專題演講 主講人：Ken-Ning Hsu (許根寧) Ph.D. Associated Statistics Director and Principle Statistician (統計副總監與首席統計師) 上海百利佳生醫藥科技有限公司
題 目：Statistical Design and Analysis in Phase II Clinical Trials with Applications
主講人：Ken-Ning Hsu (許根寧) Ph.D. Associated Statistics Director and Principle Statistician (統計副總監與首席統計師) 上海百利佳生醫藥科技有限公司
時 間：111年3月4日(星期五)上午10:40-11:30
(上午10:20-10:40茶會於交大統計所428室舉行)
地 點：綜合一館427室使用Google Meet線上直播，
演講開始前20分鐘可進入會議，請點選下列連結後按下「要求加入」即可
摘要
The objective of a phase II clinical trial is to evaluate the preliminary efficacy of a new treatment and to determine whether an efficacious treatment warrants investigation in a large-scale randomized phase III trial. A fundamental design feature of phase II clinical trial is the early stopping rule to prevent the exposure of an excessive number of patients to a possibly futile treatment. The most well-known is Simon’s optimal two-stage design, which minimizes the expected sample size or the maximum sample size under the null hypothesis that the treatment is not effective, while controlling the type I and type II error. Nevertheless, a Phase II trial could have no hypotheses. In that case, the Bayesian methodology could be used to monitor the efficacy. In the talk, I will introduce a novel design for phase II trials, which has the hypotheses and uses the posterior probability as the test statistic. A real-life phase II clinical trial will be illustrated
