[生物书合集].Advances.in.Clinical.TBiostatisti

[生物书合集].Advances.in.Clinical.TBiostatisti

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1 Bayesian Methods for Cancer Phase I Clinical Trials James S. Babb and Andre ´ Rogatko Fox Chase Cancer Center, Philadelphia, Pennsylvania, U.S.A. 1. INTRODUCTION 1.1. Goal and Definitions The primary statistical objective of a cancer phase I clinical trial is to determine the optimal dose of a new treatment for subsequent clinical evaluation of efficacy. The dose sought is typically referred to as the maximum tolerated dose (MTD), and its definition depends on the severity and manageability of treatment side effects as well as on clinical attributes of the target patient population. For most anticancer regimens, evidence of treatment benefit, usually expressed as a reduction in tumor size or an increase in survival, requires months (if not years) of obser- vation and is therefore unlikely to occur during the relatively short time
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Unformatted text preview: course of a phase I trial (O’Quigley et al., 1990; Whitehead, 1997). Consequently, the phase I target dose is usually defined in terms of the prevalence of treatment side effects without direct regard for treatment efficacy. For the majority of cytotoxic agents, toxicity is considered a prerequisite for optimal antitumor activity (Wooley and Schein, 1979) and the probability of treatment benefit is assumed to monotonically increase with dose, at least over the range of doses under consideration in the phase I trial. Consequently, the MTD of a cytotoxic agent typically corresponds to the highest dose associated with a tolerable level of Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved....
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This note was uploaded on 06/13/2011 for the course PHYSICS 101 taught by Professor Shu during the Spring '11 term at FIU.

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