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

中美洲CTSA联盟（MACC）提交了这份续期申请，以继续作为“创新急诊护理临床试验战略”（SIREN）网络（RFA-NS-22-015）的区域临床中心（RCC）。由于Aufderheide博士（前威斯康星医学院[MCW] Hub的联系人PI）已于2024年1月1日宣布退休，并且由于在提交拨款时他的继任者未知，我们建议将MACC Hub从MCW转移到芝加哥大学医学院（UCM），并主动将联系人PI身份转移到David Beiser， MD, MS （UCM）。根据NIH项目官员的建议，我们将此申请作为续期申请提交，而不是新申请，为此次转移提供理由。MACC的结构保持不变。方法：MACC有一个良好的跟踪记录示范患者应计表现。尽管在其集水区内没有能够参加HOBIT试验的地点，MACC目前在11个中心中排名第五，共招募了116名受试者（占总数的10.0%），其中BOOST-3的35名受试者（第三高），ICECAP的38名受试者（第五高），C3PO的43名受试者（第六高）。患者保留率为98.3%（114/116，第4高）。该更新应用程序通过以下方式增加了对更大患者收益的战略关注：1)每年投入1万美元的基础设施资金，支持所有6个MACC站点的研究协调员；2)建立患者应计联系人（PAL），主动识别应计障碍；3)利用CTSA合作委员会的支持，快速解决障碍；4)将临床试验实习（纳入SIREN患者）纳入临床试验奖学金（CTF），以增加患者应计，5)增加7个新的ED扩展站点和196,455名潜在患者/年。6)为SIREN获得额外的171万美元机构资金。UCM研究团队在监督辐条方面经验丰富，健康和社会科学中心在分包合同管理方面经验丰富，是强大的资产。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50,000美元机构资金用于培训3,2年的研究员。所有MACC站点同意继续使用信实和主合同协议。MACC拥有一个枢纽、5个辐条、3个EMS、4个直升机系统、9,931,200人的服务范围、110,598名潜在患者/年、190个多学科合作伙伴、23家成人医院、5家儿科医院和2家EMS系统的扩展能力、46名研究人员、24/7全天候覆盖所有站点、战略患者累积计划和经过验证的性能，完全有能力实现SIREN的目标。具体的目标。MACC的目标是：1)达到或超过每年至少100名受试者的招聘目标，包括不同/服务不足的人群，2)实现所有研究里程碑和示范性临床试验的执行，3)吸引广泛的研究人员，4)指导3名初级教师研究人员在紧急临床试验研究中取得成功的学术生涯，5)为SIREN治理做出重大贡献，6)促进SIREN研究结果的传播并刺激SIREN资助申请。

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.