Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network Clinical Center (Hub)

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The ability to effectively study and develop innovative treatments for acute critically ill or injured patients has been challenging. Many of these devastating conditions occur infrequently ,which lessens the ability to enroll large number of patients into clinical trials. Many render the patient incapacitated, and identification of their legally authorized representatives to provide meaningful prospective informed consent for participation may not be possible. Yet, the current therapies for many of these devastating conditions are often understudied or unsatisfactory. With these issues in mind and because of the sincere desire to improve acute care of critically ill and injured patients, the Strategies to Innovate Emergency Care Clinical Trials network ( SIREN ) has been created. This proposal is for the establishment of a SIREN Hub at the Department of Emergency Medicine at the University of Minnesota (UMn SIREN). The University of Minnesota is uniquely qualified to serve as the SIREN Hub , with academic depth in various domains of acute critical care, pre-hospital and emergency research. The Hub leadership is experienced in the spectrum of acute care clinical research, pre-hospital research, the use of Exception from Informed Consent for acute critical care clinical trials. The various specialties needed to collaborate for successful implementation of SIREN are aligned with collaborative arrangements beyond traditional departments. The Specific Aims of Year One are; 1. Create the UMn SIREN hub infrastructure using lessons learned from the Minnesota NETT Hub and UMn Stroke Net Regional Coordinating Center. 2. Prepare and support Spokes and aligned Emergency Medical Service ( EMS) agencies for the launching of SIREN clinical trials. 3. Determine best methods of monitoring Spoke performance and develop quality assurance processes to ensure compliance with all regulatory requirements for the conduct of clinical trials. 4. Recruit , engage and maintain involvement of pre-hospital, emergency and acute care clinicians; Spoke leadership and institutions; and health care systems and EMS in SIREN activities and SIREN clinical trials.