Clinical Protcol and Data Management

Harold C.西蒙斯癌症中心 临床方案和数据管理 项目总结/摘要 西蒙斯癌症中心的临床方案和数据管理，或临床研究办公室（CRO） 作为临床协调中心的所有活动有关的临床癌症研究在UT 西南部该办事处有55名相当于全职的雇员，由副秘书长Joan Schiller博士监督。 Simmons癌症中心主任和临床研究办公室（CRO）医学总监， 直接监督并负责UTSW和癌症中心的所有临床肿瘤学研究。日至 该办公室的日常管理由临床研究副总监Erin威廉姆斯女士负责 局CRO提供监督、管理和监测肿瘤学的基础设施 临床试验，从而促进整个校园高质量的临床研究。这些活动的集中 确保临床研究的各个方面的标准化，确保患者安全和临床研究的协调。 研究活动。该资源还提供了一个癌症协议的中心位置， 目前正在进行的研究、方案的状态报告以及临床研究的质量控制和培训 人员 临床方案和数据管理核心的目标包括： ·监督。提供中央管理和监督职能， 西蒙斯癌症中心（SCC）的癌症临床试验报告; ·多样性。通过招募不同种族和性别的患者，为SCC的研究使命做出贡献。 治疗性和非治疗性癌症临床试验的种族背景; ·科学知识。通过将基本的，翻译的， 在UT西南医学中心（UTSW）进行的成像研究假设- 驱动临床试验; ·病人护理。通过为我们的癌症提供最先进的临床试验来提供高质量的医疗保健 患者 2009年，在我们最初获得CCSG奖时，有633名患者参加了UTSW的临床癌症试验， SCC。2013年，这一数字上升到1242名参与非人口科学研究的患者，接近2013年的水平。 增加两倍。与人口科学和癌症控制科学计划有关的应计费用 从2009年的726个增加到2013年的37 000多个。此外，正如先前CCSG审查中所建议的，我们 将我们的治疗性研究从2009年的290项增加到2013年的461项。

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.