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.

临床研究有多种不同的形式和规模，强大的网络必须适应所有试验 没有任何一个组织可以单独完成这项工作，我们对这两种试验创新都有坚定的承诺。 CTSA 联盟内部和外部的集体网络容量，并且具有悠久的历史 我们展示了协作创新和共享的卓越能力。 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、承包、社区 参与、向参与者返还价值、电子同意、虚拟/远程参与研究以及 EHR 我们将在参与合作时利用并扩展这些计划。 我们将建立一个分布式试验加速、信任、创新和能力站点（ECSTATIC）。 由 6 个 CTSA 协调中心组成的联盟，旨在为 TIN 增加弹性能力并拓宽专业知识 CCC/DCC 基础设施我们的联盟拥有 14 名专家试验员，可以为综合方法的使用提供信息。 此外，我们将与成熟的生物统计学合作， 流行病学和研究设计 (BERD) 小组和健康公平专家确保每项研究都符合 从研究设计到分析，获取所需的专业知识。 可以轻松参与美国各地临床研究的组织，包括 Historically Black 学院和大学 (HBCU)，为最需要支持的人群提供服务 根据我们的小说。 结构，合并来自六个不同协调中心组的团队，我们的TIC的能力是可扩展的 并配备专业知识，有意适应由戈登·伯纳德 (Gordon Bernard) 领导的所有研究设计类型， 医学博士、Wesley Self 医学博士和 Christopher Lindsell 博士，每个人都具有领导和合作的经验 多站点临床试验网络，ECSTATIC 将拥抱并利用不同的专业知识来构建、测试和共享 新资源将增强和加速所有 CTSA 的严格、可重复的研究，以更快地实现 改善人类健康我们的具体目标是：1）展示和传播新颖的综合方法。 更高效临床研究的方法，包括嵌入式 EHR、远程非接触式和平台 试验，与研究需求保持一致；2）通过增加潜力来扩大和丰富临床试验能力 参与地点意向书 (EOI) 覆盖范围和准备支持（HBCU 和农村基于实践的 研究网络）、与 CTSA 更好的流程集成、准备研究团队和更广泛的专家 3）通过创建、评估和传播新方法来创新临床试验方法 用于风险监控、AE 报告、直接 EHR 到 REDCap 数据采集以及所有 CTSA 的数据标准； 4) 提供具有广泛和多样化专业知识的临床和数据协调中心的分布式联盟 提供针对试验设计、人群和条件量身定制的支持。