The course covers seven important topics that commonly face statisticians and research scientists conducting clinical research: stratified trials, longitudinal trials with dropouts, time-to-event trials with small sample sizes, crossover trials, pharmacogenomics studies for personalized medicine, multiple comparisons, and interim decision making with 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 as well as contract research organizations. It is equally beneficial to statisticians working in institutions that deliver health care, government branches that conduct health-care related research and academics interested in learning about contemporary statistical topics in clinical drug development. The attendees are required to have a basic knowledge of clinical trials. Familiarity with drug development is highly desirable, but not necessary.
This course was taught at JSM 2005-2017 and received the Excellence in Continuing Education Award in 2005.