Regulatory Focus™ > News Articles > EMA’s Open Trial Data Policy After Five Years: Long Waits, Lengthy Correspondence

EMA’s Open Trial Data Policy After Five Years: Long Waits, Lengthy Correspondence

Posted 11 February 2016 | By Zachary Brennan 

EMA’s Open Trial Data Policy After Five Years: Long Waits, Lengthy Correspondence

The European Medicines Agency’s (EMA) five-year-old policy of allowing some academic researchers and journalists to access what’s considered commercially confidential information in the US has resulted in a lengthy process that can take considerable back and forth correspondence with the agency, according to a new study.

Since 2010, EMA has allowed clinical study reports to be subject to its “reactive” freedom of information policy, which makes it the only regulator in the world to routinely release such trial data.

But as the number of requests continues to grow -- EMA has released over two million pages of regulatory data -- from 20 requests per month during the first two years to nearly double that (although those requests have since gone down), EMA has had to expand its capacity and in September 2013, launched a 12-person team to deal with the additional requests.

Study Details

A new study, published online Thursday, evaluated 12 requests for regulatory data from EMA linked to 29 different compounds (18 antibiotics, 2 antivirals, 1 monoclonal antibody, 4 vaccines, 1 volume expander, 1 antipsychotic, 1 statin, and 1 antidiabetic). The requests were made from January 2011 to June 2015.

The University of Maryland School of Pharmacy and Cochrane Acute Respiratory Infections Group researchers found that of those 12, there was “great variability in time to receive an initial decision from the EMA (1 to 13 weeks).”

Additional correspondence with EMA was necessary in 10 of 12 requests, and though four of 12 were initially refused, three of those four requests were later allowed on appeal after three to 33 additional weeks. Nine requests were made as academic researchers and three were made as journalists.

“We received data for 11 of 12 requests in 98 batches. While two requests remain outstanding as at June 2015 the remaining nine requests took a median 43 weeks to completion (range: 17 to 186 weeks),” the researchers said. “Despite redaction in 10 of 11 releases (mainly of researcher and participant identifying information), 8 requested were wholly satisfied.”

EMA Improvement

The researchers outlined three possible measures that could address some of the timing and correspondence issues, though they were largely supportive of the idea of having drug regulators be the disseminators of such information:

  • A permanent forum between EMA and requestors may help each side maximize the efficiency of the data request/release process.
  • A publicly available list of holdings by compound name would focus requests and avoid unnecessary correspondence.
  • Release letters could be sent in the body of an email instead of the current practice of email attachments and web-based downloads.

Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency


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