This competing application seeks to renew the didactic Clinical Research Methodology Curriculum (CRMC) at Memorial Sloan-Kettering Cancer Center (MSKCC). Faculty from the Departments of Anesthesiology and Critical Care, Epidemiology and Biostatistics, Medicine, Surgery, Radiation Oncology, Pediatrics, Neurology, Urology, Psychiatry and Behavioral Sciences will participate in a two-year, multidisciplinary program that provides the didactic course work and fundamental skills required for a successful career as an independent clinical researcher. The proposed curriculum represents a substantial enhancement and programmatic evolution from the initial application. Four didactic research methodology modules provide comprehensive and in-depth instruction in the methodology and theory fundamental to sound clinical research. They include: 1) Investigational drug and medical device development from pre-clinical testing to FDA approval; 2) Clinical research in outcomes analysis, psychometric measurements, biological markers, and epidemiology; 3) Ethical conduct, regulations involving human subject research, data management, reporting responsibilities, institutional oversight, and conflict of interest in clinical investigations; 4) Clinical trial designs, integration of correlative sciences, ethical considerations, and regulatory oversight. The curriculum also includes a course in biostatistics and highly interactive workshops in both grant writing and clinical protocol development that provide additional training in hypothesis testing and clinical trial methodology. Since its inception, the program has been successful in achieving its goal of training independent clinical researchers in diverse disciplines including Obstetrics and Gynecology, Orthopedic Surgery, Otolaryngology, General Surgery, Urology, Oncology, Pediatric Oncology, Neurology, Psychiatry and Behavioral Sciences, and Radiation Oncology. These investigators have outstanding records of academic matriculation and extramural funding for their clinical research and have published over 300 manuscripts. The independent clinical investigators trained by this curriculum are already emerging leaders in biomedical research, providing intellectual leadership as Principal or Co-Principal Investigators for 75 IRB-approved research protocols nationwide. This competitive renewal demonstrates our substantial commitment to the training of clinical investigators and the success of the CRMC in achieving that goal.
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