Event: DIA China Statistical Workshop

Dates: October 23 - 24, 2011

Venue: Everbright Int'l Hotel, Shanghai, China

Weblink: www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=27529&eventType=Meeting

Contact: Mr. Fei Xie

Tel: +86 10 5923 1222, 5923 1288
Email: dia@diachina.org

 

Built upon the success of DIA China statistical workshop in the past two years, this two-day workshop is another in-depth, practical, and basic-to-intermediate level tutorial in the design and statistical methodologies in clinical trials. In clinical trials, we often face the concepts and issues of multiple comparisons, multiple endpoints, interim analysis, and sample size re-estimate. Why are they so common in clinical trials, what do they refer to, how to handle these issues, and what is their relationship to the issue of false positive finding of clinical trials outcomes, which is the one of the regulatory focuses in the clinical evaluation of new drug application? This course will focus on these concepts and issues. Real life clinical trial examples will be used to illustrate these concepts and underlying statistical methodologies.

 

 

At the end of the workshop, participants should be able to

 

- Understand the issue of the false positive finding of clinical trials and its scientific and regulatory
  implication;

 

- Recognize some common designs and analyses related to the issue of false positive finding;

 

- Understand the concept and statistical methodology in the design and implementation of group
  sequential design and analysis (interim analysis); and

 

- Understand the common statistical approaches to multiple comparisons and multiple endpoints in
  the context of controlling overall false positive error rate.