research & innovation international rare disease consortium: data sharing policy 3 rd...
TRANSCRIPT
Research & Innovation
International Rare Disease Consortium: Data Sharing Policy
3rd International Traumatic Brain Injury Research Meeting
Catherine BERENSHead of Sector Neuroscience
Medical research and the challenge of ageing UnitDG Research & Innovation
European Commission
Research & Innovation
Goals of IRDiRC
200 new therapies for rare diseases by 2020
Means to diagnose most rare diseases by 2020
2
Images courtesy of FreeDigitalPhotos.net
Research & Innovation
3
Basic principlesof IRDiRC
• Co-operation at international level to stimulate, better coordinate & maximise output of rare disease research efforts around the world
• Teams up public and private organisations investing in rare diseases research
• Research funders with relevant programmes >$10 million US over a 5-year period can join & work together
• Each organisation funds research its own way
• Funded projects adhere to a common framework
Research & Innovation
− 1 representative per funding body or group of funders
− Representatives of umbrella organisations of patient advocacy groups
− Chairs of the Scientific Committees
Around 15 top-level experts with balanced representation of scientists, patients, industry, etc.
Representatives of funded projects
Executive Committee
Interdisciplinary Therapeutics Diagnostics
Scientific Committees
Working Groups
Ethics &governance
Biobanks
Registries & natural history
Bio-informatics
and data
sharing
Biomarkers
Small molecules
Repurposing
Bio-technology
Regulatory
Ontologies Sequencing
Model
systems
Genome/
phenome
Research & Innovation
Policies• Collaborative research: sharing resources, data
and results among IRDiRC research projects; avoiding duplication; making publicly available
• Involve patients (or representatives) in all relevant research aspects
• International, national, regional and local legislation/regulation to be adhered to (data protection; ethics approvals)
Generalized principles
Research & Innovation
Guidelines• Consider impact of research on patients as key:
best ethical practices to ensure interest of individuals
• Disseminate and make available information about IRDiRC and IRDiRC projects
• Education, training and awareness of stakeholders to be encouraged by IRDiRC
Generalized principles
Research & Innovation
Policies• Research projects should adhere to standards
endorsed by IRDiRC
• Data producers acknowledge their responsibilities to (i) release data rapidly and (ii) publish initial analyses in a timely manner. IRDiRC members will encourage and facilitate rapid data release.
Data sharing & standards
Guidelines• Data generated from research projects , incl.
source data, to be deposited in appropriate open or controlled-access public databases
Research & Innovation
Clinical Trials Regulation
• Responds to criticism of previous EU Clinical Trials Directive:
• Single submission portal for multinational trials
• Joint assessment by Member states' competent authorities
• Tacit-approval deadlines
• Reduced administrative burden (low-risk trials)• Adopted on 16 April 2014• Applicable as from 6 months after the EU portal and
database are functional (not earlier than May 2016)
EU legislation revision (I)
Research & Innovation
Personal Data Protectionlegislative framework
• Proposal of the European Commission: 25 January 2012:• update and modernise the principles enshrined in the 1995
Data Protection Directive (digital age) • build on the high level of data protection in place in Europe
• Positive vote of European Parliament: 12 March 2014• Awaiting position of Council• Moving from a Directive to a Regulation:
one continent = one law, with effective sanctions• Level-playing field: operate on EU market = stick to EU
law• Right to be forgotten• Simplification: "one-stop-shop"
EU legislation revision (II)
Research & Innovation
How does this link to InTBIR?
• IRDiRC policies and guidelines are broad
• Could be adapted to be fit for purpose
• Important aspects of
• Collaborative research
• Involvement of patients/representatives
• Respect legislation
Conclusions
