Mid-America CTSA Consortium (MACC) as a Regional Clinical Center for the Strategies to Innovate EmeRgENcy Care Clinical Trials (SIREN) Network

威斯康星医学院的监督中心(SH)与2 参加所有SIREN试验的发言人(紧急医疗服务[EMS]和急诊科[ED])- 帕克兰纪念医院(PMH)在德克萨斯大学西南医学中心发表讲话 卫理公会医院演讲(MH)，印第安纳大学和3个芝加哥Spokes参加一个或多个ED SIREN试验(西北纪念医院演讲[NMH]，芝加哥大学医学中心演讲 [UCMC]和伊利诺伊大学医院[UIH])正在将此申请提交给 成为“创新急诊临床试验战略”(SIREN)的区域性临床中心 网络将被称为中美洲CTSA联盟(MACC)。MACC将由联系人Pi协调， Tom Aufderheide，医学博士，MS方法：MACC已经被战略性地组装起来，以高效和最大限度地 支持警笛患者的收益。妇幼保健会参与了两个复苏结果联盟 (ROC)和神经急症治疗试验(NETT)网络(5,007名受试者)。PMH一直是一家 中华民国第一名(7,300科)。MH已经让3309名受试者参加了NIH的独立试验。芝加哥3强 代言人带来了更大的ED患者收益，获得了特定疾病的机会，以及相当大的、服务不足的人口。 MACC由一个枢纽和5个Spokes、3个EMS和3个直升机系统组成。集水区为9931,200 人，97,265个潜在的警报器研究对象/年，长期的多学科合作，以及 扩建基地可容纳16家成人医院和5家儿科医院，1个急救系统和1个直升机系统，MACC拥有 显著增加患者收入的基础设施以及支持任何警报器的固有灵活性 学习。我们利用共有41名研究人员的常备基础设施，24/7全天候覆盖 (MCW SH、PMH、NMH、UIH)或计划中的(UCMC、MH)。MCW SH研究团队，经验丰富 监督10个NETT Spokes，是一项强大的资产。所有MACC站点也同意主合同协议 作为集中的IRB审查。承诺追加133万美元的机构资金补充 PI/Co-I努力并确保了诱人的目标。临床试验将由MACC CTSA协作组提供支持 委员会和反恐委员会创伤网络咨询委员会。中国的国家领导力和科学专长 反腐败委员会的调查员将提供专业的临床领导，促进全国警报器意识，以及 独立的警报器拨款申请。具体目标：MACC的目标是：1)利用我们的基础设施和 达到或超过每年至少100名受试者的招聘经验，包括多样化和服务不足的受试者 人口，2)协调MACC以达到或超过所有警报器确定的里程碑，3)参与 具有心脏病学、神经病学、创伤外科、血液学、肺病学和其他专业知识的调查人员，4) 利用反腐败委员会的科学专门知识为治理委员会作出重大贡献，以及5)利用反腐败委员会 领导职位，以传播SIREN研究结果，并刺激独立SIREN拨款申请。

The Supervising Hub (SH) at the Medical College of Wisconsin (MCW) in collaboration with 2 Spokes participating in all SIREN trials (emergency medical services [EMS] and emergency department [ED]) - Parkland Memorial Hospital Spoke (PMH) at the University of Texas Southwestern Medical Center and Methodist Hospital Spoke (MH), Indiana University, and 3 Chicago Spokes participating in one or more ED SIREN trials (Northwestern Memorial Hospital Spoke [NMH], University of Chicago Medical Center Spoke [UCMC], and the University of Illinois Hospital Spoke [UIH]) are submitting this application for consideration to become a Regional Clinical Center for the “Strategies to Innovate EmeRgENcy Care Clinical Trials” (SIREN) Network to be known as the Mid-America CTSA Consortium (MACC). MACC will be coordinated by Contact PI, Tom Aufderheide, MD, MS. Methods: MACC has been strategically assembled to efficiently and maximally support SIREN patient accrual. The MCW SH has participated in both the Resuscitation Outcomes Consortium (ROC) and Neurological Emergencies Treatment Trials (NETT) networks (5,007 subjects). PMH has been a top enroller in ROC (7,300 subjects). MH has entered 3,309 subjects in independent NIH trials. The 3 Chicago Spokes bring larger ED patient accrual, access to specific diseases, and a sizable, underserved population. MACC consists of a Hub and 5 Spokes, 3 EMS and 3 helicopter systems. With a catchment of 9,931,200 people, 97,265 potential SIREN study subjects/year, long-standing multi-disciplinary collaboration, and expansion site capacity of 16 adult and 5 pediatric hospitals, 1 EMS, and 1 helicopter system, MACC has the infrastructure to significantly contribute to patient accrual and the inherent flexibility to support any SIREN study. We capitalize on the standing infrastructure of 41 total research personnel, with 24/7 coverage in place (MCW SH, PMH, NMH, UIH) or planned (UCMC, MH) at all sites. The MCW SH research team, experienced supervising 10 NETT Spokes, is a strong asset. All MACC sites agree to Master Contract Agreements as well as Centralized IRB Review. Commitment of an additional $1.33 million of institutional funding supplements PI/Co-I effort and secures SIREN goals. Clinical trials will be supported by the MACC CTSA Collaborative Council, and the MACC Trauma Network Advisory Board. The national leadership and scientific expertise of the MACC investigators will provide expert clinical leadership, promotion of national SIREN awareness, and independent SIREN grant applications. Specific Aims: MACC aims to: 1) Leverage our infrastructure and experience to meet or exceed recruitment of at least 100 subjects per year, including diverse and underserved populations, 2) Orchestrate MACC to meet or exceed all SIREN-determined milestones, 3) Engage investigators with expertise in cardiology, neurology, trauma surgery, hematology, pulmonology, and others, 4) Exploit MACC scientific expertise to significantly contribute to governance committees, and 5) Utilize MACC leadership positions to disseminate SIREN study findings and stimulate independent SIREN grant applications.