A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical Trials

俄克拉荷马州设计和进行 NCTN 临床试验的主要学术参与中心

• 批准号: 9889077
• 负责人: Kathleen N. Moore
• 金额: $ 177.22万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-07 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9889077
• 关键词: Address; Advisory Committees; American College of Radiology Imaging Network; American Indians; Authorship; Cancer Burden; Cancer Center; Cancer Patient; Clinical Research; Clinical Trials; Clinical Trials Network; Combined Modality Therapy; Direct Costs; Disease; Eastern Cooperative Oncology Group; Education; Enrollment; Ensure; Extramural Activities; Faculty; Funding; Goals; Grant; Health Sciences; Health Services Accessibility; Incidence; Informatics; Information Dissemination; Knowledge; Lead; Leadership; Malignant Neoplasms; Molecular; National Clinical Trials Network; Office Management; Oklahoma; Oncology; Outcome; Patient-Focused Outcomes; Patients; Phase; Play; Population; Public Health; Publications; Randomized; Research; Research Activity; Research Design; Research Infrastructure; Research Personnel; Resources; Role; Rural; Site; Social Workers; Source; Southwest Oncology Group; Structure; Time; Training; Underinsured; Underrepresented Populations; Underserved Population; Uninsured; Universities; Voting; Work; anticancer research; base; cancer care; cancer clinical trial; cancer health disparity; career development; clinical care; clinical research site; data management; data submission; design; experience; imaging approach; improved; innovation; knowledge base; meetings; member; mortality; multidisciplinary; novel; operation; organizational structure; precision medicine; programs; protocol development; quality assurance; screening; standard of care; statistical center; therapy development; working group

Abstract The Stephenson Cancer Center (SCC) at the University of Oklahoma Health Sciences Center (OUHSC) plays a crucial role in providing Oklahomans with access to National Clinical Trials Network (NCTN) and other clinical trials, thereby helping to raise the standard of care in the State and region. At the national level, the SCC has provided significant leadership in the design and conduct of NCTN clinical trials. In 2014, the SCC was designated a Lead Academic Participating Site (LAPS) in the NCTN. Since that time, it has worked to advance the following Specific Aims: (1) providing scientific leadership and coordination with NCTN components to design and conduct NCTN clinical trials for newly developed therapies, including multi-modality treatments, combinations of novel agents, molecularly based treatments, Precision Medicine screening, and advanced imaging approaches; (2) effectively integrating scientific expertise and clinical trials management capabilities at the SCC in order to activate, conduct and complete NCTN clinical trials in an efficient, timely and compliant manner; and (3) accomplishing Aims 1 and 2 within the context of providing high-quality cancer care and access to NCTN clinical trials for all Oklahomans, with a special emphasis on the State's underserved populations which experience disproportionately high rates of cancer health disparities. To advance Aim 3, the SCC utilizes patient navigators, social workers and targeted educational information to address barriers to enrolling patients on NCTN and other clinical trials. Specifically, the SCC has implemented an innovative American Indian (AI) Patient Navigation program to serve the Oklahoma's large AI population and promote enrollment to NCTN and other clinical trials for this population under-represented in clinical research. Clinical research activities at the SCC are overseen by a well-defined governance structure and supported by a centralized Clinical Trials Office (CTO) that manages regulatory, data management, study coordination, informatics, quality assurance, and biospecimen acquisition for all cancer clinical trials. The CTO functions as a core resource and receives funding from a variety of sources in addition to clinical trial direct cost dollars, allowing it to be proactive in faculty and staff education and career development, and leading to enhanced expertise and support capabilities. The collective knowledge base and cross-training within the CTO allows for adequate staffing and knowledge at all levels of research activity and ensures a coordinated research team approach for clinical research. The SCC is a Main Voting Member for NRG Oncology and the Alliance for Clinical Trials in Oncology, and it is a Full Member of SWOG and ECOG-ACRIN Cancer Research Group. It has worked efficiently and expeditiously with the respective Network Group operations, data management, and statistical centers to accomplish the Specific Aims of the grant.

摘要 俄克拉荷马大学健康科学中心的斯蒂芬森癌症中心(SCC)发挥了作用 在为俄克拉荷马州人提供访问国家临床试验网络(NCTN)和其他 临床试验，从而帮助提高国家和地区的护理标准。在国家层面上， SCC在NCTN临床试验的设计和实施方面发挥了重要的领导作用。2014年，SCC 被指定为NCTN的领先学术参与站点(LAPS)。从那时起，它一直在发挥作用 推进以下具体目标：(1)为国家技术合作网络提供科学的领导和协调 为新开发的疗法设计和进行NCTN临床试验的组件，包括多模式 治疗，新药物的组合，基于分子的治疗，精确药物筛选，以及 先进的成像方法；(2)有效整合科学专业知识和临床试验管理 SCC的能力，以便高效、及时和高效地激活、进行和完成NCTN临床试验 (3)在提供高质量癌症护理的背景下实现目标1和目标2 并为所有俄克拉荷马州人提供NCTN临床试验，特别强调该州服务不足的人 癌症健康差距高得不成比例的人群。为了推进目标3， SCC利用患者导航员、社会工作者和有针对性的教育信息来解决障碍 招募患者参加NCTN和其他临床试验。具体地说，SCC实施了创新的 美国印第安人(AI)患者导航计划，服务于俄克拉荷马州庞大的AI人群并促进 参加NCTN和其他临床试验的这一人群在临床研究中的代表性不足。 SCC的临床研究活动由定义良好的治理结构监督，并由 集中临床试验办公室(CTO)管理监管、数据管理、研究协调、 为所有癌症临床试验提供信息学、质量保证和生物素采集。首席技术官的职能是 核心资源，除了临床试验直接成本美元外，还从各种来源获得资金， 使其在教职员工教育和职业发展方面积极主动，并导致增强 专业知识和支持能力。CTO内部的集体知识库和交叉培训允许 在所有级别的研究活动中配备充足的人员和知识，并确保协调研究团队 临床研究的方法。SCC是NRG肿瘤学和 肿瘤学临床试验，是SWOG和ECOG-ACRIN癌症研究小组的正式成员。它 高效、快速地与各自的网络组运营、数据管理和 统计中心完成了赠款的具体目标。