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Activity Number: 422
Type: Topic Contributed
Date/Time: Tuesday, August 2, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #319954 View Presentation
Title: Practical Experiences with Adaptive Dose-Escalation Designs in Early-Phase Oncology Trials
Author(s): Inna Perevozskaya*
Companies: Pfizer
Keywords: Phase I trials ; dose-escalation ; oncology ; adaptive design ; continual re-assessment method ; modified toxicity probability interval
Abstract:

The methodology development for first innovative dose-escalation designs dates back to a couple of decades ago. Today many methods are available for statisticians to use and their statistical efficiency over traditional 3+3 design is well documented by numerous publications. Despite these methodological advances, the general level of acceptance of innovative adaptive designs in Phase 1 oncology remains low. The barrier is often not the methodology but rather cautious attitudes towards novel designs and implementation challenges. In this presentation we will review two case studies utilizing adaptive design in a phase 1 oncology trial: one implementing Continual Re-assessment Method (CRM) and the other one using modified toxicity probability interval method. A review of study design will be given but the focus will be on practical aspects of implementation and associated challenges.


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

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