临床试验生物统计方法
2017年3月20日，21日，23日，24日，27日
下午1:00pm—4:30pm
闵行校区统计楼105
Dr Richard Chappell
Depts. of Statistics and of Biostatistics & Medical Informatics
University of Wisconsin-Madison
课程内容：
1. Introduction to types of medical studies and their biases (nonmathematical)
a) Types of medical studies
i) instantaneous (surveys)
ii) retrospective
iii) prospective
b) Biases in medical studies
i) detection
ii) selection
iii) publication
c) a case study: The US Women's Health Initiative
2. Randomization
i) introduction
ii) balancing methods - balance vs. entropy
iii) covariate-adaptive methods
iv) response-adaptive methods; dangers and solutions
3. Phase I trials
i) phase I feasibility trials, with an example from neurology
ii) introduction to phase I dose-escalation trials, with examples from cancer
iii) advanced topics in phase I dose-escalation trials
a) advanced algorithmic designs
b) advanced Bayesian designs
c) combining algorithmic and Bayesian designs
4. Phase II trials
i) introduction to phase II trials
ii) single-stage trials (Gehan)
iii) two-stage phase trials (Simon)
iv) advanced topics in phase II trials
5. Biomarker-based trials
i) introduction
ii) enrichment trials
iii) parallel primary hypotheses
iv) a case study: BATTLE
6. Non-inferiority trials
i) introduction
ii) a case study from neurology (SPORTIF)
iii) choice of scale for the null hypothesis
a) changing the scale for purposes of power/interpretation (with X Wei)
b) using the additive scales in survival analysis (with L McDaniel)
3月22日下午1:00pm—3:00pm
The Design and Analysis of Non-Inferiority Trials at DIA Q1 event
南京西路1601号越洋国际广场29楼 勃林格殷格翰
报告人简介：
Rick Chappell
Professor, Departments of Statistics and of Biostatistics and Medical Informatics, University of Wisconsin Madison
Professor Chappell has been faculty at the University of Wisconsin for 26 years. His methodological research is in the areas of designs for clinical trials including Phase I clinical trials and non-inferiority trials as well as longitudinal and generalized linear models and survival analysis. He collaborates extensively with investigators in the University of Wisconsin School of Medicine and Public Health, nationally, and internationally, with specializations in mental health, aging, radiation biology in cancer, and randomized clinical trials. He has been on several US FDA advisory committees, been a member of approximately 25 DSMBs for the NIH, VA, and industry, been made Fellow in the American Statistical Association and the Society for Clinical Trials, and elected president of the latter. For ten years he taught trial methodology to young clinical researchers for the American Society for Clinical Oncology and the American Association for Cancer Research.