Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC)

与试验加速、信任、创新和能力合作站点合作 (ECSTATIC)

• 批准号: 10650682
• 负责人: Gordon R Bernard
• 金额: $ 516.98万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-29 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10650682
• 关键词: Acceleration; Adopted; Adoption; Agreement; Biometry; Budgets; Businesses; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Network; Collaborations; Compensation; Complex; Contracts; Data; Data Collection; Data Coordinating Center; Disease; Doctor of Philosophy; Elasticity; Electronic Health Record; Electronics; Ensure; Epidemiology; Funding; Growth; Health; Historically Black Colleges and Universities; Human; Image; Infrastructure; Institution; Institutional Review Boards; Learning; Methodology; Methods; Monitor; Multi-Institutional Clinical Trial; Participant; Phenotype; Population; Procedures; Process; Productivity; Readiness; Recording of previous events; Reporting; Reproducibility; Research; Research Design; Resources; Risk; Rural; Seasons; Services; Shapes; Site; Structure; System; Testing; Time; Touch sensation; Training; Trust; Work; biobank; clinical research site; cohort; community engagement; cost; data management; data standards; electronic consent; health care delivery; health equity; improved; innovation; interest; meetings; multi-site trial; novel; practice-based research network; programs; randomized, clinical trials; recruit; support tools; tool; trial design; virtual

Clinical research comes in many different shapes and sizes, and a robust network must accommodate all trial types. No single organization can do this work alone. We have a deep commitment to both trial innovation and collective network capacity within and beyond the CTSA Consortium and have a lengthy history of supporting this approach. We have demonstrated an exceptional ability to collaboratively innovate and share tools supporting clinical research coordination, including: global data management, mobile data collection, recruitment, Electronic Health Record (EHR) research, single IRB coordination, contracting, community engagement, returning value to participants, eConsent, virtual/remote participation in studies, and EHR integration with REDCap. We will leverage and expand upon these programs as we are Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC). We will establish a distributed alliance of 6 CTSA-aligned coordinating centers to add elastic capacity and broaden expertise to the TIN’s CCC/DCC infrastructure. Our alliance has 14 expert trialists that can inform the use of integrated approaches for more efficient clinical research. Additionally, we will partner with the well-established Biostatistics, Epidemiology, and Research Design (BERD) group and health equity experts to ensure every study has access to needed expertise starting from study design through analysis. We will broaden the types of organizations that can readily participate in clinical research across the U.S., including Historically Black Colleges and Universities (HBCUs), to reach the populations most in need of support. Based on our novel structure, merging teams from six different coordinating center groups, our TIC’s capacity is both scalable and matched by expertise to intentionally accommodate all study design types. Led by Gordon Bernard, MD, Wesley Self, MD, and Christopher Lindsell, PhD, each seasoned in leading and collaborating with multisite clinical trial networks, ECSTATIC will embrace and draw on diverse expertise to build, test, and share new resources that will enhance and accelerate rigorous, reproducible research for all CTSAs, to more rapidly improve human health. Our Specific Aims are to: 1) demonstrate and disseminate novel integrated approaches for more efficient clinical research including EHR-embedded, remote no-touch, and platform trials, aligning with study needs; 2) expand and enrich clinical trial capability by increasing potential participating site Expression of Interest (EOI) reach and readiness support (HBCUs and rural Practice-Based Research Networks), better process integration with CTSAs, preparing study teams, and broader expert engagement; 3) innovate clinical trial methodology by creating, evaluating, and disseminating new methods for risk monitoring, AE reporting, direct EHR to REDCap data capture, and data standards to all CTSAs; and 4) provide a distributed alliance of clinical and data coordinating centers with extensive and diverse expertise to offer support tailored for trial design, population, and condition.

临床研究有许​​多不同的形状和大小，强大的网络必须适应所有试验 类型。没有一个组织可以独自完成这项工作。我们对两个试用创新都有深厚的承诺 以及CTSA财团内外的集体网络能力，并具有悠久的历史 支持这种方法。我们已经证明了与协作无效和分享的非凡能力 支持临床研究协调的工具，包括：全球数据管理，移动数据收集， 招聘，电子健康记录（EHR）研究，单一IRB协调，签约，社区 参与，对参与者的返回价值，依恋，虚拟/远程参与研究和EHR 与Redcap集成。当我们参与合作社时，我们将利用和扩展这些计划 试验加速，信任，创新和能力的站点（狂喜）。我们将建立一个分布式 6个CTSA一致的协调中心的联盟，以增加弹性能力并扩大专业知识 CCC/DCC基础架构。我们的联盟有14位专家审判员，可以告知综合方法的使用 进行更有效的临床研究。此外，我们将与公认的生物统计学合作， 流行病学，研究设计（BERD）小组和健康权益专家，以确保每个研究都有 从研究设计开始到分析，获得所需的专业知识。我们将扩大类型 可以容易参与美国临床研究的组织，包括历史黑人 学院（HBCUS），以达到最需要支持的人群。基于我们的小说 结构，合并来自六个不同协调中心组的团队，我们的TIC的能力都是可扩展的 并以专业知识匹配，以有意接受所有研究设计类型。由戈登·伯纳德（Gordon Bernard）领导 MD，Wesley Self，医学博士和Christopher Lindsell博士，每个人都在领导并与 多场地临床试验网络，狂喜将拥抱和利用潜水员专业知识来建立，测试和分享 新资源将增强和加速所有CTSA的严格，可重复的研究，以更快地 改善人类健康。我们的具体目的是：1）演示和传播新颖的整合 采用更有效的临床研究的方法 试验，与研究需求保持一致； 2）扩大和丰富临床试验能力，通过提高潜力 参与现场的兴趣表达（EOI）覆盖范围和准备就绪支持（HBCUS和基于粗糙的实践 研究网络），与CTSA的更好的过程集成，准备研究团队以及更广泛的专家 订婚; 3）通过创建，评估和传播新方法来创新临床试验方法 为了进行风险监控，AE报告，将EHR直接用于REDCAP数据捕获以及所有CTSA的数据标准；和 4）提供广泛而潜水的专业知识，提供临床和数据协调中心的分布式联盟 提供针对试验设计，人口和状况的支持。