交通大學、清華大學 統計學研究所 專題演講 題　目：Inference on Treatment Effects for Targeted Clinical Trials under Enrichment Design 主講人：林志榮教授 (長庚大學 臨床資訊與醫學統計研究中心) 時　間：99年5月7日(星期五)上午10:40-11:30 (上午10:20-10:40茶會於交大統計所429室舉行) 地　點：交大綜合一館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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