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式和规模，一个强大的网络必须容纳所有的试验