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The European Medicines Agency is planning to form advisory groups to look into ongoing issues of access to clinical trial data.

By Ben Steele on Nov 27, 2012

The decision, announced last week at an EMA workshop in London, is part of the wider debate about transparency initiated by Swiss drug maker Roche's refusal to hand over complete trial data for its flu virus, Tamiflu.

Representatives from the European Federation of Pharmaceutical Industries and Associations (EFPIA) were in attendance, along with members of The Cochrane Collaboration, the organization which has been most vocal in calling for greater access to clinical trial datasets. Also present was epidemiologist Ben Goldacre, well known for his book Bad Pharma which criticizes both pharma and regulators for their lack of transparency. The executive director of the EMA, Guido Rasi, stated that the agency "is committed to proactive publication of clinical-trial data, once the marketing-authorization process has ended. We are not here to decide if we publish clinical trial data, but how".

The EMA claims the advisory groups will be formed "with a broad representation from all parties", with a view to establishing policies in five key areas: "protecting patient confidentiality; clinical-trial data formats; rules of engagement; good analysis practice and legal aspects". Work will start on these topics from early 2013, with final advice being given in April that year and the proactive publication of clinical trial data expected to start on January 1, 2014. The UK government will also be conducting its own investigation into pharma's withholding of clinical trial data over the next year "as a matter of priority", according to the chair of the Health Select Committee Stephen Dorrell.

The workshop comes after an earlier decision by the EMA to allow access to its data vaults, after it reclassified clinical trial data as no longer commercially confidential. However, one issue the workshop was set up to discuss was the fact that some of the trials contain patient data that had not been randomized. The European pharma lobby group EFPIA has called for "a measured approach" to complete transparency on clinical trial data, saying it wanted to maintain patient trust and privacy.

Roche put forward its own solution on how to handle the Tamiflu debacle last week. It offered to set up a multi-party advisory board of its own to review its clinical trial data for the flu vaccine and determine the future of Tamiflu. Earlier this month the British Medical Journal published a letter from the director of the nonprofit Nordic Cochrane Centre, Peter Gotzsche, calling for a boycott on Roche's products until they release all clinical trial data for the drug. Roche pharma Chief O'Day told Reuters that "[t]o what level data will be shared proactively and constantly is something we need to discuss."