FITBIR: A Platform for International Collaboration June, 2013

1. FITBIR:A Platform for International CollaborationJune, 2013 Ramona Hicks, PhD Program Director, National Institute of Neurological Disorders and Stroke (NINDS)

2. Federal Interagency TBI Research (FITBIR) Informatics System – What’s in it for you?

3. But coming soon

4. Federal Interagency TBI Research (FITBIR) Informatics System – What’s in it for us?

5. 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) TBI is a Major Public Health Problem

6. 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 FITBIR: What’s in it for all of us?

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. 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. FITBIR aims to: • Facilitate meta-analysis • Enable new analyses • Link seemingly disparate • research severity time age

10. How? • Standardization • Technological infrastructure and support • Governance and policies to ensure high quality data and reasonableaccess • Collaborative research community

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. Where can the TBI common data elements be found? • Websites • Publications • APMR, Nov 2010 • Pediatric modifications, J Neurotrauma, April 2012 • Version 2.0, J Neurotrauma, June 2013

13. Technological infrastructure and support

14. FITBIR Governance

15. Quarterly uploads of baseline data Outcomes data is available on a rolling basis after study completion or earlier by request if approved Data Sharing Policy Quality Control 0 – 6 months Approved FITBIR Users 12 months + FITBIR Data Submitters 6 – 12 months Study Team 6– 12 months

16. Collaborative research community Towards an International Initiative for Traumatic Brain Injury Research – Brussels, October 2011

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. 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. FITBIR Vision- A knowledge network to accelerate research and inform TBI clinical practice

20. FITBIR - A Platform for International Collaboration Low hanging fruit or reaching for the stars?