EMA expands clinical data access to researchers and public
- Transparency advocates in the EU have won a victory as the European Medicines Agency has decided to make clinical study reports (CSRs) available to the public.
- Researchers will be able to download, save and print content.
- While the EMA has reversed a previous policy of having a view-on-screen-only option, trial sponsors still retain the right to provide some of the data redacted, if it is deemed very sensitive.
The AllTrials campaign, which is comprised of a number of high-profile advocates, including the BMJ, the Cochrane Collaboration and others, is pleased with the increased level of access that the EMA is providing to researchers and the public at large. However, the issue of redacting some content is still highly contentious. Notably, the EMA has stated that the need for redaction occurs in very limited circumstances. Meanwhile, detractors also say that there are an insufficient number of CSRs available relative to the total that should be made available. The AllTrials campaign will continue to rally for additional access and the inclusion of more CSRs, with very limited redaction, but this is a huge step forward for EU researchers.