Understanding the Statistical Thinking in Clinical Research for Drug Development: Control Overall False Positive Rate in Clinical Trials to Ensure the Validity of Trial Results

Date(s) And Time(s):
Oct 23 2011 8:00AM - Oct 24 2011 5:00PM

Shanghai Everbright Convention & Exhibition Center Internati
66 Cao Bao Road
Xuhui District
200000 Shanghai

Learn Statistical Methodologies for Better Design and Control of Clinical Trials
This two-day workshop will provide in-depth, practical, and basic-to-intermediate level tutorial in the design and statistical methodologies in clinical trials. The workshop features opportunities for statistical learning and increasing your clinical trial success.
• Multiple comparisons and endpoints
• Interim analysis
• Sample size re-estimation
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 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.

• Clinical science
• Regulatory affairs
• Biostatistics and statistical programming
• Data management
• Clinical research operations
• Project management
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)
• Understand the common statistical approaches to multiple comparisons and multiple endpoints in the context of controlling overall false positive error rate

Event Code:
Tel: +86-10-59231109 Fax: +86-10-59231090, www.diahome.org, dia@diachina.org