Renewal of The Mid-America CTSA Consortium (MACC) as a Regional Clinical Center for SIREN

更新中美洲 CTSA 联盟 (MACC) 作为 SIREN 的区域临床中心

• 批准号: 10550446
• 负责人: TOM Paul AUFDERHEIDE
• 金额: $ 47.36万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10550446
• 关键词: Adult; Agreement; Applications Grants; Budgets; Chicago; Clinical Trials; Clinical Trials Network; Collaborations; Contracts; Educational Curriculum; Emergency Care; Emergency Situation; Enrollment; Faculty; Fellowship; Funding; Goals; Grant; Health; Helicopter; Hospitals; Illinois; Indiana; Infrastructure; Institution; Intervention; Investments; K-Series Research Career Programs; Leadership; Life; Location; Medical center; Medicine; Mentors; Mentorship; Methodist Church; Methods; Patients; Pediatric Hospitals; Performance; Persons; Politics; Population Heterogeneity; Positioning Attribute; Qualifying; Quality of life; Recommendation; Recording of previous events; Research; Research Design; Research Personnel; Retirement; Secure; Site; Social Sciences; Structure; Study Subject; System; Testing; Texas; Time; Training; Underserved Population; United States National Institutes of Health; Universities; Wisconsin; career; clinical care; clinical center; design; dissemination strategy; experience; improved; innovation; medical schools; multidisciplinary; patient retention; recruit; screening; working group

The Mid-America CTSA Consortium (MACC) submits this renewal application to continue as a Regional Clinical Center (RCC) for the “Strategies to Innovate EmeRgENcy Care Clinical Trials” (SIREN) Network (RFA-NS-22-015). Because Dr. Aufderheide (previous Contact PI at the Medical College of Wisconsin [MCW] Hub) has announced his retirement on January 1, 2024, and because his replacement is unknown at the time of grant submission, we propose to transfer the MACC Hub from MCW to the University of Chicago Medicine (UCM) and Contact PI status to David Beiser, MD, MS (UCM) proactively. As recommended by the NIH Project Officer, we are submitting this application as a Renewal, rather than a New application, providing justification for this transfer. The structure of MACC otherwise remains unchanged. Methods: MACC has a proven track record of exemplary patient accrual performance. Despite not having a site within its catchment capable of participating in the HOBIT Trial, MACC is currently tied for 5th highest enroller among 11 Hubs, enrolling 116 subjects (10.0% of total) including 35 subjects (3rd highest) in BOOST-3, 38 subjects (5th highest) in ICECAP, and 43 subjects (6th highest) in C3PO. Patient retention was 98.3% (114/116; 4th highest). This renewal application adds a strategic focus on even greater patient accrual by: 1) investing $10,000/year infrastructure funding in research coordinator support at all 6 MACC sites, 2) a Patient Accrual Liaison (PAL) to proactively identify accrual barriers, 3) rapidly resolving barriers by leveraging CTSA Collaborative Council support, 4) incorporating a Clinical Trial Practicum (entering SIREN patients) into the Clinical Trials Fellowship (CTF) to augment patient accrual, 5) adding 7 new ED expansion sites and 196,455 potential patients/year, and 6) securing an additional $1.71 Million of institutional funds for SIREN. The UCM research team, experienced in supervising Spokes, and the Center for Health and the Social Sciences, experienced in subcontract management, are strong assets. The CTF provides targeted curriculum, over 20% protected time, a Clinical Trial Practicum, K Award submission post completion, and an additional $50,000 institutional funding to train 3, 2- year fellows. All MACC sites agree to continue Reliance and Master Contract Agreements. With a Hub, 5 Spokes, 3 EMS, 4 helicopter systems, catchment of 9,931,200 people, 110,598 potential patients/year, 190 multi- disciplinary collaborators, expansion capacity of 23 adult, 5 pediatric hospitals, and 2 EMS systems, 46 research personnel, 24/7 coverage at all sites, a strategic patient accrual plan, and proven performance, MACC is well- positioned to achieve SIREN goals. Specific Aims. MACC aims to: 1) Meet/exceed recruitment goals of at least 100 subjects per year, including diverse/underserved populations, 2) Achieve all study milestones and exemplary clinical trial execution, 3) Engage a wide spectrum of investigators, 4) Mentor 3 junior faculty investigators to successful academic careers in emergency clinical trial research, 5) Contribute significantly to SIREN governance, and 6) Promote dissemination of SIREN study findings and stimulate SIREN grant applications.

中美洲 CTSA 联盟 (MACC) 提交此更新申请，以继续作为“创新紧急护理临床试验策略”(SIREN) 网络 (RFA-NS-22-015) 的区域临床中心 (RCC)。 Aufderheide（威斯康星医学院 [MCW] 中心的前联系人 PI）已宣布于 2024 年 1 月 1 日退休，因为他的在提交拨款时，替换情况未知，我们建议按照 NIH 项目的建议，将 MACC 中心从 MCW 转移到芝加哥大学医学院 (UCM)，并将联络 PI 身份转移给 David Beiser，医学博士、理学硕士 (UCM)。官员，我们将此申请作为续签申请，而不是新申请，为此次转移提供了理由。 方法：尽管没有站点，MACC 仍具有良好的患者应计绩效记录。在其内MACC 目前在 11 个中心中排名第五，招收了 116 名受试者（占总数的 10.0%），其中包括 BOOST-3 中的 35 名受试者（排名第三）、ICECAP 中的 38 名受试者（排名第五） ，43 名受试者（排名第六）的 C3PO 患者保留率为 98.3%（114/116；排名第四）。续订申请通过以下方式增加了对更大患者应计的战略重点：1) 每年投资 10,000 美元基础设施资金，用于所有 6 个 MACC 站点的研究协调员支持，2) 患者应计联络员 (PAL)，以主动识别应计障碍，3) 快速解决利用 CTSA 协作委员会的支持来克服障碍，4) 将临床试验实习（进入 SIREN 患者）纳入临床试验奖学金 (CTF)，以增强患者的能力应计，5) 每年增加 7 个新的 ED 扩展站点和 196,455 名潜在患者，以及 6) 为 SIREN 获得额外 171 万美元的机构资金，该团队在监督 Spokes 以及健康和社会科学中心方面经验丰富。在分包管理方面经验丰富，CTF 提供有针对性的课程、超过 20% 的保护时间、临床试验实习、完成后提交 K 奖以及额外的奖励。 50,000 美元的机构资金用于培训 3 名为期 2 年的研究员。 所有 MACC 站点均同意继续签订 Reliance 和主合同协议，拥有一个中心、5 个辐条、3 个 EMS、4 个直升机系统，服务对象为 9,931,200 人，每年 110,598 名潜在患者。多学科合作者，可容纳 23 名成人、5 家儿科医院和 2 个 EMS 系统的扩展能力， MACC 拥有 46 名研究人员、24/7 覆盖所有地点、战略性患者累积计划和经过验证的绩效，有能力实现 SIREN 的具体目标：1) 达到/超过至少 100 名的招募目标。每年的受试者，包括多样化/服务不足的人群，2) 实现所有研究里程碑和模范临床试验执行，3) 吸引广泛的研究人员，4) 指导 3 名初级教员研究人员紧急临床试验研究中成功的学术生涯，5) 为 SIREN 治理做出重大贡献，以及 6) 促进 SIREN 研究结果的传播并刺激 SIREN 拨款申请。