Neurological Emergencies Treatment Trial Network Statistical/Data Management Ctr

点击翻译按钮获取中文摘要

DESCRIPTION (provided by applicant): The overall goal of the Neurological Emergencies Treatment Trials (NETT) Network is to improve the outcomes of patients with acute neurological illness and injury by identifying effective treatments given in the earliest stages of care. In developing the NETT, the NINDS recognized that pre-clinical and translational research has demonstrated that there is a very narrow window of opportunity in which novel treatments for neurological emergencies are optimally effective, and that conducting research in the emergency setting presents unique pragmatic challenges to clinical investigators. Over the past four years, the NETT has proven to be a platform capable of selecting, developing, and simultaneously conducting multiple confirmatory clinical trials of very early interventions delivered in the ambulance or the emergency department (ED). The NETT has successfully competed for funding and implemented four actively enrolling clinical trials, two of which utilize exception from informed consent (EFIC), and one of which is already nearing completion. Several other trials are being developed with investigators from within as well as outside of the NETT. In all the trials initiated in NETT, subject accrual has been ahead of expectations and on budget. The successful operation can be attributed to the efficiency of the NETT organization and processes. The coordinating activities of the NETT is supported by two NINDS cooperative agreement grants to the Clinical Coordinating Center (CCC) at the University of Michigan (U01 NS056975) and the Statistical and Data Management Center (SDMC) in the Division of Biostatistics and Epidemiology (DBE) at the Medical University of South Carolina (U01 NS059041). In addition, 17 academic centers (Hubs) participate in the NETT with R01 grant support to each center from the NINDS. For the second five-year grant period, the SDMC's aims are to maintain the collaborative relationship with all parties involved in the NETT and to continue to provide efficient data management support and statistical expertise for clinical trials to be conducted by the NETT. We will also explore innovations in clinical trial designs including adaptive Study designs. PUBLIC HEALTH RELEVANCE: Ambulances and EDs are difficult venues in which to perform clinical trials, but it is in the earliest phases of care that neuroprotective and other critical interventions are most likely to be effective. The NETT is tasked with performing in these venues confirmatory trials with readily applicable results that can immediately impact patient care. The NETT has proven its capabilities to carry out this work, and its continued effort is paramount to efficiently and simultaneously implement these important multicenter trials.