After years of debate and a late controversy, the European Medicines Agency (EMA) has adopted a clinical trial transparency policy that will come into force on January 1. And unlike a recent draft of the policy, the final version allows researchers to download the data.
The draft published in May only allowed users to view data on their computer screens. Downloading, saving, editing, photographing, printing, distributing or transferring of the information were all banned, limitations that would have made it difficult--if not impossible--to analyze the data to reach conclusions about the safety or efficacy of a drug.
"That restriction would have stopped the reviews and computation of multiple studies that are necessary to work out which medicines have the best and worst effects," Tracey Brown, managing director of British charity Sense About Science, said in a statement. Researchers, transparency advocates and the European ombudsman all welcomed the decision to drop the restriction.
EMA referred to resistance to the data limitations from these groups and individuals in its explanation of what has changed since the May draft. The critics all welcomed the change, but have concerns about several other areas of the EMA policy, notably the decision to give pharma companies the right to propose redactions to their clinical study reports (CSRs).
"It is still the case that trial sponsors might be able to cut out any information they don't want others to see," Brown said. EMA has the final say on whether a redaction is needed and has already said it thinks most CSRs contain no commercially confidential information.
- read FierceBiotech's take
- check out AllTrial's release
- here's the ombudsman's response
- and the EMA consultation review (PDF)