Abstract
The European Medicines Agency, which has released documents in response to about 75% of 455 requests made to it over the past 2 years, is committed to proactive publication of clinical trial data by 2014.
Europe's drug regulator, the European Medicines Agency (EMA), has released more than 1.6 million pages of regulatory documents, including clinical study reports, since it made a change to its transparency policy in 2010. Of 455 requests over the past 2 years, approximately 75% resulted in the release of documents, according to an article appearing in JAMA Archives of Internal Medicine.
The EMA plans more policy changes to increase transparency in the coming year. “The Agency is committed to its policy on proactive publication of clinical trial data by 2014,” says Hans-Georg Eichler, MD, senior medical officer at the EMA.
This approach contrasts with that of the U.S. Food and Drug Administration (FDA). The FDA discloses data after a request under the U.S. Freedom of Information Act, but it protects commercial trial data as confidential, unlike the EMA.
“We take it as self-evident that the same standard of openness should apply to all trial data, whether sponsored by industry, investigator initiated, or sponsored by public grant-giving bodies,” wrote Eichler in an April 2012 PLoS Medicine perspective on the subject, which he says remains an up-to-date outline of the EMA's commitment to transparency. The EMA considers clinical trial data to include the protocols, data analyses, and figures as well as the raw data generated by the trial.
“A 10-page journal article could be a summary of a 10,000-page clinical study,” says Tom Jefferson, PhD, an independent epidemiologist for the Cochrane Collaboration who used EMA data in a review of Genetech's Tamiflu. If those data are secret, patients and other researchers don't get any benefit from the study beyond the potential drug approval, he says.
This is particularly important in oncology, adds Jefferson, where “there's a huge amount of unpublished data.”
As the capabilities of scientific computing advance, the potential to use these massive datasets for medical benefit is increasing. “There are only a few users of this data now,” says Jefferson. “But in 10 years' time, there will be many.”
The EMA held a transparency workshop in November 2012 to obtain a variety of perspectives on data transparency. One key concern about releasing raw trial data involves balancing the need to maintain patient confidentiality with the intent of patients who participate in trials to advance medical knowledge.
Advisory groups investigating this concern and others, including data formats, guidelines for sharing of raw data, good data analysis practices, and legal questions, will deliver proposals on ways to move forward for EMA's proactive transparency policy in April 2013.
