EMA backtracks on clinical trial data download ban

The controversy surrounding the European Medicines Agency's (EMA) trial data transparency draft terms put this week's management board meeting in the spotlight, with campaigners hoping the regulator would rethink its policy. And to an extent, the EMA did, but the compromise it proposed is unlikely to fully satisfy either side of the debate.

In a brief release outlining the management board's conclusions, the EMA said the latest terms will "give the possibility to download, save and print the trial data for academic and non-commercial research purposes." The line appears to overturn one of the most contentious stipulations of the draft terms, which prohibited users from downloading data. Barring researchers from downloading clinical trial data would effectively prevent them from doing useful, meaningful analysis of the results.

The EMA referred to the backlash against the proposed view-on-screen-only access in its release but claims other aspects of its most recent draft terms have broad support. Many will be unhappy if the download U-turn is the only concession the EMA makes, though. European ombudsman Emily O'Reilly also has concerns about the policy on redactions of results and the legal conditions on access and use of the data.

A broader question of why the EMA shifted its thinking on trial transparency remains unanswered. In a release to discuss the board meeting, O'Reilly questioned why the "EMA abandoned its original draft disclosure policy from 2012 and substituted it with a different draft policy, more in line with the pharmaceutical industry's wishes." The role of the deal the EMA struck with AbbVie ($ABBV) in April is being probed, with O'Reilly looking into the legality of the redactions agreed to in the compromise.

- read the EMA release
- and O'Reilly's response
- get FierceBiotech's take

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