Download - Slide Set - NETT Overview (general use)
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Neurological EmergencyTreatment Trials Network
Overview of the new network
nett.umich.edu
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Overview
1. The Problem - Neurological Emergencies
2. Developing a Solution
3. The Nuts and Bolts - NETT
4. Impact
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1. Neurological Emergencies
• Spectrum of pathology
• High burden of disease
• Importance of early treatment
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• Neurotrauma: Brain & Spinal Cord Injury
• Stroke: Ischemic & Hemorrhagic
• Status Epilepticus
• CNS Infections: Meningitis & Encephalitis
• Anoxic Brain Injury
• Others: Bell’s Palsy, Headache, etc.
Neurological EmergenciesSpectrum of Pathology
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Neurological EmergenciesHigh Burden of Disease
Acute Ischemic Stroke
200 per 100,000 people
Mortality 17% at 30 days
1st Yr cost $91,000 /patient
Kissela B et al. Stroke 2004;35(2):426-31.
Klijn CJ et al. Lancet Neurol 2003;2(11):698-701.
Taylor TN, Drugs 1997;54 Suppl 3:51-7
Williams GR et al, Stroke 1999;30(12):2523-8
Intracerebral hematoma
15 per 100,000 people
Mortality 50% at 30 days
1st Yr cost $124,000 /patient
Taylor TN, Drugs 1997;54 Suppl 3:51-7
Broderick JP, et al. J Neurosurg 1993;78(2):188-91
Qureshi AI et al. N Engl J Med 2001;344(19):1450-60
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Neurological EmergenciesHigh Burden of Disease
Traumatic Brain Injury
100 per 100,000 people
Mortality 29% at 30 days
1st Yr cost $136,000 /patient
NIH Consensus Panel, JAMA 1999;282(10):974-83.
Brown AW, et al. NeuroRehabilitation 2004;19(1):37-43.
CDC Fact Sheet: Traumatic Brain Injury (NCIPC), 2005
Spinal Cord Injury
4 per 100,000 people
Mortality 20% at 30 days
1st Yr cost $200,000 /patient
Sekhon LH, et al. Spine 2001;26(24 Suppl):S2-12.
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Neurological EmergenciesHigh Burden of Disease
Status Epilepticus
40 per 100,000 people
Mortality 22% at 30 days
1st Yr cost $40,000 /patient
Bassin S, et al. Crit Care 2002;6(2):137-42
Claassen J, et al. Neurology 2002;58(1):139-42
DeLorenzo RJ, et al. Neurology 1996;46(4):1029-35
Penberthy LT, et al. Seizure 2005;14(1):46-51
Wu YW, et al. Neurology 2002;58(7):1070-6
Subarachnoid Hemorrhage
6 per 100,000 people
Mortality 50% at 30 days
1st Yr cost $228,000 /patient
Taylor TN, Drugs 1997;54 Suppl 3:51-7
Broderick JP, et al. J Neurosurg 1993;78(2):188-91
Schievink WI. N Engl J Med 1997;336(1):28-40
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Importance of Early TreatmentLessons Learned
National Acute Spinal Cord Injury Study (NASCIS) Methylprednisolone
I (1979-84) – enrolled up to 48 hours, negative
II (1984-90) – enrolled up to 12 hours, negative….….but positive in subset treated <8 hours
III (1990-97) – enrolled up to 12 hours, negative
Bracken MB, et al. JAMA 1984;251:45-52, Bracken MB, et al. N Engl J Med 1990;322:1405-11Bracken MB, et al. JAMA 1997;277:1597-604
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Importance of Early TreatmentLessons Learned
Thrombolytics in Acute Ischemic Stroket-PA and streptokinase
ECASS (I-II) up to 6 hours, mean 4:24 negative
MAST (I+E) up to 6 hours, mean 4:36 negative
NINDS up to 3 hours, mean 1:59 positive
NINDS Stroke Study Group. N Engl J Med. 1995; 333:1581–7MAST-E Study Group. N Engl J Med. 1996; 335:145–50, MAST-I Group. Lancet. 1995; 346:1509–14
Hacke W, et al. JAMA. 1995; 274:1017–25, Hacke W, et al. Lancet. 1998; 352:1245–51
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2. Developing a solution
• Boots on the ground
• Multi-disciplinary composition
• Emergence of a network
• Design for the future
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Boots on the groundEmergency Medicine driven
• Neurological emergencies are treated in the initial minutes and hours after arrival mainly by emergency physicians.
• The ED is a challenging and chaotic environment in which to conduct research.
• Emergency physicians represent the “boots on the ground”, those on the front line with the manpower and expertise to conduct research in the ED.
