Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10177898
• 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
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10177898
• 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.

临床协议和数据管理 - 摘要 集中式临床试验办公室（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，目的是支持SCC研究人员的设计， 在有效，合规和 科学专注的方式。 CTO员工执行监管和合规性，数据管理，研究 护理和研究协调，信息系统和数据支持，研究融资和管理员支持 功能以确保及时开始，进行和完成试验，并有效地控制和培训 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例 介入治疗的入学率，1,015次其他介入，4,537例非介入试验。这 SCC对NCTN介入治疗试验准确性的出色记录导致其被指定为 NCTN领导学术参与地点（LAPS）2014年。 SCC在确保参与临床试验的受试者的安全和 从临床和翻译研究中获得的数据质量。 SCC具有书面数据和安全性 监视计划（DSMP），描述了研究行为的监督，参与数据的安全性和完整性 对于SCC的所有临床试验，特别是对于IIT和DSMP尚未进行的研究 存在。常设的DSM委员会每季度开会，以履行这一重要的监控功能。 SCC在招募和保留妇女，少数民族和其他服务不足的招聘和保留方面将高度重视 临床试验参与的人群是解决俄克拉荷马州重大癌症健康分布的一种方法。 SCC制定了许多旨在实现这一目标的专注举措，特别是 招募该州的大型和服务不足的美洲印第安人（AI）人群进行临床试验。 SCC的AI患者导航计划为来自54个不同部落的1,554例AI癌症患者提供了服务 过去五年，有助于促进343名AI患者进行介入，263例 介入试验。已经实施了其他举措，以促进农村，不足和 未投保的非裔美国人，西班牙裔，老年人和女性患者进行了临床试验。 SCC致力于将儿童（小于21岁的受试者）包括在内的NIH政策 NIH支持的适当临床研究。 SCC小儿肿瘤学的主要目标 部门正在招募和留下儿童参加临床试验，以推进思想和 提高为该人群的护理标准。该小组在设计中保持了积极的记录和 儿童肿瘤学组（COG）和IIT的小儿癌临床试验的进行 这个目标。它一直在COG机构的顶级四分位数中，从事治疗试验的入学。