Project Summary The Department of Biostatistics, Epidemiology, and Informatics (DBEI), the Center for Clinical Epidemiology and Biostatistics (CCEB) and the Center for Pharmacoepidemiology Research and Training (CPeRT) of the University of Pennsylvania (Penn) Perelman School of Medicine submit this renewal application to continue and improve our innovative and highly successful post-doctoral training program in clinical pharmaco- epidemiology. Pharmacoepidemiology is the study of the use and effects of medications and other medical products in populations. Our training program attracts highly qualified clinicians from across the nation. This two- to three-year intensive clinical research training program is designed to: 1) train clinicians to be rigorous and independent investigators able to formulate research questions and use a wide range of pharmacoepidemiologic approaches to answer those questions; 2) provide an understanding of the basic principles of clinical pharmacology; 3) provide intensive, supervised research experience with mentors in clinical pharmacoepidemiology and other content-area mentors; and 4) strengthen the links between clinical epidemiology and clinical pharmacology. To learn the basic sciences of clinical research, fellows matriculate in our highly-successful Master of Science in Clinical Epidemiology (MSCE) or PhD in Epidemiology degree programs and complete required courses in clinical epidemiology, pharmacoepidemiology, outcomes measurement, biostatistics, and database management; elective courses in drug development, pharmacology and other areas relevant to the fellows' interests and experience; independent readings; and participation in research seminars and other activities within DBEI/CCEB and CPeRT. These skills are applied to the primary focus of the training program, which is the design, implementation, analysis, and publication of mentored independent research projects of the fellow's design that targets their independent research career goals. Strengths of the program include: 1) the large pool of highly qualified candidates with clinical training seeking rigorous research training in pharmacoepidemiology; 2) the long history of successful research training programs in the DBEI/CCEB, including in pharmacoepidemiology and comparative effectiveness research/patient-centered outcomes research; 3) the comprehensive course offerings and research programs available to fellows; and 4) the successful training record of the program director and other faculty. In addition, the availability of the CPeRT and other CCEB faculty, who provide expertise in a wide range of methodologic and clinical disciplines; numerous epidemiologic databases useful for research projects and training; a broad array of specialized analytic capabilities available for clinical studies (e.g., clinical trials, case-control, cohort, self-controlled designs); and the faculty members' commitment to collaborative research and training, combine to provide an ideal environment for this program.

Project Narrative There is a major national shortage of qualified clinicians trained to conduct rigorous research in clinical pharmacoepidemiology, and in particular research focusing on drug safety and comparative effectiveness research/patient-centered outcomes research. This training program helps to address this shortage by providing clinicians with rigorous didactic training and the opportunity to conduct mentored research mentored by outstanding program faculty.