【学术讲座】Design and Analysis of Drug Combination Studies and Biomarker Evaluation in Drug Development

发布者:系统管理员发布时间:2015-03-17浏览次数:33

学术报告

报告题目:Design and Analysis ofDrug Combination Studies, Clinical Trials and Biomarker Evaluation in DrugDevelopment

人:Dr. Ming T. Tan, Professor & Chair

Dept of Biostatistics, Bioinformaticsand

Biomathematics,GeorgetownUniversity

间:2015320(星期五)上午10:30

点:数学楼第三报告厅

要:Combinationtherapy is the hallmark of therapies for cancer, viral or microbial infections,hypertension and other diseases involving complex biological networks.Synergistic drug combinations, which are more effective than predicted fromsumming effects of individual drugs, often achieve increased therapeutic index.Because drug-effect is dose-dependent, multiple doses of an individual drugneed to be examined, yielding rapidly increasing number of combinations and achallenging high dimensional statistical modeling problem. The lack of properdesign and analysis methods for multi-drug combination studies have resulted inmany missed therapeutic opportunities. In this talk, I will present anefficient experimental design on selected multi-drug combinations, statisticalmodeling of the resulting data and the proof of its statistical properties.Then I will present an adaptive Bayesian phase I trial design for multidrugcombinations using the modeling concept and an adaptive design for phase IIIclinical trials and their analysis in the context of identifying predictivebiomarkers.

报告人简介:

谭铭(Ming T. Tan)教授,乔治敦大学生物统计系主任。谭教授于1986年赴美国留学,1990年获得普渡大学博士学位,1996年起即在美国受聘正教授,2012年从马里兰大学癌症研究所的生物统计中心主任离职,受聘乔治敦大学。谭铭教授在国际生物统计界享有盛誉,是国际上三大著名生物统计期刊BiometricsStatisticsin MedicineDrugDesign, Development and TherapyAE。谭教授在美国卫生研究院(NIH)、科学审查委员会、数据与安全监测委员会和FDA咨询委员会等多个机构任职。他是美国统计协会Fellow,国际统计学会Elected Member。发表论文共计169篇,出版专著(章节)7本。

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统计研究院

2015316