PMC 6212. Clinical Drug Development Data Analysis: Concepts. (4 Hours)

Examines the process of planning, collecting, analyzing, and reporting data from drug development studies. Focuses 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. Covers 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.

Prerequisite(s): PJM 6000 with a minimum grade of C- or (BTC 6210 with a minimum grade of C- ; RGA 6000 with a minimum grade of C- ; RGA 6001 with a minimum grade of C- )

PMC 6962. Elective. (1-4 Hours)

Offers elective credit for courses taken at other academic institutions. May be repeated without limit.