1. Neurological Emergencies Treatment Trials SAEM 2006

2. Disclaimer We don’t have authoritative answers to any of your questions We have applied to be the Clinical Coor- dinating Center for this application, but this has not been awarded to anybody yet We do not represent the NINDS or any agency here, we are just sharing personal opinions based on having thought a lot about this network

3. History Oct 2003 - first organizational NET*2 meeting Mar 2004 – NIH conference on ENTCN 2004-2005 NET*2 investigator initiated planning and pilot trial grant applications / surveillance Nov 2005 – RFA for NETT Coordinating Center Apr 2006 – RFA for NETT Hubs and SDMC

4. Defining Principals Set forth by NINDS Very early enrollment Diverse enrollment, hub and spoke design Large simple trials

5. Operational Principals Our vision Streamlined operations Technological efficiencies when possible Centralized outcome assessments Clinical translation

6. Impact Opportunity to advance care of patients with neuro-emergencies Large NIH investment in emergency medicine clinical research Re-engineering the clinical research enterprise

7. What does an application need? We don’t really know Enrollment Experience Collaboration

8. 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

9. Experience ED clinical trials (any disease) Institutional track record Cross disciplinary research

10. Collaboration Emergency Medical Services Spokes –Diversity –Buy in Cross disciplinary –Emergency Medicine –Neuro-Critical Care –Neurology / Neurosurgery –Trauma surgery

11. Spokes Don’t have to use all spokes for all trials Look for areas of concentration –Trauma –Stroke –EMS expertise

12. 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

13. Budget suggestions

14. Resources RFA for the 3 components ENCTN final report UM CCC application Links to all available at http://sitemaker.umich.edu/NETT