12/21/2012 7:45:20 AM
Two years after the European Medicines Agency adopted a new policy that is designed to provide greater access to clinical trial data, a pair of researchers put the regulator to the test and found more than 1.6 million pages of documents have been released, according to a research letter published in the Archives of Internal Medicine. As a result, the researchers wrote the EMA policy toward access to documents is “secret no longer,” an about face after European Ombudsman chastised the regulator more than once for withholding trial data (see this). And their declaration comes not long before another milestone: in January 2014, the EMA will publish clinical trial data for the medications that are being considered for approval. “If the EMA fulfills its promises, a new era of clinical trial data as a public good will begin. Data held by the agency will be available regardless of whether a trial is sponsored by industry, a medical research agency or a foundation, or initiated by investigators,” wrote Robert Steinbrook of the Yale School of Medicine in an accompanying commentary. He adds a caveat, however. That’s because there are two aspects to the release of data. Currently, information the EMA already has requires a specific request, and then the EMA decides what will be release based on its policies. As for publishing trial data, which is to take place as of January 2014, the EMA will spend the next several months sorting out the particulars. “Beyond stating that the initiative is promising and may herald a new era of availability of clinical trial data as a public good, it is difficult to be specific about the potential pros and cons. As they say, ‘the devil is in the details,’ and a draft policy will not be made public for comment until June 2013,” he writes us in an e-mail.