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ADAPT
Australia
CIHR - IRCS
India
CENTER-TBI
InTBIR
Towards Global Collaborations
Andrew MaasDavid Menon
May 28, 2015Arlington, USA
ONE MIND
TRACK-TBI
China
WHAT IS INTBIR?InTBIR : International Initiative for TBI ResearchCollaboration : European commission – NIH/NINDS – CIHR
INTBIR IS MORE THAN THE SUM OF ITS PARTS The logic of common data platforms (CDEs)
The opportunities provided by Rx variations (CER)
The public benefit of open access to curated data A global research team with unlimited
resources
The strength of numbers Making impossible questions answerable New research paradigms (incremental
phenotype) Data driven approaches (INCF)
The power of networks Accelerating knowledge transfer to patient care A paradigm shift in research collaborations
INTBIR PROJECTS
Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial
CREACTIVE study on TBI
CIHR studies
Neuroinform
atics and biostatistics platform
e-CRF
QuesgenMike
Jarrett
INCFSean Hill
CENTER-TBI COLLABORATION
44 scientific institutes
76 sites for data collection
22 countries
Ego = 1
Knowledge
‘More the knowledgelesser the ego, lesser the knowledgemore the ego …’
- Albert Einstein
MAKING COLLABORATIONS WORK
TEAM = TEAM
Make everyone feel responsible Facilitate (sub)studies
Con
Increased burden of data collection
DATA SHARING: TENSIONS
Data sharing ↔ current system of academic credits
Funding agencies Strong pressure to grant early access to other investigators Motivation : accelerate TBI research; optimal use of public funding
Investigators“protectionistic” attitude Motivation : safeguard own work and credits
Data sharing = collaboration
PARADIGM SHIFTSThe past : Clinical trials: isolate out 1 single factor for treatment Protectionistic approaches
The present : Broader generalizable approaches Sharing and collaboration
PARADIGM SHIFTS ARE ONLY SUSTAINABLE IF…
Culture changes System of academic credits changes
EXAMPLES OF HOW PROTECTIONISM INHIBITS PROGRESS
The IMPACT projectInternational Mission for Prognosis and Analysis of Clinical Trials in TBI
NIH funded 2003-2013 > 60 publications
Prognosis : Robust prognostic models Trial design and analysis : Increase power by 50% Common Data Elements : Standardization
‘this letter serves as IMPACT’s demand that Antwerp and/or Erasmus immediately cease and desist from any and all use of the IMPACT Word Mark and the ImPACT mark or any other designations confusingly similar thereto in connection with neurocognitive evaluation products or related goods or services…’
ATTACK ON IMPACT
EXAMPLE OF PROTECTIONISM INHIBITS PROGRESS ‘OWNERSHIP OF OUTCOME INSTRUMENTS’
Two of the proposed outcome instruments licensed by Pearson inc. BSI and WAIS-IV subtests.
Problem: Require translation and linguistic validation into multiple languages.
Company demands Pay license fee Provide all translations to company Transfer all intellectual property rights on translations to company
NO GO
CHALLENGES IN A MULTINATIONAL PROJECT
12Selection based upon Common Data Elements recommendations from Wilde et al. Arch. Phys. Med. Rehabil. 91.11 (2010): 1650-1660, expert discussion, comparability with TRACK-TBI
Outcomes for CENTER-TBI.Translations of outcome instruments
CHALLENGES IN A MULTINATIONAL PROJECT
STANDARDIZATION OF MR IMAGES
• 3 vendors : GE, Philips, Siemens• Per vendor multiple scanner types• Per vendor/scanner combination multiple software
versions• Software versions are not backwards compatible (even
within sub-version e.g. protocol from 4.5.6 can’t be used on 4.5.5.) • Outdated software (licenses are very expensive)• Software licenses -> license for DTI, fMRI, BOLD
sometimes not present (expensive)• Coils -> 8, 12, 20, 32, 64 channels
31 sites, 31 different set-ups!
CHALLENGES IN A MULTINATIONAL PROJECT
STANDARDIZATION OF MR IMAGES
Example: Siemens• Scanner types: 3• Software versions: 6• Coil types: 4 • Number of channels: 5 different
3x6x4x5 = 360 possibilities (actually this is not true, because a scanner has a limited number of configurations)
12 scanners, only 2 with the same configuration
CHALLENGES IN A MULTINATIONAL PROJECT
STANDARDIZATION OF MR IMAGES
• 3T only• coils
• “black box” implementations of MRI sequences• available staff (MR physicist, MR Tech,
neuroradiologist)
• software versions• time & willingness to test
• COMMUNICATION
RECRUITMENT STATUS CENTER-TBI
Essential components of CENTER-TBI
17
Provider profiling : finger print of center characteristics, in terms of organization, structure, protocol, process.
Standardized data collection.
Complete outcome assessments.
CENTER-TBI : AN INTEGRAL PICTURE
Neuroinform
atics and biostatistics platform
e-CRF
QuesgenMike
Jarrett
INCFSean Hill
THE POTENTIAL OF IMPROVED CHARACTERIZATION
National Research Council (US) Committee on A Framework for Developing a New Taxonomy of Disease. Toward Precision Medicine. Washington (DC): National Academies Press (US); 2011.
Provider profilingCharacterising systems and delivery of care in centres
Unadjusted for case mix Adjusted for case mix
IMPACT database (n=9578) 2.4 3.3
IMPACT – US (n=3325) 2.0 2.4
IMPACT – EU (n=5706) 2.4 3.8
A NEW VISION : MAKE USE OF THE EXISTING HETEROGENEITY
• Do not limit heterogeneity
• Comparative Effectiveness
• Multilevel: structure – process – individual
To include the “why” question
CENTER-TBI Registry n=15-25 000
CENTER-TBI Core Study (n=5400)
CENTER-TBI Europe78 sites
Recruitment : 18 monthsAim : 5400 patients
Current enrollment Core Data : 300 Registry : 700
Center-TBI China40 sites
Ready to start
coordinators : Professor Jiang
Dr Gao
Increased output and enhanced efficiency by
International collaboration
Data sharing
Global franchising
NIH
InTBIR
EU
CIHR
China India
Australia New-Zealand
THE CHANGING LANDSCAPE OF TBI RESEARCH
• Broad and generalisable approaches• Comparative effectiveness research • Collaboration and data sharing• Global efforts
WHAT WILL GLOBAL COLLABORATION FURTHER GIVE
• Unique network of collaboration
• Huge knowledge resource
• Make our world smaller – safer – and a better place
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