Utah Trial Innovation Center

犹他州试验创新中心

• 批准号: 10208337
• 负责人: Jonathan Michael Dean
• 金额: $ 376.21万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10208337
• 关键词: Adopted; Adult; Advisory Committees; Agreement; Award; Budgets; Childhood; Clinical; Clinical Trials; Clinical and Translational Science Awards; Communication; Communities; Consent; Contracts; Critical Care; Devices; Diagnostic; Disease; Electronic Mail; Evolution; Funding; Health; Human; Information Systems; Informed Consent; Infrastructure; Institute of Medicine (U.S.); Institutional Review Boards; International; Investigational Drugs; Laboratory Study; Language; Leadership; Learning; Longevity; Measurement; Multicenter Studies; Multicenter Trials; National Institute of Child Health and Human Development; Nature; Office for Human Research Protections; Participant; Patients; Pediatrics; Performance; Pharmacology; Preventive Intervention; Principal Investigator; Procedures; Process; Protocols documentation; Rare Diseases; Recommendation; Registries; Research; Research Personnel; Research Support; Resources; Secure; Site; Standardization; System; Testing; Therapeutic; Translational Research; Translations; U-Series Cooperative Agreements; United States Food and Drug Administration; United States National Institutes of Health; Universities; Utah; Vision; Work; clinical center; clinical research site; experience; improved; innovation; payment; pediatric department; pharmacometrics; programs; protocol development; recruit; simulation; working group

Project Summary The NIH established the Clinical and Translational Science Award (CTSA) program in 2006 to enhance trans- lation of biomedical discoveries into therapeutic, diagnostic and preventive interventions to benefit patients and communities. In 2011, the CTSA Program became part of the National Center for Advancing Translational Sci- ences (NCATS). Assessment by the Institute of Medicine (IOM) in 2013, and recommendations from the NCATS Advisory Council Working Group in May 2014, have contributed to the vision that the consortium of CTSA Pro- grams should evolve into a collaborative national network to enable more efficient planning and implementation of high-quality multi-center research. NCATS began this evolution by requiring each CTSA Hub to actively partic- ipate in a developing national CTSA network (RFA-TR-14-009). NCATS is continuing the process by establishing Trial Innovation Centers (TICs) to accelerate implementation of multi-center studies by adding innovative network capacity to the existing strengths at the CTSA Hubs. The University of Utah proposes to be a TIC for the CTSA Network, with a focus on pediatrics, but capability across the lifespan. This proposal has three specific aims. Specific Aim 1. Provide immediate communication infrastructure for the TICs, RICs, NCATS, and CTSA investigators, and immediate capacity for NCATS to accept and assign trials on day 1, using our existing IT infrastructure, protocol development teams, functional reliance agreements and umbrella study contracts, central IRB procedures, budget templates, and capitation payment systems. Specific Aim 2. In the first six months, collaborate with the other TICs and the CTSA Network to standardize reliance agreement and contract language, consent templates, operating procedures, shared IT systems, innovative budgeting procedures, cIRB procedures, and performance measurement; and, subsequently implement a coordinated plan for securing agreements with all CTSA Hubs and their affiliates. Specific Aim 3. Using well-defined metrics to evaluate all trials supported by the three TICs and the two RICs, compare different strategies of trial planning, organization and implementation to identify and disseminate innovative ways to increase the quality and efficiency of multi-site clinical research. With our experience coordinating diverse multi-center trials across a broad range of diseases, the Trial Inno- vation Center at the University of Utah will provide immediate access to proven resources (electronic communica- tions, cIRB, protocol assistance, streamlined contracting and budgeting expertise) to accelerate the evolution of the CTSA Network. We will share our existing resources, learning about and adopting better resources from other Network participants. We are excited to have the opportunity to help realize the potential of the CTSA program as a national laboratory for studying, understanding, and improving multi-site translational research.

项目概要 美国国立卫生研究院 (NIH) 于 2006 年设立了临床与转化科学奖 (CTSA) 计划，旨在加强跨学科研究 将生物医学发现转化为治疗、诊断和预防干预措施，以造福患者和 社区。 2011 年，CTSA 项目成为国家转化科学促进中心的一部分。 恩斯（NCATS）。 2013 年医学研究所 (IOM) 的评估以及 NCATS 的建议 2014 年 5 月，咨询委员会工作组为 CTSA Pro 联盟的愿景做出了贡献 克应发展成为一个协作性的国家网络，以实现更有效的规划和实施 高质量的多中心研究。 NCATS 通过要求每个 CTSA 中心积极参与来开始这一演变 参与正在发展的国家 CTSA 网络 (RFA-TR-14-009)。 NCATS 正在通过建立 试验创新中心（TIC）通过增加创新网络加速多中心研究的实施 CTSA 中心的现有优势。 犹他大学提议成为 CTSA 网络的 TIC，重点关注儿科，但能力 贯穿整个生命周期。该提案有三个具体目标。具体目标 1. 提供即时沟通 TIC、RIC、NCATS 和 CTSA 调查员的基础设施，以及 NCATS 立即接受的能力 并在第一天分配试验，使用我们现有的 IT 基础设施、协议开发团队、功能依赖 协议和伞式研究合同、中央 IRB 程序、预算模板和按人头付费 系统。具体目标 2. 在前六个月内，与其他 TIC 和 CTSA 网络合作， 标准化信赖协议和合同语言、同意模板、操作程序、共享 IT 系统、创新预算程序、CIRB 程序和绩效衡量；并且，随后 实施协调计划，以确保与所有 CTSA 中心及其附属机构达成协议。具体目标 3. 使用明确定义的指标来评估三个 TIC 和两个 RIC 支持的所有试验，比较 试验规划、组织和实施的不同策略，以确定和传播创新方法 提高多中心临床研究的质量和效率。 凭借我们协调各种疾病的多中心试验的经验，试验创新 犹他大学的电子通信中心将提供对经过验证的资源的即时访问（电子通信） 系统、CIRB、协议协助、简化的合同和预算专业知识），以加速发展 CTSA 网络。我们将分享我们现有的资源，学习并采用其他更好的资源 网络参与者。我们很高兴有机会帮助实现 CTSA 计划的潜力 作为研究、理解和改进多地点转化研究的国家实验室。