Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)

儿童和成人创新试验中心 (TRIDENT)

• 批准号: 9334376
• 负责人: DANIEL K. BENJAMIN
• 金额: $ 86.22万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9334376
• 关键词: Address; Adult; Agreement; Budgets; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Collection; Complement; Complex; Conduct Clinical Trials; Consent; Contracts Review; Country; Enrollment; Ensure; Funding; Funding Opportunities; Goals; Health; Infant; Informatics; Information Dissemination; Information Systems; Institution; Institutional Review Boards; Language; Learning; Measures; Methods; Monitor; Multi-Institutional Clinical Trial; Multicenter Trials; National Institute of Child Health and Human Development; Online Systems; Participant; Patients; Pediatrics; Principal Investigator; Process; Protocols documentation; Public Health; Records; Registries; Research; Research Design; Research Infrastructure; Research Institute; Research Methodology; Research Personnel; Research Support; Resources; Site; Time; Underserved Population; United States; United States National Institutes of Health; Universities; Vision; Work; biomedical informatics; collaborative trial; cost; design; human subject; improved; innovation; meetings; multi-site trial; novel; novel therapeutics; operation; programs; response; stem; success; trial design; web portal

ABSTRACT The conduct of clinical trials, particularly in infants and children, is complex, time consuming and expensive. Much of this inefficiency stems from slow and ineffective trial start-up and conduct. Duke University and Vanderbilt University propose to develop the Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT) to improve trial efficiencies, reduce the costs of multi-site clinical trials, optimize study quality, and in doing so, advance health in our country. Duke and Vanderbilt Universities are uniquely poised to establish the Trial Innovation Center (TIC) infrastructure in response to this CTSA funding opportunity. Duke will leverage the capacity, track record, and the pediatrics clinical trials program of the world’s largest Academic Research Organization, Duke Clinical Research Institute (DCRI), with Vanderbilt’s renowned biomedical informatics enterprise to meld high quality multi-center trial management with sophisticated informatics solutions supporting trial processes. Duke will capitalize on the world’s largest NIH-sponsored multicenter pediatric clinical trials program to support research in this underserved population. TRIDENT will not only transform trial quality and efficiency at CTSA sites, but will leverage TRIDENT infrastructure and resources to reach well beyond the CTSAs, given DCRI’s established site network throughout the world. To achieve this vision, we will establish three cores that will develop and implement innovative strategies across the design and conduct of trials. The Study Design core will use innovative methods and work directly with the CTSA Recruitment Innovation Centers and study investigators to develop robust protocols and feasible study budgets. The Study Start-up Core will engage interoperable IT systems, employ standardized study documents, assess site capabilities, establish Master Clinical Trial Agreements, facilitate e-consent, and oversee a central IRB thereby improving time to first participant enrolled. The Study Conduct core will then track study progress and quality, provide regulatory support, and develop materials to maximize public health impact. We will expand RedCap capabilities to facilitate collection of study documents via a web based portal, and collect, measure and act upon trial metrics. From the initial design of the trial until dissemination of the results, investigators will be partnered with operational and research methods experts. This partnership facilitates ongoing innovation via self-learning and frequent assessment. Key goals of this effort will be to implement a novel multi-site clinical trials platform combined with state of the art clinical trial operations to increase multi-site trial quality and efficiency across the CTSA.

抽象的 临床试验的进行，特别是在婴儿和儿童中，很复杂，耗时且昂贵。 这种低效率的大部分源于缓慢和无效的试验启动和行为。杜克大学和 范德比尔特大学（Vanderbilt University 为了提高试验效率，请降低多站点临床试验的成本，优化研究质量以及这样做， 在我国提高健康状况。杜克大学和范德比尔特大学（Duke and Vanderbilt）的大学被毒死 创新中心（TIC）基础设施应对CTSA资金机会。杜克将利用 世界最大的学术研究的能力，记录和儿科临床试验计划 杜克临床研究所（DCRI）的组织，范德比尔特（Vanderbilt）著名的生物医学Informati 企业将高质量的多中心试验管理与复杂的信息解决方案融合 支持试验过程。杜克大学将利用世界上最大的NIH赞助的多中心儿科 临床试验计划，以支持该服务不足的人群的研究。三叉戟不仅会改变审判 CTSA网站的质量和效率，但将利用三叉戟基础架构和资源来达到良好 除了CTSA之外，鉴于DCRI在世界各地建立的现场网络。为了实现这一愿景，我们将 建立三个核心，将在整个设计和行为中制定和实施创新策略 试验。研究设计核心将使用创新方法，并直接与CTSA招聘合作 创新中心和研究研究人员制定了强大的协议和可行的研究预算。研究 启动核心将接触可互操作的IT系统，员工标准化的研究文件，评估网站 功能，建立临床临床试验协议，促进电子综合，并监督中心IRB 提高了首先参加的参加时间。然后，研究进行核心将跟踪研究进度和质量， 提供监管支持，并开发材料以最大程度地提高公共卫生影响。我们将扩展Redcap 通过基于Web的门户来促进研究文档的能力，并收集，衡量和ACT 在试用指标上。从试验的最初设计直到结果传播，研究人员将是 与运营和研究方法专家合作。这种伙伴关系通过 自学和经常评估。这项工作的关键目标将是实施新型的多站点临床 试验平台结合了最先进的临床试验操作，以提高多站点试验质量和 整个CTSA的效率。