NETT NETWORK CLINICAL COORDINATING CENTER

1. NETT NETWORKCLINICAL COORDINATING CENTER University of Michigan University of California San Francisco University of Cincinnati

2. Introductions Bill Barsan University of Michigan 4 years NET*2 ENCTN

3. Introductions Dan Lowenstein University of California San Francisco 2 years ENCTN

4. Introductions Art Pancioli University of Cincinnati 2 years ENCTN

5. Introductions Lewis Morgenstern University of Michigan 4 years NET*2 ENCTN

6. Introductions Rob Silbergleit University of Michigan 4 years NET*2

7. Introductions Dan Clauw University of Michigan 4 years NET*2

8. Introductions Dave Wright Emory University 2 years ENCTN

9. Introductions Vicki Hertzberg Emory University

10. NET*2 Sites

11. What will make this work? NETT

12. 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

13. What will make this work? NETT Interdisciplinary Cooperation ED interfaces with ALL specialists This is NOT a stroke network We live it… in practice and in research

14. What will make this work? NETT Reaching the Community Personal Experience Cincinnati, East Texas, Corpus Christi, PHTSE, INSTINCT, CLEAR and more

15. What will make this work? NETT Ability to manage a multicenter ED network Nalmefene, PHTSE, CLEAR, INSTINCT, TLL Temple, INTERACT CACR

16. What will make this work? Emergency Focus Community Involvement NETT Interdisciplinary Experienced Leadership

17. Updates • Advisory Committee—Wade Smith • Consultant—Jill Baren • Neuro-QOL • Eligibility Screening & Notification • CACR updates

18. 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

19. 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

20. 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

21. Screening & Notification • Jim Quinn – Stanford • Test rollout of realtime screening and notification system (KDH) • Ongoing – using this system at UM

22. 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

23. QUESTIONS?

24. 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

25. 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

26. Emergency Exception Innovation • Proposal for a Specialized Central IRB • Alternatives mechanisms when possible • Build on NIH funded work on the subject

27. Providing data loggers, stepper controllers, data acquisition and custom engineering services to customers worldwide RAMPART Datalogger

28. 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 Software Logging Functions File System Compatibility Storing Data. Power Management. USB Media File System. Voice compression and voice recording GPS 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   RAMPART Datalogger

29. 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

30. 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

31. 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

32. Incentives – Hubs • Infrastructure Funding • Publications • Participation in Network Leadership • Training and Education

33. Incentives - Spokes • Academic-Community Partnerships • Marketing • Continuing Medical Education Credits • Supports Certification Efforts

34. 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

35. 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

36. Building EMS partnership • Successful models • PHTSE • FAST Mag • Work with NAEMSP • Researchers • Leadership

37. 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)

38. Clinical Translation • “Translation-conscious” trial designs • Phase IV surveillance • Foundational data sets • Investigations into clinical translation

39. RAMPART Power Curve Non inferiority, obs. Δ = 5%, α = 0.05

40. CLEAR enrollment Based on "SPOTRIAS Timeline" with CLEAR enrollment overlay in grant submission