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Activity Number: 226
Type: Topic Contributed
Date/Time: Monday, August 5, 2013 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #307973
Title: Implementing Adaptive Dose-Finding Designs in Oncology Clinical Trials
Author(s): Bo Huang*+ and Paul Bycott and Enayet Talukder
Companies: Pfizer Inc. and Pfizer Inc. and Pfizer Inc.
Keywords: Dose Finding ; Phase I ; Adaptive Design ; Oncology ; MTD

The main objective in phase I oncology trials is to identify a maximum tolerated dose for subsequent studies. Over the past two decades, extensive research has been conducted by statisticians and clinical researchers to create innovative dose finding designs that perform better than the standard 3+3 design, which often exhibits undesirable statistical and operational properties. However, clinical implementation and practical usage have been limited. This article provides some perspectives on implementing adaptive dose finding designs in oncology phase I trials. A case study is provided to illustrate why, how and when novel statistical methodologies are adopted. Operational considerations on how to effectively conduct such trials are discussed.

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

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