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） 在斯蒂芬森癌症中心（SCC）工作，目标是支持SCC研究人员的设计， 以高效、合规和高效的方式开发、开展和报告临床研究的各个方面。 科学专注的方式。CTO员工执行监管和合规、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 履行职能，确保及时启动、进行和完成审判，并进行有效的质量控制和培训 功能协调发展的在过去的五年里，SCC已经累计了8，083名患者进行临床试验，其中包括2，531名患者。 1，015例入组干预性治疗，1，015例入组其他干预性试验，4，537例入组非干预性试验。的 SCC在NCTN介入治疗试验中累积的卓越记录导致其被指定为 2014年，NCTN领导学术参与网站（LAPS）。 SCC将确保参与临床试验的受试者的安全性和 从临床和转化研究中获得的数据质量。SCC具有书面数据和安全性 监查计划（DSMP），描述了对研究实施、受试者安全性和数据完整性的监督 对于SCC的所有临床试验，特别是对于IIT和DSMP尚未 存在.一个常设的需求侧管理委员会每季度举行一次会议，以履行这一重要的监测职能。 SCC高度重视招聘和留住妇女、少数民族和其他服务不足的人， 作为解决俄克拉荷马州重大癌症健康差异的一种方式。 SCC已制定了一些旨在实现这一目标的重点举措， 招募该州大量服务不足的美国印第安人（AI）参与临床试验。 SCC的人工智能患者导航计划已为来自54个不同部落的1，554名人工智能癌症患者提供了服务 在过去五年中，帮助343名AI患者入组介入治疗，263名非介入治疗。 干预性试验还实施了其他举措，以促进农村、贫困和弱势群体融入社会。 无保险，非裔美国人，西班牙裔，老年人和女性患者的临床试验。 SCC致力于将儿童（年龄小于21岁的受试者）纳入所有研究的NIH政策。 由NIH支持的适当临床研究。SCC儿科肿瘤学的主要目标 该部门正在招募和保留儿童参加临床试验，作为推进思想和 提高对这一人群的护理标准。该小组在设计中保持着积极的记录， 儿童肿瘤学小组（COG）和IIT进行儿科癌症临床试验，以实现 这个目标它一直在治疗试验招募的COG机构的前四分之一。