Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)

摘要 进行临床试验，特别是在婴儿和儿童中进行临床试验，是复杂、耗时和昂贵的。 这种低效率在很大程度上是由于审判的启动和进行缓慢和无效。杜克大学和 范德比尔特大学提议建立儿童和成人创新试验中心（TRIDENT） 为了提高试验效率，降低多中心临床试验的成本，优化研究质量，并在此过程中， 提高我国的健康水平。杜克大学和范德比尔特大学是独一无二的准备建立审判 创新中心（TIC）的基础设施，以应对这一CTSA资助机会。杜克会利用 能力，跟踪记录，和儿科临床试验计划的世界上最大的学术研究 组织，杜克临床研究所（DCRI），与范德比尔特著名的生物医学信息学 将高质量的多中心试验管理与复杂的信息化解决方案相结合 支持审判流程。杜克将利用世界上最大的国家卫生研究院赞助的多中心儿科 临床试验计划，以支持在这一服务不足的人群的研究。TRIDENT不仅会改变审判 质量和效率，但将利用TRIDENT基础设施和资源， 鉴于DCRI在世界各地建立的站点网络，为了实现这一愿景，我们将 建立三个核心，将制定和实施创新战略的设计和进行 审判研究设计核心将使用创新方法，并直接与CTSA招聘部门合作 创新中心和研究者制定稳健的方案和可行的研究预算。研究 启动核心将采用可互操作的IT系统，采用标准化的研究文件，评估现场 能力，建立主临床试验协议，促进电子同意，并监督中央IRB，从而 缩短了第一个参与者登记的时间。然后，研究行为核心将跟踪研究进度和质量， 提供监管支持，并开发材料，以最大限度地提高公共卫生影响。我们将扩大RedCap 能够通过基于网络的门户网站促进研究文件的收集，并收集、测量和采取行动 在试用指标上。从试验的初始设计到结果的传播，研究者将 与业务和研究方法专家合作。这种伙伴关系通过以下方式促进持续创新： 自学和经常评估。这项工作的主要目标将是实施一种新的多中心临床 试验平台与最先进的临床试验操作相结合，以提高多中心试验质量， CTSA的效率。

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.