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675 – Advances in Time Series Analysis
Implementing Adaptive Dose-finding Designs in Oncology Clinical Trials
Bo Huang
Pfizer Inc.
Paul Bycott
Pfizer Inc.
Enayet Talukder
Pfizer Inc.
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.