The Center for Clinical Epidemiology and Biostatistics (CCEB), Leonard Davis Institute (LDI), and Center for Experimental Therapeutics (CET) of the University of Pennsylvania School of Medicine submit this request for the renewal of an innovative and comprehensive clinical research training program, to support and further develop existing training in clinical research. Depending on their career focus, Clinical Research Curriculum Award (CRCA) trainees, who are selected from among those interested in careers as independent investigators in academic clinical research, may enroll in either the Master of Science in Clinical Epidemiology (MSCE) or the new Master of Science in Translational Research (MTR) degree program. The core curriculum for both programs includes courses in research methods, biostatistics, and bioethics. In addition, an introductory longitudinal Patient Oriented Research (POR) course and a series of introductory clinical research methods courses are offered to junior faculty, residents, and fellows, whose research interests still are emerging. Both the MSCE and MTR programs are 2-3 year full time programs consisting of core and elective courses, including shared courses in research methods, biostatistics, and bioethics, along with training in scientific writing and federal human subject research policies and regulations, as well as the development and completion of an independent research project. The longstanding MSCE degree program is designed to produce skilled investigators trained to design and conduct formal clinical research studies of all types. With support from the initial CRCA, this program was substantially expanded and improved and now includes five Tracks: Epidemiology, Health Services Research, Human Genetics, Bioethics, and Clinical Trials. The MTR degree program, developed recently with support provided by the initial CRCA, and which emphasizes mechanism based translational research, is designed to produce skilled investigators who are trained to apply laboratory findings to patients in the conduct of mechanism of human physiology and disease research. The POR and introductory clinical research methods courses, developed and/or expanded with support provided by the initial CRCA, seek to recruit promising junior faculty, residents, and fellows into the fields of patient-oriented research. The semester-long and summer short courses covering introductory clinical research methods and topics, offered for the first time in 2003-04, are designed to introduce faculty, residents, and fellows to clinical research. The nine-month introductory POR course provides an overview of biostatistics, trial design, regulatory affairs, and the mechanics underlying the drug approval process. The strengths of the proposed program are the School of Medicine's exceptional track record of NIH supported clinical research and training; the institutional emphasis on and support for development of expertise in clinical research; the comprehensive course offerings and training options available to trainees; and collaborative links that already have been forged among the CCEB, LDI, and CET; an outstanding, multidisciplinary faculty comprised of highly committed and successful independent clinical investigators and mentors; and the demonstrated success of the initial CRCA. In addition, the proposed program benefits from the availability of the NIH-funded General Clinical Research Center (GCRC), an integrative resource that is used extensively by the CCEB, LDI, and CET. Additional resources include extensive and newly developed laboratories, large databases available for research projects, a range of specialized analytic capabilities, and the commitment, expertise, and unusually complementary track records of the Principal Investigator and co-Principal Investigators in epidemiology, health services research, and mechanism-based research.
| Wong, Yu-Ning; Mitra, Nandita; Hudes, Gary et al. (2006) Survival associated with treatment vs observation of localized prostate cancer in elderly men. JAMA 296:2683-93 |