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Multi-disciplinary compositionNeurology, Neurosurgery, EMS, Neuro Critical Care, and Trauma
• Research encompassing a continuum of care that starts in the ambulance or in the emergency department and continues in the ICU, in the OR, on the stroke unit, or in the clinic.
• Network leadership, Hub PI’s, and Trial PI’s represent a range of specialties.
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Multi-disciplinary collaborationsWorkforce by Specialty in the US
• 12,000 adult neurologists*
• 1,500 pediatric neurologists
• 3,500 neurosurgeons
• 4,000 hospital emergency departments
• 22,000 emergency physicians
*30% in solo private practice
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Emergence of a network
Oct 2003 First organizational NET*2 meeting
Mar 2004 NIH conference on ENTCN
2004-2005 NET*2 planning/pilot grant applications
Nov 2005 RFA for NETT Coordinating Center
Apr 2006 RFA for NETT Hubs and SDMC
Aug 2006 NETT Coordinating Center awarded
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Design for the futureLarge simple trial designs
•Streamlined protocols
•Collect only essential data (short case report forms)
•High enrollment – lower per-patient costs
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Design for the futureEmphasis on intervention
•Focus on phase III intervention trials
•Patient-oriented readily-applicable results
•Diverse enrollment (patients & practice environments)
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Design for the futureConsent issues
•Exception to informed consent for emergency research
•Optimize methods that respect human subjects
•Dedicate network resources to facilitate local efforts
•Help develop centralized IRB review
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3. Nuts and Bolts
• What – the mission and vision
• Who – the participants
• Why – the incentives
• How – the organizational structure
• When – the time line
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Mission
The mission of the Neurological Emergencies Treatment Trials (NETT) Network is to improve outcomes of patients with acute neurological problems through innovative research focused on the emergent phase of patient care.
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Vision
NETT will engage clinicians and providers at the front lines of emergency care to conduct large, simple multi-center clinical trials to answer research questions of clinical importance. The NETT structure will be utilized to achieve economies of scale enabling cost effective, high quality research.
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NETT Coordinating and Hub Sites
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• Investigators Initiated Studies– Incentives and Limitations– Application Process
• Industry Sponsored Studies– Network / Investigator Design
Study SelectionInvestigator Initiated Studies
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Study SelectionInvestigator Initiated Studies
• Incentives– Investigator receives the trial award– Scientific control, credit, authorship preserved– Infrastructure already established
• Limitations– Fewer funds stay at investigators institution– Commitment to stay within the network
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Study SelectionInvestigator Initiated Studies
• Process
– NETT Trial Guidelines
– Clinical Trial Subcommittee & NETT-AG
– Administrative Consultation
– Submission for Scientific Review
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Study SelectionIndustry Sponsored Studies
• Network / Investigator Design
– Scientific Control
– Shared Economies of Scale
– No Direct Subsidy
– NETT-AG solicits scientific review
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Hub and Spoke design
Spoke
Spoke
CCCHubSpoke
17 Hubs
Approximately 41-70 Spokes
Hence a total of up to 80+ enrolling sites
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SDMC
DSMB
NETT-AG NINDS
ScientificProgramDirector
Site Mgmt Operations
Trial MgmtLeadership
Hubs
TrialPI
CCC
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Timeline
• Several simultaneous trials
• Staggered planning / enrollment
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How much does it cost? Grant support of NETT
TotalDirectTotalDirect
$25.5M Direct $38.3M Total over 5 years
$30.6M$20.4M$7.7M$5.1MTotal
$20.4M$13.6M$5.1M$3.4MAll 17
$1.2M$800K$300K$200KHubs U10
$3M$2M$750M$500KSDMC U01
$6M$4M$1.5M$1MCCC U01
FY 2007-10FY 2006
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4. Impact
• Opportunity to advance care of patients with neuro-emergencies
• Large NIH investment in emergency medicine clinical research
• Re-engineering the clinical research enterprise
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nett.umich.edu
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Priming the pipeline
• RAMPART
• INTERACT
• ProTECT
• NABPS
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Rapid Anticonvulsant MedicationPrior to Arrival Trial (RAMPART)
• Paramedic treatment of status epilepticus• Standard treatment is IV benzodiazepine• IV starts difficult / dangerous in the convulsing patient• Best IV agent, lorazepam, impractical for EMS• IM treatment is faster and easier• Best IM agent, midazolam, is practical for EMS
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Rapid Anticonvulsant MedicationPrior to Arrival Trial (RAMPART)
• IM midazolam autoinjector v. IV lorazepam• Double dummy blinded design• Exception to consent for emergency research• Outcome: termination of seizure prior to ED arrival• Sample 800 patients (400 per group)• Intention to treat, non-inferiority analysis
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US-Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT-US)
• Hematoma expansion is associated with worse outcomes in patients with ICH
• Very early elevated BP may contribute to acute hematoma expansion
• Acute hypertension is common with ICH• Optimal BP targets in patients with ICH are unknown
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US-Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT-US)
• Compare systolic target of 140 vs. 180 mmHg• US modification of study originally designed in
Austraila by our current collaborators• Phase II Trial, feasibility / safety primary outcomes• Sample 400 patients (200 per arm)
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Hub pre-RFA slides
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What does an application need?
