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

中美洲CTSA联盟（MACC）提交了此续期申请，以继续作为“EmeRgENcy Care临床试验创新策略”（SIREN）网络的区域临床中心（RCC）（RFA-NS-22-015）。由于Aufderheide博士（威斯康星州医学院[MCW] Hub的前联系PI）已宣布于2024年1月1日退休，并且由于在提交资助时他的继任者未知，因此我们建议将MACC Hub从MCW转移到芝加哥医学大学（UCM），并主动将联系PI状态转移到大卫贝瑟，MD，MS（UCM）。根据NIH项目官员的建议，我们将此申请作为更新申请而不是新申请提交，以提供此次转移的理由。反腐败委员会的其他结构保持不变。方法：MACC在示范性患者应计绩效方面有着良好的记录。尽管在其覆盖范围内没有能够参与HOBIT试验的研究中心，但MACC目前在11个中心中并列第5高入组者，入组了116例受试者（占总数的10.0%），包括BOOST-3中的35例受试者（第3高）、ICECAP中的38例受试者（第5高）和C3 PO中的43例受试者（第6高）。患者保留率为98.3%（114/116;第4高）。此续订申请通过以下方式增加了对更大患者累积的战略关注：1）每年投资10，000美元的基础设施资金，用于支持所有6个MACC站点的研究协调员，2）患者应计联络员（PAL），以主动识别应计障碍，3）通过利用CTSA协作理事会支持快速解决障碍，4）纳入临床试验实践（进入SIREN患者）加入临床试验研究基金会（CTF），以增加患者招募，5）增加7个新的艾德扩展中心和196，455名潜在患者/年，以及6）为SIREN获得额外的171万美元的机构资金。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健康管理方面经验丰富，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，K奖提交完成后，以及额外的50，000美元的机构资金来培训3，2年的研究员。所有MACC地点同意继续实施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，9，931，200人的覆盖范围，110，598名潜在患者/年，190名多学科合作者，23家成人医院，5家儿科医院和2个EMS系统的扩展能力，46名研究人员，24/7覆盖所有站点，战略患者累积计划和经过验证的性能，MACC有能力实现SIREN的目标。具体目标。反贪会的目标是：1）达到/超过每年至少100名受试者的招募目标，包括多样化/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执行，3）吸引广泛的研究者，4）指导3名初级教师研究者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研究成果的传播，鼓励SIREN基金的申请。

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.