The document summarizes the European Translational Research Information and Knowledge Management Service (eTRIKS) project. It describes how eTRIKS created an open-source translational data platform based on tranSMART to enable data sharing across studies. Over 30 months, eTRIKS supported over 60 projects, developing best practices for data harmonization, legal agreements, and sustainability. However, fully meeting project goals proved challenging, and the pharmaceutical industry undercommitted resources. Moving forward, eTRIKS assets will be distributed to academic partners to ensure ongoing sustainability.

1. European Translational Research Information and Knowledge Management Service
http://www.etriks.org p.agapow@imperial.ac.uk, jay.m.bergeron@pfizer.com
eTRIKS: Successes, Surprises and Lessons on the Verge of
Completing the Largest General Translational Informatics
Public Private Partnership to Date
Pharmaceutical IT Congress, London September 2017

2. Enable translational research by:
• Common open source platform
• Multi-study data harmonisation
• Developing best practices
• Providing support for translational research projects
• Sustainability

3. Program Goals

4. Open Source
Translational Data Warehouse
q Developed by J&J (Janssen)
q Based on I2B2
q Cloud Hosted (Amazon EC2)
q Open Source
q Management of Clinical/Molecular
Data
q Repository, User Interface, ETL
Tools

5. Integrated and explorable data are valuable data! www.etriks.org
Application to Platform
Cohort Creation
Hypothesis
Analysis/Export

6. Integrated and explorable data are valuable data! www.etriks.org
Curation Services
• Grounded by the Standards Starter
Pack
• Combination of modification for
consistency and harmonization to
established standards
• Implemented using the “ICE” tool
and/or ad hoc scripting
Application to Platform

7. Integrated and explorable data are valuable data! www.etriks.org
eTRIKS Research
Application to Platform
eTRIKS Labs
eTRIKS Operations
eTRIKS Harmonization Service (eHS)
eTRIKS Analytical Environment EAE
SmartR
Supplemental Tools Branded as the
eTRIKS Labs

8. Integrated and explorable data are valuable data! www.etriks.org
HiDome
Similarity Network Fusion
Integrated Visualizations
Application to Platform
eTRIKS Labs
Disease Networks/Maps

9. Integrated and explorable data are valuable data! www.etriks.org
Application to Platform
eTRIKS Labs

10. What We Have Done, What We Do
In less than 30 months eTRIKS has created an open access information platform
and accompanying services to bolster collaborative engagements by speeding
and democratizing access to translational research results
“Knowledge Management in U-BIOPRED without eTRIKS would have been like running a clinical
trial without GCP.”
Professor Peter Sterk of the University of Amsterdam
“eTRIKS provides gel without which we would be floating in pool of excess data with no direction.”
Professor Ian Adcock of Imperial College London
PostgreSQL

11. Integrated and explorable data are valuable data! www.etriks.org
At Project Mid Point
Deliveries
Compute Infrastructure
• Established, two projects hosted
Base Open Platform
• Created/Integrated/Released
Applicable Standards
• Assessed and Codified
Curation
• Services applied to multiple projects
Sustainability
• eTRIKS Network proposal
Engagement
• 13 Projects supported
Ethics/Security
• Guidelines for reuse of patient data
Challenges
• Support for 40 projects unlikely
• Legal issues impeding/preventing
• Hosting strategy
• Federation
• Multi-tenancy
• Project desires preventing
• Multi-tenancy
• Provision of integrated data sets
• EFPIA partner under-commitment
• Reorganization
• Loss of key personnel
• Lack of adoption of the platform
• MTAs/CDAs
• Extremely problematic to close
• Academic publications

12. Integrated and explorable data are valuable data! www.etriks.org
Outreach
Patients and Projects
0
20
40
60
80
100
120
0 20 40 60 80 100 120
Days since document sent
% eTRIKS Signatures outstanding for ABIRISK
agreement
ABI-RISK (Materials Transfer MTA)
Oncotrack (Data Processing DPA)

13. Integrated and explorable data are valuable data! www.etriks.org
Confidential Disclosure Agreements
• Created an “Mandate”
• Allowed the Coordinator (AZ) to
sign CDAs on behalf of the
collaboration given GA approval
Materials Transfer Agreements
• Created a general template
Data Processing Agreements
Outreach
Patients and Projects
Guidance for Project/Project Interaction
Use agreements that only cover those organisations that are directly involved in the joint activities.
Ensure that new grant and project agreements include a mandated CDA
• when possible, an MTA template for data processing is agreed as part of the project agreement

