Clinical Protocol and Data Management

西蒙斯综合癌症中心（SCCC）临床方案和数据管理（CPDM） 章节报告了与（1）临床研究办公室（CRO），（2）数据和安全性监查相关的信息 委员会，（3）将妇女和少数民族纳入临床研究，以及（4）将个人纳入临床研究 临床研究中的生命周期。这些努力，沿着方案审查和监测， 系统（PRMS）由SCCC临床癌症研究委员会密切监测，该委员会由 大卫E. Gerber，MD（临床研究副总监）。首席风险官在M. Shaalan Beg，MD（CRO医学总监）和Erin威廉姆斯，MBA（CRO行政总监），提供 为所有肿瘤临床治疗的实施和管理提供全面、集中的服务 在UT西南医学中心（UTSW）及其附属医疗机构进行的研究 系统，帕克兰健康和医院系统和儿童医疗中心。CRO作为 所有癌症研究的中央存储库，保持研究活动的实时报告，并提供 为所有临床研究人员提供培训和标准操作规程（SOP）库。数据 和安全监测委员会（DSMC），由乔纳森·道尔，医学博士，独立运作的 PRMS和CRO，并对所有患者的不良事件和方案依从性进行基于风险的监测 SCCC干预性试验。DSMC由一个三人质量保证小组提供支持， 根据SCCC国家癌症研究所批准的DSM， 计划特别委员会还促进和监测妇女和代表人数不足的少数民族参与， 临床研究促进少数群体参与临床研究的关键是 SCCC在其附属机构帕克兰健康和医院系统内提供和支持临床试验， 达拉斯县的安全网提供商CRO还与SCCC社区办公室合作 推广、参与和公平，以实施量身定制的战略，支持 代表性不足的少数民族。在整个生命周期中包含个人是最尖锐的证明 通过CRO在儿童医学中心的活动，这是北卡罗来纳州最大的儿科肿瘤学项目。 得克萨斯州，以及SCCC的特别注意，以尽量减少在所有临床试验的年龄限制。在当前 在癌症中心支持基金资助期间，SCCC取得了显著的临床研究进展。 亮点包括（1）自2014年以来，介入治疗应计费用增加了28%（2014年增加了48%）。 SCCC领导的药物启动的治疗试验），（2）研究激活时间缩短17%，（3） 与SCCC集水区人口统计学数据成比例的试验中种族/族裔少数的一致入组 （目前占干预性累积的34%），以及（4）承诺在整个生命周期内入组SCCC 在所有NCI儿童肿瘤组支持的机构中，应计费用最高的7%。

The Simmons Comprehensive Cancer Center (SCCC) Clinical Protocol and Data Management (CPDM) section reports information related to the (1) Clinical Research Office (CRO), (2) Data and Safety Monitoring Committee, (3) Inclusion of Women and Minorities in Clinical Research, and (4) Inclusion of Individuals Across the Lifespan in Clinical Research. These efforts, along with the Protocol Review and Monitoring System (PRMS), are closely monitored by the SCCC Clinical Cancer Research Committee, which is led by David E. Gerber, MD (Associate Director of Clinical Research). The CRO, under the leadership of M. Shaalan Beg, MD (CRO Medical Director) and Erin Williams, MBA (CRO Administrative Director), provides comprehensive, centralized services for the implementation and management of all oncology clinical research studies conducted at UT Southwestern Medical Center (UTSW) and its affiliated healthcare systems, Parkland Health and Hospital System and Children’s Medical Center. The CRO serves as the central repository for all cancer studies, maintains real-time reporting on research activities, and provides training and a library of standard operating procedures (SOPs) for all clinical research personnel. The Data and Safety Monitoring Committee (DSMC), led by Jonathan Dowell, MD, operates independently of the PRMS and CRO and conducts risk-based monitoring for adverse events and protocol compliance for all SCCC interventional trials. The DSMC is supported by a three-person Quality Assurance Unit that ensures the highest level of protocol compliance according to the SCCC’s National Cancer Institute–approved DSM Plan. SCCC also promotes and monitors the inclusion of women and underrepresented minorities in clinical research. Key to promoting underrepresented minority participation in clinical research is SCCC’s provision and support for clinical trials within its affiliate Parkland Health and Hospital System—the safety-net provider for Dallas County. The CRO also partners with the SCCC Office of Community Outreach, Engagement, and Equity to implement tailored strategies to support enrollment of underrepresented minorities. Inclusion of individuals across the lifespan is demonstrated most poignantly by the CRO’s activities at Children’s Medical Center, the largest pediatric oncology program in North Texas, as well as SCCC’s special attention to minimizing age restrictions in all clinical trials. In the current Cancer Center Support Grant funding period, SCCC has made notable clinical research progress. Highlights include (1) a 28% increase in interventional treatment accruals since 2014 (48% increase for SCCC-led investigator-initiated treatment trials), (2) a 17% reduction in time to study activation, (3) consistent enrollment of racial/ethnic minorities to trials proportional to SCCC catchment demographics (currently 34% of interventional accrual), and (4) a commitment to enrollment across the lifespan, with SCCC among the top 7% in accrual for all NCI Children’s Oncology Group–supported institutions.