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.
This research provides a network of locations capable of implementing research designed to test promising interventions to improve survival and quality of life for people with life threatening emergencies. Establishing this research network should produce quicker results than would otherwise be possible, reducing the time it takes to improve clinical care.
