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.
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.
|Dickert, Neal W; Govindarajan, Prasanthi; Harney, Deneil et al. (2014) Community consultation for prehospital research: experiences of study coordinators and principal investigators. Prehosp Emerg Care 18:274-81|
|Zhao, Wenle; Durkalski, Valerie (2014) Managing competing demands in the implementation of response-adaptive randomization in a large multicenter phase III acute stroke trial. Stat Med 33:4043-52|
|Zhao, Wenle (2014) A better alternative to stratified permuted block design for subject randomization in clinical trials. Stat Med 33:5239-48|
|Bruno, Askiel; Durkalski, Valerie L; Hall, Christiana E et al. (2014) The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial protocol: a randomized, blinded, efficacy trial of standard vs. intensive hyperglycemia management in acute stroke. Int J Stroke 9:246-51|
|Elm, Jordan J; Palesch, Yuko; Easton, J Donald et al. (2014) Screen failure data in clinical trials: Are screening logs worth it? Clin Trials 11:467-472|
|McMullan, Jason T; Jones, Elizabeth; Barnhart, Bruce et al. (2014) Degradation of benzodiazepines after 120 days of EMS deployment. Prehosp Emerg Care 18:368-74|
|McMullan, Jason T; Pinnawin, Ashley; Jones, Elizabeth et al. (2013) The 60-day temperature-dependent degradation of midazolam and Lorazepam in the prehospital environment. Prehosp Emerg Care 17:1-7|
|Dickert, Neal W; Mah, Victoria A; Baren, Jill M et al. (2013) Enrollment in research under exception from informed consent: the Patients' Experiences in Emergency Research (PEER) study. Resuscitation 84:1416-21|
|Connor, Jason T; Elm, Jordan J; Broglio, Kristine R et al. (2013) Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus. J Clin Epidemiol 66:S130-7|
|Silbergleit, Robert; Lowenstein, Daniel; Durkalski, Valerie et al. (2013) Lessons from the RAMPART study--and which is the best route of administration of benzodiazepines in status epilepticus. Epilepsia 54 Suppl 6:74-7|
Showing the most recent 10 out of 17 publications