1. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FITBIR: A Platform for International Collaboration June, 2013 Ramona Hicks, PhD Program Director, National Institute of Neurological Disorders and Stroke (NINDS)

2. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 2 Federal Interagency TBI Research (FITBIR) Informatics System – What’s in it for you?

3. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 3 But coming soon

4. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 4 Federal Interagency TBI Research (FITBIR) Informatics System – What’s in it for us?

5. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 5 TBI is a Major Public Health Problem Complex problem because of variable ages, severities, causes and types of injuries, and outcomes Diagnostic and prognostic tools are insufficient Lots of treatments, but of the 229 recommendations contained in seven TBI Guidelines publications, only four are based on class I evidence (Maas et al., 2011) RCTs aren’t succeeding - At least 20 compounds and therapeutic interventions have been subjected to more than 50 phase 2 and 3 clinical trials in the last three decades – none demonstrated effectiveness (Tolias & Bullock 2006)

6. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 6 FITBIR: What’s in it for all of us?  Rich data test beds for: Tool and biomarker development Comparative effectiveness research Development of novel therapies  Consolidation of resources Currently > 600 TBI studies posted on clinicaltrials.gov TBI research is distributed across multiple agencies  Collaboration and team science  Scientific rigor and efficiency  Better patient outcomes

7. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 7 Where did FITBIR come from? TBI Classification Workshop 2007 IMPACT ADNI NDAR NIDRR TBI Model Systems International CDE Project for TBI TRACK - TBI

8. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 8 What is FITBIR? U.S. Department of Defense and NIH collaboration launched in 2011 TBI Research Informatics System  Searchable, shareable clinical research database  Electronic data collection tools  Operational support  Policies and oversight  Analytical tools (in the future)

9. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 9 FITBIR aims to: severity age time Facilitate meta-analysis Enable new analyses Link seemingly disparate research

10. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 10 How? Standardization Technological infrastructure and support Governance and policies to ensure high quality data and reasonable access Collaborative research community

11. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 11 Standardization International TBI CDE Project  > 200 participants, March 2009  Pediatric modifications – March 2010 Version 2.0 - July 2012 Organization:  Core  Epidemiology  Acute, hospital  Rehabilitation and out-patient  Concussion and mild TBI

12. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 12  Websites  Publications APMR, Nov 2010 Pediatric modifications, J Neurotrauma, April 2012 Version 2.0, J Neurotrauma, June 2013 Where can the TBI common data elements be found?

13. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 13 Technological infrastructure and support

14. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 14 FITBIR Governance Governing Committee Executive Committee Strategic Vision Committee Common Data Elements Steering Committee Design & Development Team Operations Team Policy Committee Data Access and Quality Committee

15. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 15 Data Sharing Policy Quarterly uploads of baseline data Outcomes data is available on a rolling basis after study completion or earlier by request if approved Quality Control 0 – 6 months Study Team 6– 12 months FITBIR Data Submitters 6 – 12 months Approved FITBIR Users 12 months +

16. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 16 Collaborative research community Towards an International Initiative for Traumatic Brain Injury Research – Brussels, October 2011

17. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 17 Collaborative research opportunities NIH Research Initiatives  InTBIR  CTE: Neuropathology and Neuroimaging  Pilot projects on sports-related concussion  Legacy data (under development) DOD/VA Chronic Effects of Neurotrauma Consortium National Intrepid Center of Excellence (NiCOE) Investigator-initiated projects – 18 studies will begin uploading data in the coming year

18. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 18 FITBIR – What’s next? Focus on high priority research questions - Data output just as important as data input Evaluate and re-evaluate for value and productivity - Build what users want and need Support demonstration projects Align with other databases and projects Expand to include preclinical data

19. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 19 FITBIR Vision- A knowledge network to accelerate research and inform TBI clinical practice

20. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 20 Low hanging fruit or reaching for the stars? FITBIR - A Platform for International Collaboration