Clinical Drug Development Data Analysis: Concepts and Applications

Starting with the fall 2009 term, this course will be renumbered as PMC 6212.

In this course, students will examine the process of planning, collecting, analyzing, and reporting data from drug development studies. The focus is on the goals of each phase (1-4) of the clinical drug development process and how to achieve these objectives within the confines of the FDA regulations and ICH guidelines. In addition, students will consider requirements in other countries, including the UK Data Protection Act, issues related to the differences between the development of drugs for oncologic or AIDS indications compared to traditional drugs, cultural influences, current standards of therapy, the need for validated tools, and failure analyses.

There are no current sections scheduled for this course number.
Please note that courses have been assigned new numbers beginning with the fall term.
Please check the new course number for course availability.