ABSTRACT

This chapter provides an overview of Bayesian concepts and methods for design and conduct of clinical trials of treatment regimens, including targeted agents. A targeted treatment regimen may consist of one agent, a combination of agents, or a sequence of agents given over multiple stages, and it also may specify the dose, schedule, or schedule-dose combinations of each agent. The illustrations include Bayesian dose-ˆnding based on time to toxicity, dose-ˆnding based on both toxicity and efˆcacy, and randomized trials to evaluate effects of multiple targeted regimens on efˆcacy or an event time such as progression-free survival (PFS) or overall survival (OS) time.