CTA 5200 - Clinical Trial Design and Statistical Concepts

The course is designed to allow the student to develop an understanding of the use and importance of statistics in drug development. This course will teach the fundamental statistical concepts used in the design, analysis and regulatory review of clinical studies and drug dossiers. It will provide an understanding of the basic statistical theory used in the interpretation of clinical trial efficacy and safety results. It will give the student an understanding of the statistical requirements applied by regulatory agencies in their review processes.

Credits: 3 hrs.