Utah Trial Innovation Center

犹他州试验创新中心

• 批准号: 10010119
• 负责人: Jonathan Michael Dean
• 金额: $ 553.24万
• 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/10010119
• 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 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.

项目摘要 美国国立卫生研究院于2006年设立了临床和转化科学奖（CTSA）计划，以提高跨 将生物医学发现转化为治疗、诊断和预防干预措施，使患者贝内， 社区. 2011年，CTSA计划成为国家推进翻译科学中心的一部分， （NCATS）。2013年医学研究所（IOM）的评估和NCATS的建议 咨询理事会工作组在2014年5月，作出了贡献的愿景，CTSA专业联盟- gram应该发展成为一个合作性的国家网络，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，开始了这一演变。 在发展中的国家CTSA网络（RFA-TR-14-009）中进行ipate。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。 犹他州大学提议成为CTSA网络的TIC，重点是儿科，但能力 在生命的各个阶段。这项建议有三个具体目标。具体目标1.提供即时通信 为TIC、RIC、NCATS和CTSA调查人员提供基础设施，以及NCATS接受 并在第一天分配试验，使用我们现有的IT基础设施，方案开发团队，功能依赖 协议和总括研究合同、中心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，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，创新的预算程序，cIRB程序和绩效衡量;以及，随后 实施协调计划，确保与所有CTSA中心及其附属机构达成协议。具体目标 3.使用定义明确的指标评估三个TIC和两个RIC支持的所有试验，比较 审判规划、组织和实施的不同战略，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。 凭借我们协调广泛疾病的多样化多中心试验的经验，试验创新- 犹他州大学的vation中心将提供对经过验证的资源（电子通信）的即时访问， cIRB、方案协助、简化的合同和预算专业知识），以加速 CTSA网络。我们将分享我们现有的资源，学习和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 作为一个国家实验室，研究，理解和改进多站点转化研究。