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 are 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 CCC's aims are to maintain and enhance the collaborative relationships that form the NETT, develop trials that address important clinical questions, effectively disseminate and translate our findings, and continue to provide efficient project management 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

The Neurological Emergencies Treatment Trials (NETT) is a clinical trials network. NETT physicians and researchers study what treatments work best in patients with stroke, brain or spinal cord injury, seizures, coma, or other neurological emergencies. The NETT studies 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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01NS056975-09
Application #
8731277
Study Section
Special Emphasis Panel (ZNS1-SRB-R (51))
Program Officer
Janis, Scott
Project Start
2006-08-20
Project End
2016-05-31
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
9
Fiscal Year
2014
Total Cost
$2,179,483
Indirect Cost
$684,388
Name
University of Michigan Ann Arbor
Department
Emergency Medicine
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Guetterman, Timothy C; Fetters, Michael D; Mawocha, Samkeliso et al. (2017) The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adap SAGE Open Med 5:2050312117736228
Haggins, Adrianne N; Harney, Deneil; Scott, Sara et al. (2017) A systematic review of Federal Drug Administration Docket for community consultation and public disclosure in exception from informed consent trials. Clin Trials :1740774517737318
Mawocha, Samkeliso C; Fetters, Michael D; Legocki, Laurie J et al. (2017) A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network. Clin Trials 14:246-254
Meurer, William J; Legocki, Laurie; Mawocha, Samkeliso et al. (2016) Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project. Trials 17:373
Martin, Renee' H; Yeatts, Sharon D; Hill, Michael D et al. (2016) ALIAS (Albumin in Acute Ischemic Stroke) Trials: Analysis of the Combined Data From Parts 1 and 2. Stroke 47:2355-9
Callaghan, Brian C; Kerber, Kevin A; Banerjee, Mousumi et al. (2016) The evaluation of distal symmetric polyneuropathy: utilisation and expenditures by community neurologists. J Neurol Neurosurg Psychiatry 87:113-4
Qureshi, Adnan I; Palesch, Yuko Y; Barsan, William G et al. (2016) Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med 375:1033-43
Betjemann, John P; Lowenstein, Daniel H (2015) Status epilepticus in adults. Lancet Neurol 14:615-24
Legocki, Laurie J; Meurer, William J; Frederiksen, Shirley et al. (2015) Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis. BMC Med Ethics 16:27
Ginsberg, Myron D; Hill, Michael D (2015) Symptomatic intracranial hemorrhage in the ALIAS Multicenter Trial: relationship to endovascular thrombolytic therapy. Int J Stroke 10:494-500

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