Data Transparency with the EMA
Data transparency has been a fast-evolving field since 2013 when the EMA sent out the first draft of Policy 0070 for public review and the EFPIA published the Principles for Responsible Clinical Trial Data Sharing. EMA Policy 0070 Phase 1, focusing on CSRs, has been effective since 1 January 2015 and about 100 Policy 0070 submissions were processed and published before it paused in August 2018 due to Brexit and the resulting EMA business continuity plan.
Health Canada’s equivalent policy has recently been finalised, and effective since 1 April 2019, while the FDA has been conducting pilots with industry to further define their approach to publications of CSRs (still not effective). None of the regulators have yet implemented policies around sharing of Individual Patient Data (IPD), but a number of initiatives (CSDR, Yoda, Project Data Sphere, etc.) have been active for five years or more to support secondary-purpose analyses using IPD based on research requests.
This session will feature a presentation on current efforts from regulators and other organisations to enable data sharing, and a presentation from the EMA on the status of Policy 0070, followed by a Q&A and panel discussion.
– Anne-Sophie Henry-Heude, EMA
– Jean-Marc Ferran, Qualiance