Speaker：Ken-Ning Hsu Ph.D. Associated Statistics Director and Principle Statistician

  • Event Date: 2022-03-04
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Topic：Statistical Design and Analysis in Phase II Clinical Trials with Applications

Speaker：Ken-Ning Hsu Ph.D. Associated Statistics Director and Principle Statistician

Date Time：FRI. Mar 4, 2022, 10:40 AM - 11:30 AM

Place： 4F-427, Assembly Building I
   

Online Seminars- Google Meet
https://meet.google.com/xcu-vcbo-dsx
Abstract
 
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

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