14. Integrated and explorable data are valuable data! www.etriks.org
Outreach
Patients and Projects
41 Rules consistent with the Eu Directive
The Directive “on the protection of individuals
with regard to the processing of personal data
and on the free movement of such data”
(95/46/EC, 24 October 1995)
The General Data Protection Regulation
REGULATION (EU) 2016/679 “on the protection of natural persons with regard to the
processing of personal data and on the free movement of such data
• A single set of harmonized rules binding for all EU member states
• Replace the directive, increased personal protection
• Came into force on 24th May 2016, will be law as of 25th May 2018

15. Willingness to share data
Results of a public survey – 2.000 people in the UK
35% Did not trust the NHS with
their data
56% Would not allow their data
to be shared
22% Personal data had been shared
without their consent
Integrated and explorable data are valuable data! www.etriks.org

16. Integrated and explorable data are valuable data! www.etriks.org
Outreach
Patients and Projects
Value of data sharing and reuse
Discussion
game
Finding
convergence
Concrete actionSmall groups
Interviews
Canvas

17. Integrated and explorable data are valuable data! www.etriks.org
Outreach
Patients and Projects
• A Strategy
– Enable bilateral engagements across projects
• Contract templates
• Best practices to facilitate working engagements
– Enable productive interactions with data owners
• Understand personal data policies and guidelines
• Build trust with data providers, researchers and
patients through ethical behavior and legal constructs
– Enable productive interactions with the public
• Raise awareness to the healthcare benefits of data
reuse

18. Integrated and explorable data are valuable data! www.etriks.org
Best Practices

19. Integrated and explorable data are valuable data! www.etriks.org
Comprehensive Engagements (6)
End Collaboration Prep (2) Multi-Study Programs (16) Specialty Development (2)
OPTIMISE
Enabling Engagements: Platform, Consulting, Training, Catalog (32)
RA-MAP
PREPARE
RASP
Tech 4
Strat Meds
60 Supported Projects
CF-MAP
Athero-MAP
Anaphylaxis-MAP
PD-MAPLCDM
ACIM
ACSN
MS-MAP
And
Counting
Chart
Target

20. Integrated and explorable data are valuable data! www.etriks.org
RA MAP
eHS
eTRIKS
v1
eTRIKS
v2
eTRIKS v3
eTRIKS v4
eTRIKS v5
CDAs MTAs
Public Server
Best Practices

21. Integrated and explorable data are valuable data! www.etriks.org
Sustainability
Assets Distributed to the Individual Academic Partners
Imperial College London (Y. Guo)
• eTRIKS Platform elements to Imperial College, (with noted exceptions)
• eHS, EAE and platform elements associated with eTRIKSv5
• eTRIKS Website
U of Luxembourg (R. Schneider)
• Public Server and project data residing on eTRIKS infrastructure
• SmartR, Data Catalog
• Service Portal
European Institute for Systems Biology and Medicine
• Disease Networks/Maps
Biosci Consulting
• Patient Input Plan
U of Oxford (S. Sansone)
• Standards Starter Pack

22. Integrated and explorable data are valuable data! www.etriks.org
Sustainability
Commercial Spin Off from the U of Luxembourg
• Offering curation, disease map and other services
Program Management
• Large Scale PPP services: contracting, consulting, business
development, collaboration
Commercial
Sustainability
Model
Training Material and
Patient Input Plan
considered project IP
Platform elements
open licensed under
GPLv3 or Apache 2

23. Integrated and explorable data are valuable data! www.etriks.org
Synopsis
Meeting the Target KPI - priceless
Meeting All Deliverables
Favorable Academic Outcomes
Commercial Sustainability Plan
But Pharma direct benefits slim
(substantially underspent)
Is the PPP the right model for
information technology projects?
Enhancements difficult to apply
broadly, integration is hard
There’s standards & standards
tranSMART needs refactoring &
repurposing
Curation still arduous

24. Integrated and explorable data are valuable data! www.etriks.org

25. Integrated and explorable data are valuable data! www.etriks.org
Backup

26. Initial Clients
Unbiased biomarkers for the prediction
of respiratory disease outcomes
Anti-Biopharmaceutical Immunization: prediction
and analysis of clinical relevance to minimize the RISK
Methods for systematic next generation oncology
biomarker development

27. eTRIKS PLATFORM
Founded on tranSMART
GPL v3 Open Source Translational Data Warehouse
Building upon Janssen’s Award Winning Translational Informatics System
Demonstrated Success with the U-BIOPRED IMI Project