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

有效研究和开发治疗急性危重病或受伤的创新治疗方法的能力 病人们一直很有挑战性。许多这样的破坏性情况很少发生，这 降低了招募大量患者参加临床试验的能力。许多人将患者 无行为能力，并确定其合法授权的代表，以提供有意义的 参与的预期知情同意可能是不可能的。然而，目前的治疗方法 许多这种毁灭性的情况往往没有得到充分的研究或令人不满意。在这些问题上 铭记并出于改善危重病人和伤员急救的真诚愿望 患者，创新急诊临床试验网络的战略(SIREN) 已创建。这项提议是为了在紧急情况部建立一个警报中心。 明尼苏达大学医学院(UMN SIREN)。明尼苏达大学是唯一 有资格担任警报器中心，在急性危急事件的各个领域具有学术深度 护理、院前和急诊研究。Hub领导层在以下领域拥有丰富的经验 急性护理临床研究、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。成功协作所需的各种专业知识 实施SEREN符合传统以外的协作安排 各部门。 第一年的具体目标是； 1.使用从明尼苏达州NETT吸取的经验教训创建UMN警报器枢纽基础设施 枢纽和UMN卒中网区域协调中心。 2.准备和支持SPOKS和联合紧急医疗服务(EMS)机构 启动SIREN临床试验。 3.确定监测辐条性能的最佳方法，并制定质量保证 确保符合进行临床试验的所有法规要求的流程。 4.招募、聘用和维持院前、急救和急救的参与 临床医生；直言不讳的领导和机构；以及警报器中的卫生保健系统和EMS 活动和警报器临床试验。

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.