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

有效研究和开发急性危重病或受伤的创新治疗方法的能力 病人们一直在挑战。许多这种破坏性的情况很少发生， 降低了将大量患者纳入临床试验的能力。许多人认为病人 无行为能力，并确定其合法授权代表，以提供有意义的 参与的前瞻性知情同意可能是不可能的。然而，目前的治疗方法 许多这些破坏性的条件往往没有得到充分的研究或不能令人满意。这些问题 铭记并因为真诚的愿望，以改善急性护理危重病和受伤 创新急救护理临床试验网络（SIREN） 创造该提案旨在紧急事务部建立警报中心 明尼苏达大学医学院（UMn SIREN）。明尼苏达大学是唯一 有资格担任SIREN中心，在各个领域的学术深度急性关键 护理、院前和紧急情况研究。中心领导层在以下领域经验丰富： 急诊临床研究，院前研究，知情同意例外的使用 用于急性重症监护临床试验合作成功所需的各种专业 SIREN实施与超越传统的合作安排相一致 部门 第一年的具体目标是： 1.利用明尼苏达州NETT的经验教训创建UMn SIREN中心基础设施 HUB和UMN中风网络区域协调中心。 2.准备和支持辐条和对齐的紧急医疗服务（EMS）机构， 启动SIREN临床试验。 3.确定监控轮辐性能的最佳方法并制定质量保证 确保符合临床试验实施的所有监管要求的流程。 4.招募、参与并维持院前、急诊和急症护理人员的参与 临床医生;发言领导和机构;以及SIREN中的医疗保健系统和EMS 活动和SIREN临床试验。

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.