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• W813245842 abstract "The clinical trial is the most import study for the development of successful novel drugs. The aim of this dissertation is to develop innovative statistical methods to overcome the three main obstacles in clinical trials: (1) lengthy trial duration and inaccurate maximum tolerated dose (MTD) in phase I trials; (2) heterogeneity in drug effect when patients are given the same prescription and same dose; and (3) high failure rates of expensive phase III confirmatory trials due to the discrepancy in the endpoints adopted in phase II and III trials. Towards overcoming the first obstacle, we originally develop a hybrid design for the time-to-event dose escalation method with overdose control using a normalized equivalent toxicity score (NETS) system. This hybrid design can substantially reduce sample size, shorten study length, and estimate accurate MTD by employing a parametric model and adaptive Bayesian approach. Toward overcoming the second obstacle, we propose a new approach to incorporate patients’ characteristic using our proposed design in phase I clinical trials which considers the personalized information for patients who participant in the trials. To conquer the third obstacle, we propose a novel twostage screening design for phase II trials whereby the endpoint of percent change in of tumor size is used in an initial screening to select potentially effective agents within a short time interval followed by a second screening stage where progression free survival is estimated to confirm the efficacy of agents. These research projects will substantially benefit both cancer patients and researchers by improving clinical trial efficiency and reducing cost and trial duration. Moreover, they are of great practical meaning since cancer medicine development is of paramount importance to human health care. INDEX WORDS: Clinical trial design, Phase I, Phase II, Maximum tolerated dose (MTD), Adaptive design, Personalized MTD, Covariate effect, Two-stage design, Success rate, Trial efficiency ADVANCED DESIGNS OF CANCER PHASE I AND PHASE II CLINICAL TRIALS" @default.
• W813245842 created "2016-06-24" @default.
• W813245842 creator A5042177993 @default.
• W813245842 date "2013-01-01" @default.
• W813245842 modified "2023-09-23" @default.
• W813245842 title "Advanced Designs of Cancer Phase I and Phase II Clinical Trials" @default.
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