Multiple-dosing per cohort in phase I and phase I/II clinical trials

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University of Wisconsin--Madison, 2008 - Architecture - 131 pages
A new class of dose-finding designs in phase I/II clinical trials in cancer combining both toxicity and efficacy are delineated in the second major part. Instead of trying to find a single optimal dose, I would like to identify an acceptable region in which doses are both effective and safe, along with the optimal one within the region. For each cohort of three patients, the currently estimated minimum effective dose (MED), most successful and acceptable dose (MSAD) which maximizes the probability of joint efficacy and no toxicity, and maximum tolerated dose (MTD) are each assigned to a patient. Simulation results show that the new designs exhibit good operating characteristics and have competitive performance compared with the existing designs. Confidence sets for the MED and MTD are also established to gain further assurance and to have a flexible manipulation of the acceptable region.

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ThreeDoseCohort Designs in Phase I Trials
The DoseFilter Designs Modeling both Toxicity and Efficacy

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