The overall goal of the Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) is to improve the outcome of patients suffering acute illness and injury by identifying effective treatments given in the earliest stages of care. Emergency conditions such as myocardial infarction, cardiac arrest, traumatic injury including brain and spinal cord injury, and seizures cause significant morbidity and mortality and exact a high cost in terms of human suffering and health care spending. Preclinical and translational research has demonstrated that there is a very narrow window of opportunity in which novel treatments for emergency conditions are optimally effective, and that conducting research in the emergency setting presents unique pragmatic challenges to clinical investigators. Effective clinical trials in these conditions require a coordinated network of emergency physicians, surgeons, cardiologists, intensivists, neurologists and biostatisticians. This proposal, in response to RFANS16014 describes the features, functions and coordination we will provide as the Clinical Coordinating Center for the SIREN network. The key elements of this structure will include an interdisciplinary team of investigators with specific expertise in the conduct of clinical trials of emergency interventions, a hub and spoke network design that acknowledges the importance of enrolling patients in the acute setting, and a long term network commitment to advancing the national research infrastructure as it relates to the interdisciplinary study of acute illness and injury. This project aims to create a coherent, collaborative, multidisciplinary emergency clinical trials community that is diverse and inclusive. The network will recruit, efficiently perform, and widely disseminate the most scientifically and clinically important trials necessary to advance the emergency care of patients with neurologic, cardiac, respiratory, hematologic and trauma emergencies. At least 4 large, simple trials in the ED and pre-hospital setting over the 5 year grant period will be initiated. The network aims to transform the emergency research enterprise, by exploring innovations in clinical trial designs (including adaptive and registry based methods), by better and earlier engagement of patient stakeholders in trial planning, and by creative improvements in implementing and performing trials.
The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) is a clinical trials network. SIREN physicians and researchers study what treatments work best for patients with emergency conditions or injuries. Emergencies may involve heart or lung conditions, problems or injuries involving the brain or spinal cord, seizures, coma, or other traumatic injuries. The SIREN will study patients in ambulances and emergency departments because many promising treatments may only work well if they are given very quickly after the onset of symptoms or injury.
