Research Letter Examines European Medicines Agency’s Policy on Access to Documents
EMBARGOED FOR RELEASE: 9 A.M. (CT), WEDNESDAY, DECEMBER 19, 2012
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CHICAGO – The European Medicines Agency (EMA) has released more than 1.6 million pages of documents in the first two years of a policy that made a wide range of regulatory documents, including clinical study reports, potentially available to anyone who asked for them, according to a research letter published Online First by Archives of Internal Medicine, a JAMA Network publication.
Beginning January 1, 2014, EMA intends to begin a “proactive” policy on the publication of clinical trial data, according to the research letter and a related commentary that are being published online.
Peter Doshi, Ph.D., Johns Hopkins University School of Medicine, Baltimore, and Tom Jefferson, M.D., of the Cochrane Collaboration, Rome, requested a log of all the requests for documents handled under the agency’s new policy since November 30, 2010 and received a table of 457 requests with details about the document requests.
Requests by the pharmaceutical industry, media and legal affiliates were the majority of the 457 requests. The most frequently requested document types were assessment reports, dossiers and clinical study reports, according to their results.
The authors also used the new policy to receive 25,000 pages of previously unreleased clinical study reports on Roche’s oseltamivir phosphate (Tamiflu) trials, all unredacted, according to background in the research letter.
According to the authors, “the release of such documents contrasts with the approach of the U.S. Food and Drug Administration (FDA), which similarly has a freedom of information policy but treats industry-sponsored clinical trial data as confidential and trade secret, denying public release on the grounds that disclosure could cause competitive harm to original study sponsors.” The authors also comment, “we sought to inform discussion of access to clinical trial data by describing how the EMA’s policy is being used.”
(Arch Intern Med. Published online December 19, 2012. doi:10.1001/jamainternmed.2013.3838. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: Authors made conflict of interest disclosures and disclosed grant funding support. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Commentary: The European Medicines Agency, Brave New World of Access
In a related commentary, Robert Steinbrook, M.D., of the Yale School of Medicine, New Haven, Conn., writes: “As of January 2014, the European Medicines Agency (EMA) will publish clinical trial data for the medications it considers for approval.”
“The EMA will spend most of 2013 determining what is covered by the initiative and other details. Five advisory groups will address the following: (1) protecting patient confidentiality; (2) clinical trial data formats; (3) rules of engagement, that is ‘are there rules or conditions that should be in place before an external stakeholder can download clinical-trial data (e.g., formal acceptance of the need to respect personal data rules, uploading of analysis plans etc.)?’ (4) good analysis practices; and (5) legal aspects, that is “are there any legal aspects other than personal data protection that need to be addressed” and “are there exceptional circumstances under which data can be claimed to be commercially confidential?” they continue.
“The EMA plans to release a draft policy by June 30, 2013, accept public comments through September 30, 2013, and announce its final policy on November 30, 2013,” they conclude.
(Arch Intern Med. Published online December 19, 2012. doi:10.1001/jamainternmed.2013.3842. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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