application) The proposed training program will be provided to trainees who have completed a year of clinical nephrology training and who will enter the Clinical Research Masters Program at the University of Minnesota. Each trainee will identify a research mentor prior to entering the program. Research will be initiated concurrently with course work in the Masters program. This program includes 38 credit hours of study in epidemiology, biostatistics, clinical trials, literature review and grant writing. It is a new course of study directed by Stephen Glasser who will also sit on the Selection and Steering Committees for the proposed training grant. The research project required for this degree will be combined with an additional year of research with a mentor of the Nephrology training faculty; all projects will be approved by Glasser and the Masters Program Executive Committee. Drs. Rosenberg and Glasser will coordinate communication between the faculty of the Masters and Nephrology Clinical Research programs as is related to these research projects. Trainees will be evaluated on a quarterly basis by the mentor and annually on the basis of scientific presentations and publications by the advisory committee and Steering Committee. In addition to the formal course work and individual research project, trainees will attend conferences in the Renal Division and the Department of Medicine and will participate in a continuity clinic in Nephrology. Administrative structure of the program will include a Steering Committee with representation from the clinical Masters Program, Hennepin County, and the Divisions of Nephrology and Pediatric Nephrology and from the Berman Center for Outcomes and Clinical Research. The Selection Committee will include Division Directors at each of the clinical sites and the Vice Chair of Medicine. Individual Advisory Committees will be provided for each trainee and will be comprised of the advisor and four faculty members. The committee will meet annually and provide review of progress, guidance in use of Core facilities, and advice in seeking continued research funding at the end of the training period. Six research units are described including Transplantation, headed by Dr. Kasiske; ESRD, Dr. Colllins; Progression of Renal Disease, Dr. Hostetter; Diabetic Nephropathy, Dr. Mauer; Hypertension, Dr. Grimm; and Pediatric Nephrology, Dr. Kashtan. Core Resources include: the Clinical Outcomes Research Center (CORC), a joint venture of the Medical School and the School of Public Health, the Berman Center for Outcomes and Clinical Research, Total Renal Research, the NIH funded General Clinical Research Center (GCRC), the Academic Health Center Research Service Organization, Nephrology Analytical Services, and the Coordinating Center for Biometric Research. The CORC provides an epidemiological approach with an emphasis on outcomes of survival and satisfaction, physical and social functioning and quality of life. Support is also provided for prospective studies of therapies with systematic collection of follow-up data. The Berman Center is the research arm of the Division of Clinical Epidemiology at Hennepin County and has been a site for clinical trials since 1965. Total Renal Research is a clinical research facility with emphasis on Phase I through IV trials in patients with hypertension, renal insufficiency, on dialysis, or with renal transplants. The GCRC has a long history of success with NIH funding and includes inpatient and outpatient facilities; over 60 protocols are active. The Research Services Organization provides support to researchers in research protocols, management and performance and interface with industry. Involvement in over 100 proposals has led to initiation of 44 trials in the last two years. Nephrology Analytical Services receives data from HCFA and performs outcomes research regarding ESRD patients. The coordinating Center for Biometric Research is a subunit of the Division of Biostatistics of the School of Public Health. This center will provide access to large databases including several relating to hypertension as well as the USRDS data.
Showing the most recent 10 out of 15 publications
