NETT NETWORKCLINICAL COORDINATING CENTER

University of Michigan

University of California San Francisco

University of Cincinnati

Introductions Bill BarsanUniversity of Michigan

4 years

NET*2

ENCTN

Introductions Dan LowensteinUniversity of California San

Francisco

2 years

ENCTN

Introductions Art PancioliUniversity of Cincinnati

2 years

ENCTN

Introductions Lewis MorgensternUniversity of Michigan

4 years

NET*2

ENCTN

Introductions Rob SilbergleitUniversity of Michigan

4 years

NET*2

Introductions Dan ClauwUniversity of Michigan

4 years

NET*2

Introductions Dave WrightEmory University

2 years

ENCTN

Introductions Vicki HertzbergEmory University

NET*2 Sites

What will make this work?

NETT

NETT

What will make this work?

Engagement of the EM community

Patients are undifferentiated

Only commonality is the ED

In-depth knowledge ED operations for all neuro-emergencies

NETT

What will make this work?

Interdisciplinary Cooperation

ED interfaces with ALL specialists

This is NOT a stroke network

We live it… in practice and in research

NETT

What will make this work?

Reaching the Community

Personal Experience

Cincinnati, East Texas, Corpus Christi, PHTSE, INSTINCT, CLEAR and more

NETT

What will make this work?

Ability to manage a multicenter ED network

Nalmefene, PHTSE, CLEAR, INSTINCT, TLL Temple, INTERACT

CACR

What will make this work?

NETT

Emergency Focus

Interdisciplinary

Community Involvement

Experienced Leadership

Updates

• Advisory Committee—Wade Smith

• Consultant—Jill Baren

• Neuro-QOL

• Eligibility Screening & Notification

• CACR updates

Advisory Comm.- Wade Smith

• Importance of neuro critical care

• Addition – Wade Smith, MD PhD – UCSF

• Chair AAN Section on Critical Care/Trauma/Emergency

• Expertise in emergent interventional trials

Consultant—Jill Baren

• Emergency exception to consent is a major issue for the network

• Jill Baren MD, MA is Peds/EM

• National expert on ethics of consent – NICHD, FDA

• PECARN study of SE using emergency exception

Neuro-QOL

• Patient reported outcome measures that traverse neurological disease entities

• Working with Dr. David Cella in development testing

• UM acting as a test site for derivation/validation for Roadmap grant

Screening & Notification

• Jim Quinn – Stanford

• Test rollout of realtime screening and notification system (KDH)

• Ongoing – using this system at UM

Center for the Advancement of Clinical Research (CACR)

• UM has applied for CTSA

• $10 million for clinical research informatics

• Part of NIH NECTAR network

• Dan Clauw is the PI of both CTSA and the Roadmap grant

QUESTIONS?

Emergency Exception

• These regulations can improve the quality of research done in this network

• NETT can help the FDA, NIH, and OHRP ensure the quality of the regulations

• Build on experience, consensus, and innovation

Emergency Exception

Experience• UCSF-PHTSE – approved by 9 IRB• UC – experience with emergency exception

Consensus Efforts• May 2005 Consensus Conference• Explicit Regulatory Intent• Resuscitation Outcome Consortium

Emergency Exception

Innovation

• Proposal for a Specialized Central IRB

• Alternatives mechanisms when possible

• Build on NIH funded work on the subject

RAMPART Datalogger

Providing data loggers, stepper controllers, data acquisition and custom engineering services to customers worldwide

RAMPART Datalogger

RMV Quote

A. PROJECT SCOPE

HARDWARE:Deferential GPS Interface with embedded antenna.Lithium Battery with battery autonomous battery charger.8 Analog Input Channels, w signal conditioning, for further sensors.Temperature sensor embedded.Voice digitizing/recording real time circuits, embedded microphone.USB interface for downloading data, or setting logger functions.Multimedia Flash EPROM interface for off-line data transfer.Compensated Real Time Clock.Water Resistance Enclosure. Temperature range -15˚ C to + 50˚ C.Input Signals for reading switches (opening the a paramedics box). Hardware necessary for firmware upgrade in the field. Printed Circuit Board (PCB).

FIRMWARE:Charge Battery SoftwareLogging FunctionsFile System Compatibility Storing Data.Power Management.USB Media File System.Voice compression and voice recordingGPS Parser Functions Memory Management and Errors Checking algorithms

B. PROTOTYPE COMPLETION DATE RMV Electronics Inc. will make its best effort to deliver the prototype data logger by no latter than 10 to 12 weeks, from the starting time. 

C. DEVELOPMENT COST  RMV Electronics Inc. will charge for developing a Data Logger with the above technical specification the amount in US dollars : US$ 31,750.00 This price depends on the final requirements. An approximately Data Logger Cost in quantities of 500 to 100 Units is as follows: US$490.00 to US$720.00   D. TERMS and CONDITIONS  Please note that upon agreement with the University of Michigan to engage the services of RMV Electronics Inc. to undertake this project, a deposit of 50% of the total contract amount is required.  The total amount of the contract should be paid to RMV Electronics Inc, when the completed software is received  

NETT and SPOTRIAS

• NETT is a large academic and community network addressing all neuro-emergencies

• SPOTRIAS is a small network of highly specialized stroke centers

• In stroke research, SPOTRIAS is an incubator and NETT is a real world test environment

NETT and ROC

• NETT is a large academic and community network addressing all neuro-emergencies

• ROC is a small network of high volume academic centers concentrating on cardiac arrest and hemorrhagic shock

• ROC has not demonstrated any interest in neurologic outcomes or TBI

NETT and CRC

• NETT is a large academic and community network addressing all neuro-emergencies

• CRC is an office-based initiative to improve the study of chronic neurological disease

• There is no overlap in the trials CRC and NETT would run, but there may be some synergies

Incentives – Hubs

• Infrastructure Funding

• Publications

• Participation in Network Leadership

• Training and Education

Incentives - Spokes

• Academic-Community Partnerships– Marketing– Continuing Medical Education Credits– Supports Certification Efforts

Incentives - Investigators

• Brings trial access to translational researchers

• Quicker easier startup / enrollment• Large network• Access to special cutting edge resources• Preservation of intellectual leadership• Preservation of academic credit

Industry Sponsored Trials

• Considered because we want the studies that will best advance the public health, no matter where they come from

• Nonprofit fiscal structure to be developed with and accountable to the NINDS

• Margins re-invested in the network infrastructure

Building EMS partnership

• Successful models– PHTSE– FAST Mag

• Work with NAEMSP– Researchers– Leadership

Imaging

• No requirement for imaging in RFA

• But… likely to be needed in future

• Multiple options are being explored– CACR experience (Collaborative PET Imaging

Trial - 7R01AG022394-03)– Chelsea Kidwell (SPOTRIAS Imaging Core

development - intramural)

Clinical Translation

• “Translation-conscious” trial designs

• Phase IV surveillance

• Foundational data sets

• Investigations into clinical translation

RAMPART Power Curve

Non inferiority, obs. Δ = 5%, α = 0.05

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CLEAR enrollmentBased on "SPOTRIAS Timeline" with CLEAR enrollment overlay in grant submission