Clinical Trials

Directed by Pankaj Desai, PhD

The overall objective of the Clinical Trials Focus Area is to train clinical researchers interested in clinical trials and translational research. Trainees concentrating in Clinical Trials will learn the fundamentals of clinical trials and the drug/device development process, including the responsible conduct of research, the phases of clinical trials, and regulatory affairs. A unique aspect of the curriculum is that UC professors team with industry leaders to teach several of the courses, so that students get a “real world” experience. The electives for this Focus Area are taught through the College of Pharmacy.

These trainees gain the skills required to effectively complete investigator-initiated, IND-directed early phase clinical trials. Trainees learn critical aspects of study design and conduct, mechanisms of financial support, and data analysis and publication. A basic understanding of laboratory methods, data analysis, and the molecular basis of disease is critical to bridge laboratory and clinical research and is therefore included in the training. The curriculum covers training in pre-clinical efficacy and toxicology studies that are required to support early phase clinical trials. In addition, regulatory affairs issues unique to translational research are covered.

Course Number

Course Title

Credit Hours

Quarter

BE-7066 Principles of Clinical Trials 3 F
PHDD-8010 Global Regulatory & Development Strategies of Drugs & Medical Devices 3 F
PHDD-8050 Phase I/II Clinical Trials Research and Design 3 F
PHDD-8070 Phase III/IV Clinical Trials & Research 3 S
PHDD-8040 Developmental & Manufacturing of Drug Products & Medical Devices 3 S