Clinical Protcol and Data Management

哈罗德·西蒙斯癌症中心 临床方案和数据管理 项目摘要/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) 作为德克萨斯大学所有与临床癌症研究相关的临床协调中心 西南部。该办公室有55名相当于全职的员工，由副主任琼·席勒博士负责监督 西蒙斯癌症中心主任兼临床研究办公室(CRO)医学主任 直接监督和负责UTSW和癌症中心的所有临床肿瘤学研究。日常工作- 该办公室的日常管理由临床研究副主任Erin Williams女士领导 行政部门。CRO为肿瘤学的监督、管理和监测提供基础设施 临床试验，从而促进了我们校园内的高质量临床研究。这些活动的集中化 确保临床研究的方方面面标准化，确保患者安全和临床协调 研究活动。该资源还提供了癌症方案的中心位置、最新的 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 人事 临床方案和数据管理核心的目标包括： ·监督。提供集中管理和监督职能，以协调、促进和 报道西蒙斯癌症中心(SCC)的癌症临床试验； ·多样性。通过招募不同种族和不同种族的患者，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。为SCC的科学方向做出贡献，将基础、翻译、 和在德克萨斯大学西南医学中心(UTSW)进行的成像研究进入假说- 推动临床试验； ·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 病人。 2009年，当我们首次获得CCSG奖时，UTSW和UTSW有633名患者参加了临床癌症试验 SCC。2013年，这一数字上升到参加非人口科学研究的1242名患者-接近 两倍的增长。与人口科学和癌症控制科学计划相关的应计项目 从2009年的726人增加到2013年的37,000多人。此外，正如先前CCSG审查中所建议的那样，我们 我们对治疗性研究的应计费用从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.