October 2, 2014 / 6:37 PM / 5 years ago

EU agency adopts plan to cut clinical trial secrecy

LONDON (Reuters) - Europe’s medicines regulator has endorsed a scheme to publish detailed clinical reports underpinning new drug approvals from next year, though campaigners for full transparency said they were concerned some data would still be missing.

The London-based European Medicines Agency (EMA) has been at the center of a row about divulging trials data for the past two years, following concerns over undisclosed data for certain drugs such as Roche’s flu pill Tamiflu.

Critics of the pharmaceuticals industry argue that free access to such data is essential, so that independent experts can test claims made about prescription drugs. But some companies have fought to keep the information private.

The EMA — Europe’s equivalent of the U.S. Food and Drug Administration — said on Thursday its management board had unanimously adopted a policy to publish all clinical reports for new drugs from 2015.

Importantly, outside researchers will be free to download and save the information, allowing them to reassess large data sets — something the EMA had at one stage been reluctant to permit.

Tracey Brown, managing director of the group Sense About Science, which has campaigned against clinical trials secrecy, said she was pleased the EMA had reversed a “ridiculous” proposal that would have meant researchers could only see information from clinical trials on-screen in a sealed room.

“However, it is still the case that trial sponsors (drug companies) can cut out any information they don’t want others to see,” she said.

The agency’s new policy states that “in limited instances”, information that may be considered commercially confidential will be redacted from the clinical reports.


In the case of Tamiflu, researchers fought for years to get full data from Roche in the belief that governments who stockpiled it were wasting billions of dollars on a drug whose effectiveness was in doubt. Roche has always insisted its medicine has clear benefits.

Other firms, meanwhile, have tried to stop previous EMA moves to release drug information, with AbbVie challenging a plan to give outsiders access to data on its top-selling rheumatoid arthritis medicine Humira. AbbVie later withdrew a lawsuit after the EMA agreed to keep certain commercially sensitive information secret.

Guido Rasi, the EMA’s executive director, said the balanced approach now adopted by the agency set a new standard for transparency and would increase public confidence in its decision-making process.

“This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry,” he said in a statement.

The new transparency program will be implemented in phases, with clinical reports to be published for all new drugs submitted for approval from Jan. 1. For new uses of existing medicines, the rules take effect from July 1.

The EMA also plans eventually to make available anonymised individual patient data, but said it would first hold further consultations to address various legal and technical issues.

Ben Goldacre, a British doctor and author who has led a campaign called AllTrials urging study disclosure, said the EMA move was a step forward but there would still be major gaps in clinical trials data.

The EMA only holds clinical study reports for a small proportion of all the trials done on all the medicines used by doctors today and there was still a need for a radical overhaul giving retrospective transparency, he said.

Editing by Keiron Henderson

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