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

中美洲 CTSA 联盟 (MACC) 作为创新紧急护理临床试验 (SIREN) 网络战略的区域临床中心

• 批准号: 10197231
• 负责人: TOM Paul AUFDERHEIDE
• 金额: $ 14.17万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10197231
• 关键词: Accident and Emergency department; Adult; Agreement; American College of Surgeons; Americas; Anesthesia procedures; Applications Grants; Awareness; Cardiac; Cardiology; Caring; Chicago; Clinical; Clinical Trials; Clinical and Translational Science Awards; Collaborations; Contracts; Disease; Emergency Care; Emergency Department patient; Emergency Situation; Emergency medical service; Funding; Goals; Heart Arrest; Helicopter; Hematology; Hospitals; Illinois; Indiana; Informed Consent; Infrastructure; Institutional Review Boards; Interdisciplinary Study; Intervention; Lead; Leadership; Life; Location; Medical center; Methodist Church; Methods; Neurological emergencies; Neurology; Operative Surgical Procedures; Outcome; Patients; Pediatric Hospitals; Performance; Population Heterogeneity; Positioning Attribute; Principal Investigator; Pulmonary Embolism; Pulmonology; Quality of life; Research; Research Design; Research Personnel; Resuscitation; Secure; Site; Study Subject; Supervision; Surgeon; System; Testing; Texas; Time; Trauma; Underserved Population; United States National Institutes of Health; Universities; Wisconsin; base; clinical care; clinical center; experience; flexibility; improved; innovation; medical schools; neurosurgery; recruit; trauma surgery; treatment trial

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.

威斯康星州医学院（MCW）的监督枢纽（SH）与2合作 参加所有警笛试验（EMS]和急诊室[ED]）的发言人 - 德克萨斯大学西南医学中心的帕克兰纪念医院（PMH）和 卫理公会医院讲话（MH），印第安纳大学和3个芝加哥参与一个或多个ED 警笛试验（西北纪念医院[NMH]，芝加哥大学医学中心讲话 [UCMC]和伊利诺伊大学医院的讲话[UIH]）正在将此申请提交给 成为“创新急诊临床试验策略”的区域临床中心（Siren） 网络被称为中美洲CTSA联盟（MACC）。 MACC将通过联系PI协调 医学博士Tom Aufderheide，MS。方法：MACC已战略性地组装以有效，最大程度地组装 支持警笛患者的负责。 MCW SH都参加了两个复苏结果联盟 （ROC）和神经系统紧急治疗试验（NETT）网络（5,007个受试者）。 PMH一直是 ROC的最高招募者（7,300名受试者）。 MH已在独立的NIH试验中输入3,309名受试者。 3芝加哥 辐条带来了更大的ED患者准确性，获得特定疾病的机会以及大量服务的人群。 MACC由一个枢纽和5个辐条，3个EMS和3架直升机系统组成。流域为9,931,200 人，97,265个潜在的警笛研究主题/年，长期的多学科合作和 MACC的16名成人和5家儿科医院，1家EMS和1架直升机系统的扩展现场容量 基础架构可显着有助于患者的准确性和继承灵活性以支持任何警报器 学习。我们利用41名研究人员的常设基础设施，并进行了24/7的覆盖范围 （MCW SH，PMH，NMH，UIH）或计划（UCMC，MH）在所有站点。 MCW SH研究团队，经验丰富 监督10个净辐条是一项强大的资产。所有MACC网站都同意掌握合同协议 作为集中的IRB评论。额外的133万美元的机构资金补充剂承诺 PI/CO-I努力并确保警笛目标。临床试验将由MACC CTSA协作支持 理事会和MACC创伤网络顾问委员会。国家领导和科学专业知识 MACC调查人员将提供专家临床领导，促进国家警笛意识以及 独立的警笛赠款申请。具体目的：MACC的目的是：1）利用我们的基础设施和 每年至少满足或超过100名受试者的经验，包括潜水员和服务不足 人群，2）协调MACC以满足或超过所有警笛确定的里程碑，3）参与 具有心脏病学，神经病学，创伤手术，血液学，肺病学等专业知识的研究者，4） 利用MACC科学专业知识为治理委员会做出了重大贡献，5）使用MACC 传播警报研究结果并刺激独立警报赠款的应用程序的领导职位。