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.

摘要 俄克拉荷马州大学健康科学中心（OUHSC）的斯蒂芬森癌症中心（SCC） 在为俄克拉荷马州人提供进入国家临床试验网络（NCTN）和其他 临床试验，从而有助于提高国家和地区的护理标准。在国家一级 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 在NCTN中被指定为主要学术参与研究中心（LAPS）。从那时起，它一直致力于 推进以下具体目标：（1）提供科学的领导和协调与NCTN 为新开发的疗法设计和进行NCTN临床试验的组成部分，包括多模态 治疗、新型药物组合、基于分子的治疗、精准医学筛选，以及 先进的成像方法;（2）有效地整合科学专业知识和临床试验管理 SCC的能力，以便以高效，及时和 （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州人提供NCTN临床试验，特别强调该州服务不足的人群 这些人群经历了不成比例的癌症健康差异。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 在NCTN和其他临床试验中招募患者。具体而言，SCC实施了创新的 美国印第安人（AI）患者导航计划，以服务于俄克拉荷马州的大量AI人口，并促进 NCTN和其他临床试验的招募在临床研究中代表性不足。 SCC的临床研究活动由明确的治理结构监督，并得到 集中式临床试验办公室（CTO），负责管理法规、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。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， 使其能够积极主动地参与教职员工的教育和职业发展，并提高 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 在各级研究活动中配备足够的人员和知识，并确保协调的研究团队 临床研究的方法。SCC是NRG肿瘤学的主要投票成员， 它是SWOG和ECOG-ACRIN癌症研究小组的正式成员。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。