Clinical research is critical for the advancement of scientific knowledge and the development of cures and improved treatment for disease. Tremendous advances in biology provide insights into human physiology, pathophysiology and disease, and pharmacology and therapeutics -- creating extraordinary opportunities for clinical research. Correspondingly, clinical observations frequently can provide the starting point and impetus for new insights into human biology, which can be made with the aid of new biological techniques. Yet, studies at the Institutes of Medicine, the National Research Council, the National Academy of Sciences, and the National Institutes of Health (through two committees - one examining funding of clinical research [the Division of Research Grants Ad Hoc Clinical Research Study Group] and the second evaluating the overall role of the National Institutes of Health in fostering clinical research [the NIH Directors Advisory Committee on Clinical Research]) have clearly documented large deficiencies in our capacity for clinical research. While the Institute of Medicine's report identified several obstacles impeding researchers interested in clinical research, deficits in the training of the clinical scientist were highlighted. Most programs are unplanned, fragmented, frequently undervalued, and without appropriate infrastructure, accountability or continuity. The Institute of Medicine committee recommended that """"""""Post-graduate training programs implement programmatic changes to ensure that residencies and fellowship training programs include on-going exposure to basic elements of [patient-oriented research]"""""""". This proposal - Scholars in Clinical Science Program (SCSP) - addresses this recommendation. Its goal is to provide a superior, coordinated didactic and practical training program in translational investigation (human physiology, pathophysiology and genetics), human pharmacology and clinical trials for 20-40 individuals. It brings together the expertise and resources, including five General Clinical Research Centers, from all three of Harvard University's medically-oriented schools: the Medical School (HMS), the School of Dental Medicine (HSDM), and the school of Public Health (HSPH); five of its major teaching hospitals: Beth Israel/Deaconess Medical Center (BIDMC), the Brigham and Women's Hospital (BWH), the Dana Farber Cancer Institute (DFCI), the Children's Hospital Medical Center (CHMC), the Massachusetts General Hospital (MGH); and resources at the Harvard Business School and the Massachusetts Institute of Technology.
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