Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9924333
• 负责人: Kathleen N. Moore
• 金额: $ 22.86万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9924333
• 关键词: 21 year old; Address; African American; American Indians; Cancer Center; Cancer Center Support Grant; Cancer Patient; Catchment Area; Child; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Conduct Clinical Trials; Data; Development; Elderly; Enrollment; Ensure; Female; Goals; Hispanics; Information Systems; Institutes; Institution; Intervention; Lead; Malignant Childhood Neoplasm; Minority; Monitor; Nursing Research; Oklahoma; Participant; Patient-Focused Outcomes; Patients; Pediatric Oncology; Pediatric Oncology Group; Policies; Population; Quality Control; Reporting; Research; Research Personnel; Research Support; Risk; Rural; Rural Population; Safety; Services; Site; Therapeutic Trials; Time; Training; Translational Research; Tribes; Underserved Population; Uninsured; United States National Institutes of Health; Woman; base; cancer clinical trial; cancer health disparity; clinical trial participant; data integrity; data management; design; efficacy clinical trial; improved; improved outcome; participant safety; programs; recruit; safety study; sound; standard of care; treatment trial

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.

临床方案和数据管理 – 摘要 集中的临床试验办公室 (CTO) 负责监督所有临床方案和数据管理 (CPDM) 斯蒂芬森癌症中心 (SCC) 的职能，旨在支持 SCC 研究人员的设计、 以高效、合规和可靠的方式开发、开展和报告临床研究的各个方面 CTO 员工负责监管与合规、数据管理、研究 护理和研究协调、信息系统和数据支持、研究财务和行政支持 通过有效的质量控制和培训确保试验的及时启动、进行和完成 过去五年来，SCC 已累计接受临床试验的患者 8,083 名，其中 2,531 名。 介入治疗入组人数、其他介入试验入组人数 1,015 人、非介入试验入组人数 4,537 人。 SCC 在 NCTN 介入治疗试验中的卓越记录使其被指定为 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和 从临床和转化研究中获得的数据的质量 SCC 有书面的数据和安全性。 监控计划 (DSMP)，描述研究行为、参与者安全和数据完整性的监督 适用于 SCC 的所有临床试验，特别是 IIT 和 DSMP 尚未进行的那些研究 存在一个常设 DSM 委员会，每季度召开一次会议，以履行这一重要的监督职能。 SCC 高度重视招聘和保留女性、少数族裔和其他服务不足的人员 人口参与临床试验作为解决俄克拉荷马州重大癌症健康差异的一种方式。 SCC 制定了一系列旨在实现这一目标的重点举措，其中特别关注 招募该州大量且服务不足的美洲印第安人 (AI) 人口参与临床试验。 SCC 的 AI 患者导航计划已为来自 54 个不同部落的 1,554 名 AI 癌症患者提供服务 过去五年，帮助促进了 343 名人工智能患者入组介入治疗和 263 名非治疗患者入组 还实施了其他举措来促进农村、贫困和贫困人口的融入。 接受临床试验的无保险患者、非裔美国人、西班牙裔患者、老年患者和女性患者。 SCC 致力于遵守 NIH 政策，将儿童（21 岁以下的受试者）纳入所有研究项目 NIH 支持的适当临床研究是 SCC 儿科肿瘤学的主要目标。 该部门正在招募和留住儿童参与临床试验，以此作为推进想法和发展的一种方式。 提高该人群的护理标准 该小组在设计和实施方面保持着积极的记录。 儿童肿瘤学组 (COG) 和 IIT 开展儿科癌症临床试验，以完成 它在治疗试验注册方面一直位居 COG 机构前四分之一。