• We don’t really know
• Enrollment• Experience• Collaboration
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Enrollment
• Sufficient patient volume• Access to diverse diagnoses
– Adults and children– Neurotrauma, TBI and SCI– Stroke, ischemic and hemorrhagic– Seizure, meningitis, anoxic injury
• Local infrastructure
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Experience
• ED clinical trials (any disease)• Institutional track record• Cross disciplinary research
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Collaboration
• Emergency Medical Services• Spokes
– Diversity– Buy in
• Cross disciplinary– Emergency Medicine– Neuro-Critical Care– Neurology / Neurosurgery– Trauma surgery
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Spokes
• Don’t have to use all spokes for all trials• Look for areas of concentration
– Trauma– Stroke– EMS expertise
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Budget suggestions
• Include all effort needed to:– Set up the program– Prepare potentially complex IRB apps– Enroll subjects in two trials, best guess– Collect and report data– Provide informatics support
• Include– Travel to investigator meetings
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Resources
• RFA for the 3 components• ENCTN final report• UM CCC application
• Links to all available athttp://sitemaker.umich.edu/NETT
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Simple Version
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What is NETT?
Neurological Emergencies Treatment TrialsA new clinical trials network dedicated to:
– Cross-disciplinary cooperation
– Interventions in minutes not hours
– Large simple trial streamlined trial designs
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How will NETT work?
• Hub and Spoke Design– Large– Scalable
• Public Utility Model– Open– Economical
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What kinds of questions?
Does very early intensive blood pressure lowering prevent hematoma expansion and improve outcome in patients with ICH?
The INTERACT trial
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What kinds of questions?
Does a lower dose of thrombolytic plus a glycoprotein inhibitor improve efficacy and reduce bleeding complications compared to standard dose thrombolysis?
The CLEAR trial
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What kinds of questions?
Can progesterone infusion improve survival and neurological outcome in patients with traumatic brain injury?
The ProTECT trial
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What kinds of questions?
Can IM midazolam stop seizures as effectively as IV lorazepam in the prehospital care of status epilepticus?
The RAMPART trial
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What kinds of questions?
Whatever question you want to ask…
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What’s the impact?
• Opportunity to advance care of patients with neuro-emergencies
• Large NIH investment in emergency medicine clinical research
• Re-engineering the clinical research enterprise
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How will you be involved?
• As a Practitioner
• As a Hub co-investigator
• As a Trial investigator
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Alternate Slides
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NETT Impact
• High level of enthusiasm by the academic emergency medicine community for high-quality, non-pharma driven clinical research.
• High public visibility of treatment-oriented clinical research.
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NETT Benefits and Risks
• Immediate invigoration of neurologic community
• Broader involvement of trainees in research
• Large number of trials in the pipeline
• NETT will lead to efficient research in many diseases
• Tight budget• Small numbers of Hubs• Scientific review
committee tough and less interested in practical trials
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Special Challenges to studyingNeurological Emergencies
• Urgency: recruitment in minutes not hours
• Multiple disciplinary involvement: EMS, emergency medicine, neurology, pediatrics, neurosurgery, radiology, traumatology, rehabilitation, others
• Conditions complicate informed consent
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Defining Principals
• Very early enrollment• Diverse enrollment, hub and spoke design• Large simple trials
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Operational Principals
• Streamlined operations• Technological efficiencies when possible• Centralized outcome assessments• Clinical translation
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Neurological EmergencyTreatment Trials Network
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Burden of Neurological Emergencies
*Per patient in first year, **Rehabilitation only
$50**807.5Anoxic brain injury
$402240Status epilepticus
$8121.5Bacterial meningitis
$200204Spinal cord injury
$13629100Traumatic brain injury
$228506Subarachnoid hemorrhage
$1245015Intracerebral hemorrhage
$9117200Acute Ischemic Stroke
%Cost* thousands $
Mortality 30-day
Incidence per 100,000
Disorder
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