EMA adopts open trial data policy to begin Jan. 1

The European Medicines Agency (EMA) adopted a new policy on Oct. 2 that requires drug companies to make public certain clinical data that predicate drug approvals.

Intended to do away with long-standing secrecy in clinical trials, the transparency policy will be be rolled out in two phases. Beginning Jan. 1, the plan will impact companies that submit drugs for approval to the European regulator on or after that date. For existing medications that are approved for new indications, the rules take effect next July.

The final version of the rule eliminates some restrictions that were in a draft version after open data advocates and scientists criticized the EMA for backpedaling on its original promise of an open data initiative.

Under the newly adopted plan, the public will be able to either browse or search the data on screen or download, print and save the information. That feature was added by EMA's management board in June after critics advocated for more flexibility on how the data could be accessed.

The push toward open data reached a head in 2009 when Roche ($RHHBY) said it would release full clinical trial reports related to its flu drug Tamiflu. Roche never released the data, sparking concerns from patients and researchers over the undisclosed data of other blockbuster drugs.

After EMA announced its intention to open up clinical trial data vaults in 2010, some companies--like AbbVie ($ABBV) and InterMune--retaliated with lawsuits. The EMA reportedly agreed to loosen some of its transparency requirements. But in June, EMA said it revised the policy, adding more "user-friendly amendments."

Still, critics say the final rule does not go far enough to promote transparency in clinical trials. Advocacy groups AllTrials and Sense about Science say the policy puts primary responsibility for redacting information into the hands of pharmaceutical companies, meaning they get to suggest which information submitted to the EMA should be kept hidden.

- see the EMA notice
- read the Q&A on the new policy (PDF)

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