Researcher access reinstated, but company redaction rights may cause issues
The European Medicines Agency (EMA) has finalised its policy for sharing data from clinical trials. After wrangling between companies and research campaigners, the regulator has settled on a policy that grants independent researchers access to download and use data from trials, but retains companies’ abilities to restrict certain information.
The EMA will automatically make all Clinical Study Reports for trials relating to approved drugs available online. Members of the public will be allowed to read the reports, and verified researchers will be allowed to download and analyse the data – a key sticking point in previous versions of the policy, which limited researchers to on-screen viewing.
However, companies will retain the ability to redact certain information within the reports, if the EMA agrees that that information could be classed as commercially sensitive. Campaign groups such as AllTrials, while welcoming the policy overall, point out that this could still prevent researchers from accessing the information they need to make informed decisions on the quality of trial results.