand Ballroom A
Concepts and Implementation of Bayesian Adaptive Phase I Oncology Trials (ADDED FEE) — Professional Development Continuing Education Course
ASA , Biopharmaceutical Section
Phase I trials in oncology are usually small adaptive dose-escalation trials. The aim is to approximately understand the dose-toxicity profile of a drug, and, eventually, to find a reasonably safe dose for future testing. Much statistical research for phase I trials has accumulated over the past 25 years, with modest impact on statistical practice. The vast majority of trials still follow the 3+3 design, despite it often missing the targeted dose (poor operating characteristics) and failing to provide a real understanding of true toxicity rates (no statistical inference). We present a comprehensive and principled statistical approach. The implementation is Bayesian, with the following main parts: a parsimonious model for the dose-toxicity relationship, the possibility to incorporate contextual information ("historical data") via priors, and safety-centric metrics (overdose probabilities) that inform dose adaptations under appropriate overdose control. After basic clinical and statistical considerations, we introduce the statistical methodology for the single-agent setting, and then extend it to dual and triple combinations. Applications and a discussion about implementation (such as basic WinBUGS code) issues complement this training and provide practical insights into phase I trials.
Instructor(s): Satrajit Roychoudhury, Novartis Pharmaceuticals, Beat Neuenschwander, Novartis Pharma AG

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