交通大学、清华大学 统计学研究所 专题演讲 题　目：Inference on Treatment Effects for Targeted Clinical Trials under Enrichment Design 主讲人：林志荣教授 (长庚大学 临床资讯与医学统计研究中心) 时　间：99年5月7日(星期五)上午10:40-11:30 (上午10:20-10:40茶会於交大统计所429室举行) 地　点：交大综合一馆427室 Abstract After completion of a human genome project, the disease targets at molecular level can be identified. As a result, treatment modality for molecular targets can be developed. In practice, targeted clinical trials are usually conducted for evaluation of the possibility and feasibility of the individualized treatment of patients. However, the accuracy of diagnostic devices for identification of such molecular targets is usually not perfect. Therefore, some of the patients enrolled in targeted clinical trials with a positive result by the diagnostic device might not have the specific molecular targets and hence the treatment effects of the targeted drugs estimated from targeted clinical trials could be biased for the patient population truly with the molecular targets. Under an enrichment design for targeted clinical trials, we propose to use the EM algorithm and bootstrap method for obtaining the inference of the treatment effects of the targeted drugs in the patient population truly with molecular targets. A simulation study was conducted to empirically investigate the bias and variability of the proposed estimator and the size and power of the proposed testing method. A practical example illustrates the utility of the proposed method. -- --

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