Europe’s drug agency will publish clinical trial data for new products from 2014BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e8061 (Published 26 November 2012) Cite this as: BMJ 2012;345:e8061
The European Medicines Agency has committed itself to publishing full clinical trial data submitted by companies for a clinical product once it has recommended granting marketing authorisation for that product.
The commitment will apply only to products that complete the marketing authorisation process from a set date, expected to be 1 January 2014. It will not apply to products granted marketing authorisation before this date.
This means that the agency will not have to make data available on cases of sudden death after a first dose of the multiple sclerosis drug fingolimod or safety data on two weight loss products, for which it has declined requests from researchers for access.1 2
A spokeswoman for the agency said, “The policy will be forward looking. It will apply to clinical data submitted for new medicines. For other clinical data, the current agency approach relating to reactive disclosure as part of the access to document policy remains unchanged.”
The agency has been releasing clinical trial reports on request since October 2010; and so far, it claimed, more than 1.5 million pages have been released in this way in response to safety requests. However, requests for some key data have been turned down.
The announcement that the agency would be moving to proactive disclosure of clinical data for future products was made by Guido Rasi, its executive director, at a workshop in London on 22 November convened to discuss how to improve transparency and access to clinical trial data.
He said, “The European Medicines Agency is committed to proactive publication of clinical trial data, once the marketing authorisation process has ended. We are not here to decide if we publish clinical trial data but how.”
The agency said it would establish five advisory groups involving stakeholders early next year to look in detail at protecting patients’ confidentiality; clinical trial data formats; rules of engagement; good analysis practice; and legal aspects. The groups would report in April 2013 with policy recommendations on how best to implement proactive publication.
Pressure on the agency and others to increase transparency has been mounting. The BMJ recently launched its open data campaign (bmj.com/tamiflu) with the goal of making it mandatory for researchers to publish full trial data, on the grounds that limited access to data has meant that a range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money.3
Last week the chairman of the House of Commons health select committee, Stephen Dorrell, announced that the committee would be investigating drug companies’ sharing of clinical trial data as a priority.4
Cite this as: BMJ 2012;345:e8061
For more details on the background to the European Medicines Agency’s move to proactive publication see the BMJ Group blog by Trish Groves, “A European tale—data sharing at the EMA” (http://bit.ly/Yj3NZS).