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Abstract:
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This one-day short course will cover a variety of Bayesian sequentially adaptive phase I-II clinical trial designs that use both efficacy and toxicity to optimize dose, the dose pair of a two-agent combination, two doses given in sequence, or dose and schedule. The course will begin with an explanation of fundamental flaws with the conventional paradigm that separates phase I and phase II, followed by an overview of phase I-II designs. The remainder of the course will cover specific designs, with each illustrated by a practical application, including basic design structure, establishing numerical values of design parameters and prior parameters, and computer simulations to establish operating characteristics. Examples will include designs based on efficacy-toxicity probability trade-offs or elicited joint utilities of efficacy and toxicity, designs with binary, categorical, or time-to-event outcomes, methods for dealing with late onset outcomes, personalized (precision) dose-finding, optimizing molecularly targeted agents, two-agent combination trials, and methods for dealing with drop-outs.
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