EMA Gearing Up for Transparency

The European Medicines Agency is preparing for a new policy that will release rarely-seen clinical trial reports for independent scrutiny.  

By | June 16, 2014

WIKIMEDIA, CHAOSClinical trial reports include massive amounts of data on an investigational therapy, but they are rarely made available for independent researchers to analyze. In a move toward greater transparency, the European Medicines Agency (EMA) has been working on a policy to make these reports more readily available. Last week (June 12), the agency announced that its management board had updated the rules to make accessing the reports more user-friendly, allowing researchers to download them.

“This is a good move,” Síle Lane from Sense About Science, a group that aims to represent the public interest in science, said in a statement. “It will mean researchers will be able to scrutinise, compare and share clinical trial information. Allowing researchers access to clinical trial information on-screen-only would have made their job impossible.”

Advocates for transparency are still concerned, however, that the EMA has scaled back its original plans for having companies disclose clinical trial reports and has given more confidentiality protections to drugmakers in a new draft policy that came out this spring. In a statement to ScienceInsider, European Ombudsman Emily O’Reilly said the draft language “imposed broad legal conditions” on users and “only allowed limited access to clinical trial data by redacting significant information.” According to The Wall Street Journal’s Pharmalot, “instead of the forceful approach the EMA had been signaling—and in fact, had begun to put in place two years ago—the contents of the draft suggested a retreat.”

The EMA said in its announcement that the policy goes beyond the agency’s “legal obligations and provides an unprecedented level of access to clinical trial data that are used as part of decision-making for new medicines.”

Add a Comment

Avatar of: You



Sign In with your LabX Media Group Passport to leave a comment

Not a member? Register Now!

LabX Media Group Passport Logo

Popular Now

  1. That Other CRISPR Patent Dispute
    Daily News That Other CRISPR Patent Dispute

    The Broad Institute and Rockefeller University disagree over which scientists should be named as inventors on certain patents involving the gene-editing technology.

  2. How Gaining and Losing Weight Affects the Body
    Daily News How Gaining and Losing Weight Affects the Body

    Millions of measurements from 23 people who consumed extra calories every day for a month reveal changes in proteins, metabolites, and gut microbiota that accompany shifts in body mass.

  3. Neurons Use Virus-Like Proteins to Transmit Information
  4. DOE-Sponsored Oak Ridge National Laboratory to Cut 100 More Jobs