Using a combination of didactic material and seminars, the Clinical Epidemiology/Clinical Effectiveness Focus Area enables participants to develop the analytic and quantitative skills necessary to conduct clinical research. The required courses will provide training in traditional epidemiologic research methods including study design and analysis. Additional courses will address the relative merits of various designs; the design and conduct of clinical trials; the health decision sciences; health services research; informatics; questionnaire development; and other clinical and outcomes research topics. Didactic sessions will be supplemented by small discussion groups, practical exercises, and invited guest speakers.
 

Directed by Grace LeMasters, PhD

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. 
 

 
Translational Research

Directed by Timothy Cripe, PhD, MD

Translational research is broadly defined as research that will provide a scientific link between laboratory research and human clinical practice. This area includes preclinical and early phase clinical testing of new therapeutic or diagnostic reagents, as well as collection and handling of patient specimens. Students will take courses in the College of Pharmacy geared towards clinical trials and regulatory affairs and in Developmental Biology, Disease and Development. Two new courses have been created for this focus area: Patient Specimen Methods and Disease Specific Translational Research. To gain a more solid understanding of the molecular mechanisms underlying diseases, trainees may fill the elective hours with the molecular biology series offered at UC each year. Ideally, research projects will encompass late preclinical or early clinical projects.