Regulatory Focus™ > News Articles > Report: EMA to Make Public All Clinical Trials Data

Report: EMA to Make Public All Clinical Trials Data

Posted 16 July 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is set to unveil a measure to substantially increase the transparency of clinical trials data collected by the European regulator as part of its medicines approval process, reports Reuters.

The new transparency measures would vault the agency ahead of its US counterpart, the US Food and Drug Administration, which currently does not require clinical trials data to be made public, though the existence of the trials themselves are posted on www.clinicaltrials.gov.

Reuters writes the plan will be unveiled at a November 2012 conference and will include discussion of how to make the data sets available to the public "rapidly and routinely." Clinical trials data sets can be enormous, particularly for multi-center and trans-national trials. The agency hopes to make the release of such data standardized, with protections in place to protect the anonymity of patients.

A 'Sea Change in Attitude'

EMA's Chief Medical Officer Hans-Georg Eichler called the move a "sea-change in attitude" with the potential to add a layer of transparency to both the regulatory agency's decisions and the claims made by industry about its products. "I hope everybody will learn that daylight is the best disinfectant and this will be a contributing step in rebuilding trust in the regulator and in the industry," Eichler told Reuters.

The move could also see medicines subject to a heightened amount of public scrutiny-possibly to the public's benefit. Reuters notes many of the industry's largest settlements have dealt with missed safety signals and data withheld from regulators. Studies would still be gated until the agency has reviewed a drug's data as to prevent premature studies from changing public behavior either for or against a drug.

The transparency measure is one of several undertaken in recent months by EMA, including making conflicts of interests for all EMA employees a matter of public record and instituting safeguards to prevent conflicted staff from reviewing medicines.


Read more:

Reuters - EU agency lifts lid on drug data secrets

Pharmalot - EMA To Make Clinical Trial Data Available


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