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Abstract:
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This course covers six important topics that commonly face statisticians and research scientists conducting clinical research: analysis of stratified trials, analysis of longitudinal data with dropouts, analysis of time-to-event data (with emphasis on small trials), crossover trials, multiple comparisons, and interim decision making and adaptive designs. The course offers a well-balanced mix of theory and applications. It presents practical advice from experts and discusses regulatory considerations. The discussed statistical methods will be implemented using SAS and R software. Clinical trial examples will be used to illustrate the statistical methods. The course is designed for statisticians working in the pharmaceutical or biotechnology industries and contract research organizations. It is equally beneficial to statisticians working in institutions that deliver health care and government branches that conduct health care-related research. Attendees are required to have basic knowledge of clinical trials. Familiarity with drug development is highly desirable, but not necessary. This course was taught at JSM 2005-2015 and received the Excellence in Continuing Education Award in 2005.
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