Clinical Protocol and Data Management

临床方案和数据管理.摘要 一个集中的临床试验办公室(CTO)监督所有临床方案和数据管理(CPDM) 斯蒂芬森癌症中心(SCC)的功能，目的是在设计中支持SCC调查人员， 以高效、合规和安全的方式开发、实施和报告临床研究的所有方面 科学专注的态度。CTO员工执行法规和合规、数据管理、研究 护理和研究协调、信息系统和数据支持、研究资金和行政支持 确保通过有效的质量控制和培训及时启动、进行和完成试验的职能 功能。在过去的五年中，SCC积累了8,083名患者进行临床试验，其中包括2,531名患者 参加介入治疗的人数为1015人，参加其他干预试验的人数为1015人，参加非干预试验的人数为4537人。这个 SCC在NCTN介入治疗试验中的出色记录导致其被指定为 2014年NCTN领先学术参与网站(LAPS)。 SCC将确保参与临床试验的受试者的安全放在首位，并将 从临床和转化性研究中获得的数据质量。SCC有书面数据和安全 监控计划(DSMP)，描述对研究行为、参与者安全和数据完整性的监督 用于SCC的所有临床试验，特别是针对IITs和那些尚未通过DSMP的研究 是存在的。电力需求侧管理常设委员会每季度举行一次会议，以履行这一重要的监测职能。 委员会高度重视招募和留住妇女、少数群体和其他未得到充分服务的人。 参与临床试验的人群，作为解决俄克拉荷马州显著的癌症健康差距的一种方式。 SCC制定了一些有重点的举措，旨在实现这一目标，并有特别的重点 关于招募该州庞大且服务不足的美国印第安人(AI)人口参加临床试验。 SCC的人工智能患者导航计划已经为来自54个不同部落的1554名人工智能癌症患者提供了服务 过去五年，帮助促进343名AI患者加入干预组，263名加入非干预组 干预性试验。还实施了其他倡议，以促进将农村、儿童和儿童纳入 未参保的、非裔美国人、西班牙裔、老年和女性患者正在进行临床试验。 SCC致力于NIH的政策，将所有儿童(21岁以下的受试者)包括在内 由美国国立卫生研究院支持的适当临床研究。SCC儿科肿瘤学的首要目标 卫生部正在招募和留住儿童参加临床试验，以此作为推动想法和 提高对这一人群的护理标准。该小组在设计中保持了活跃的记录，并 开展儿童癌症临床试验，儿童肿瘤学小组(COG)和IIT，以完成 这个目标。它一直是COG机构登记参加治疗试验的前四分位数。

CLINICAL PROTOCOL AND DATA MANAGEMENT – ABSTRACT A centralized Clinical Trials Office (CTO) oversees all Clinical Protocol and Data Management (CPDM) functions at the Stephenson Cancer Center (SCC), with the goal of supporting SCC investigators in the design, development, conduct and reporting of all aspects of clinical research in an efficient, compliant and scientifically focused manner. CTO staff perform regulatory and compliance, data management, research nursing and study coordination, information systems and data support, research finance, and admin support functions to ensure timely initiation, conduct and completion of trials with effective quality control and training functions. Over the past five years, the SCC has accrued 8,083 patients to clinical trials, including 2,531 enrollments to interventional treatment, 1,015 to other interventional and 4,537 to non-interventional trials. The SCC's exceptional track record of accrual to NCTN interventional treatment trials led to its being designated an NCTN Lead Academic Participating Site (LAPS) in 2014. The SCC places the highest priority on ensuring the safety of subjects participating in clinical trials and on the quality of data obtained from clinical and translational research. The SCC has a written Data and Safety Monitoring Plan (DSMP) that describes the oversight of study conduct, participant safety and integrity of data for all clinical trials at the SCC, and particularly for IITs and those studies for which a DSMP does not already exist. A standing DSM Committee meets quarterly to fulfill this important monitoring function. The SCC places a high priority on the recruitment and retention of women, minorities and other underserved populations for clinical trial participation as a way to address Oklahoma's significant cancer health disparities. The SCC has instituted a number of focused initiatives designed to accomplish this aim, with a particular focus on recruiting the state's large and underserved American Indian (AI) population for clinical trial participation. The SCC's AI Patient Navigation Program has served 1,554 AI cancer patients from 54 different tribes over the past five years, helping to facilitate the enrollment of 343 AI patients to interventional and 263 to non- interventional trials. Other initiatives have been implemented to promote the inclusion of rural, under- and uninsured, African American, Hispanic, elderly and female patients on clinical trials. The SCC is committed to the NIH Policy of including children (subjects less than 21 years of age) in all appropriate clinical research supported by the NIH. A primary goal of the SCC's Pediatric Oncology Department is recruiting and retaining children to participate in clinical trials as a way of advancing ideas and raising the standard of care for this population. This group has maintained an active record in the design and conduct of pediatric cancer clinical trials, both the Children's Oncology Group (COG) and IIT, to accomplish this goal. It has consistently been in the top quartile of COG institutions for enrollment in therapeutic trials.