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This book is about Bayesian designs for clinical trials of experimental treatment regimes being given to humans for the first time. A regime’s components may be the dose of a single agent, the dose pair of a two-agent combination, the doses of an agent given in two successive cycles, the schedule of administration, or a (dose, schedule) combination. The regime may comprise the entire therapy given to the patient, or it may be combined with other agents that are given at fixed doses and schedules, or possibly with a procedure such as surgery. The scientific goals of these trials are to explore, refine, and, ideally, optimize the regime. All of the designs that we will discuss include sequentially adaptive treatment decisions for small, successive cohorts of patients, based on very small amounts of regime-outcome data from previous patients.
The need to make decisions sequentially in this way is motivated by the ethical concern that some of the treatment regimes being studied may be unsafe due to excessive Toxicity. Consideration of Efficacy along with Toxicity motivates the additional concern that some regimes may be ineffective in terms of anti-disease effect. If this were not the case, then one could proceed much more simply by randomizing patients among the regimes, possibly imposing a restriction to balance the sample sizes of the regimes.
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