Understanding the Statistical Thinking in Clinical Research for Drug Development: Control Overall Fa

Venue: Shanghai Everbright Convention & Exhibition Center

Location: Shanghai, ??, China

Event Date/Time: Oct 23, 2011 End Date/Time: Oct 24, 2011
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Description

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.
FEATURED TOPICS
• 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.
WHO SHOULD ATTEND
• Clinical science
• Regulatory affairs
• Biostatistics and statistical programming
• Data management
• Clinical research operations
• Project management
LEARNING OBJECTIVES
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:
11977

Venue

Room 115 Block A Gateway Plaza
Shanghai
??
China
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