Early-Phase Clinical Trials

• Activity Number: 482
• Type: Topic Contributed
• Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Committee on ASA Archives and Historical Materials
• Author(s): Nancy Flournoy* and Assaf Oron
• Companies: University of Missouri - Columbia and Seattle Children's Research Institute
• Keywords: dose-response ; nonlinear function estimation ; adaptive design ; optimal design ; experimental design ; up-and-down designs

Abstract

We review developments in early phase clinical trial design. We will discuss and compare the "standard" 3+3 design, uniform designs, and classical stochastic approximation with more novel procedures including up-and-down designs, interval designs, adaptive optimal designs, the continual reassessment method and other Bayesian approaches. We focus on the distinguishing concepts and goals behind the various approaches.