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: 10582583
• 负责人: Kathleen N. Moore
• 金额: $ 187.1万
• 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/10582583
• 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; Eligibility Determination; Enrollment; Ensure; Extramural Activities; Faculty; Funding; Goals; Grant; Health Sciences; 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; 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; participant enrollment; patient navigation; patient navigator; 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.

抽象的 俄克拉荷马大学健康科学中心 (OUHSC) 的史蒂芬森癌症中心 (SCC) 发挥作用 在为俄克拉荷马人提供国家临床试验网络 (NCTN) 和其他服务方面发挥着至关重要的作用 临床试验，从而有助于提高国家和地区的护理标准。在国家层面， 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 的主要学术参与站点 (LAPS)。从那时起，它一直致力于 推进以下具体目标： (1) 提供科学领导并与 NCTN 协调 为新开发的疗法（包括多模式）设计和进行 NCTN 临床试验的组件 治疗、新药组合、分子治疗、精准医学筛选，以及 先进的成像方法； (2)科学专业知识与临床试验管理的有效结合 SCC 的能力，以便高效、及时和完成 NCTN 临床试验 合规的方式； (3) 在提供高质量癌症护理的背景下实现目标 1 和 2 并为所有俄克拉荷马人提供 NCTN 临床试验的机会，特别强调该州服务不足的地区 癌症健康差异比例过高的人群。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。具体来说，SCC 实施了一项创新 美洲印第安人 (AI) 患者导航计划旨在为俄克拉荷马州庞大的 AI 人口提供服务并促进 该人群参加 NCTN 和其他临床试验的人数在临床研究中代表性不足。 SCC 的临床研究活动受到明确的治理结构的监督，并得到 集中的临床试验办公室 (CTO)，负责管理监管、数据管理、研究协调、 所有癌症临床试验的信息学、质量保证和生物样本采集。 CTO 的职责是 核心资源，除了临床试验直接成本之外，还从各种来源获得资金， 使其能够积极主动地参与教职员工的教育和职业发展，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 各级研究活动拥有充足的人员配备和知识，并确保研究团队协调一致 临床研究方法。 SCC 是 NRG 肿瘤学和肿瘤联盟的主要投票成员 肿瘤学临床试验，是SWOG和ECOG-ACRIN癌症研究组的正式成员。它 与各自的网络集团运营、数据管理和 统计中心以实现赠款的具体目标。