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

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

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Unformatted text preview: Bayesian Methods for Cancer Phase I Clinical Trials 5 Table 1 Dose Level of 5-FU (mg/m2) and Binary Assessment of Treatment-Induced Toxic Response for the 12 Patients in the 5-FU Phase I Trial Patienta 1 2 3 4 5 6 7 8 9 10 11 12 a 5-FU Dose Response 140 210 250 273 291 306 318 328 337 345 352 338 No DLT No DLT No DLT No DLT No DLT No DLT No DLT No DLT No DLT No DLT DLT DLT Patients are listed in chronological order according to date of accrual. PNU Trial The incorporation of patient-specific covariate information into a Bayesian design scheme will be exemplified through a phase I study of PNU214565 (PNU) involving patients with advanced adenocarcinomas of gastrointestinal origin (Babb and Rogatko, 2001). Previous clinical and preclinical studies demonstrated that the action of PNU is moderated by the neutralizing capacity of anti-SEA antibodies. Based on this, the MTD of PNU was defined as a function of the pretreatment concentration of circulating anti-SEA antibodies. Specifically, the MTD was defined as the dose level expected to induce DLT in a proportion u = .1 of the patients with a given pretreatment anti-SEA concentration. 2. GENERAL BAYESIAN METHODOLOGY The design and conduct of phase I clinical trials would benefit from statistical methods that can incorporate information from preclinical studies and sources outside the trial. Furthermore, both the investigator 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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