Clinical Protcol and Data Management

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Harold C. Simmons Cancer Center Clinical Protocol and Data Management Project Summary/Abstract The Simmons Cancer Center's Clinical Protocol and Data Management, or Clinical Research Office (CRO) serves as the clinical coordinating center for all activities related to clinical cancer research at UT Southwestern. The office has 55 full-time-equivalent employees and is overseen by Dr. Joan Schiller, Deputy Director of the Simmons Cancer Center and Medical Director of the Clinical Research Office (CRO) who has direct oversight and responsibility for all clinical oncology research at UTSW and the Cancer Center. Day-to- day management of this office is headed by Ms. Erin Williams, Associate Director of Clinical Research Administration. The CRO provides infrastructure for oversight, management, and monitoring of oncology clinical trials, thus facilitating high-quality clinical research across our campus. Centralization of these activities ensures standardization of all aspects of clinical research, ensuring patient safety and coordination of clinical research activities. The resource also provides a central location for cancer protocols, an updated list of currently active studies, status reports of protocols, and quality control and training for clinical research personnel The goals of Clinical Protocol and Data Management Core include: · Oversight. Provide central management and oversight functions for the coordination, facilitation, and reporting of cancer clinical trials at the Simmons Cancer Center (SCC); · Diversity. Contribute to the research mission of the SCC by enrolling patients with diverse ethnic and racial backgrounds to therapeutic and non-therapeutic cancer clinical trials; · Scientific knowledge. Contribute to the scientific direction of the SCC by bringing the basic, translational, and imaging research conducted at UT Southwestern Medical Center (UTSW) into hypothesis- driven clinical trials; · Patient care. Provide high-quality health care by offering state-of-the-art clinical trials to our cancer patients. In 2009, at the time of our initial CCSG award, 633 patients were accrued to clinical cancer trials at UTSW and the SCC. In 2013, that figure had risen to 1242 patients enrolled on non-population science studies—close to a twofold increase. Accrual associated with the Population Science and Cancer Control Scientific Program increased from 726 in 2009 to over 37,000 in 2013. In addition, as suggested in the prior CCSG review, we increased our accrual to therapeutic studies from 290 in 2009 to 461 in 2013.