EMA delays policy on clinical trial data transparency

The agency will wait until its October 2 board meeting to further clarify wording and practical arrangements

The Management Board of the EMA (European Medicines Agency) has postponed the formal adoption of its policy on publication of clinical trial data, though the agency stopped short of revealing exactly why. 

The agency said it will wait until its October 2 meeting to further clarify wording and practical arrangements, though Board members “have confirmed their general support to the overall aims and objectives of the policy,” including the more user-friendly amendments proposed by EMA Executive Director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.

Rasi’s recommendations represent an about face from the agency’s previous moves to keep data relatively restricted, which was previously a sticking point for the EU ombudsman.

The EMA in May seemed to be cowering to industry pressure and shifting away from increased transparency, saying that it would only allow data to be seen via an interface provided by the agency. But since then, the agency has investigated more user-friendly ways for users to view the data, which has drawn accusations from industry and the US Chamber of Commerce that the efforts might discourage pharma R&D.

The US CoC specifically took issue with the fact that commercially confidential information could not only go public in the EU, but also on an international level, which could spur copycats from foreign countries that seek to replicate the transparency efforts, the CoC contends.

Delays

This latest delay comes as the EMA’s Board “was not able to conclude on the final wording of the policy through a written procedure.” Members of the Board have offered additional contributions which will now be considered and addressed in the next few weeks, the agency says.

The agency also acknowledges the complexity of the debate on both political and technical aspects which have emerged during the previous general and more targeted consultation phases. And over the last year, the EMA says it has tried to balance proactive data disclosure with the need to protect patient data and commercially confidential information.

The new clinical trial regulation will become applicable in 2016 at the earliest and will apply only to clinical trials conducted in the European Union.

The Agency will continue to work with the Management Board and the European Commission ahead of the 2 October meeting to ensure that members receive the clarifications requested and to facilitate the adoption of the policy,” the EMA said.

Related News

Early stage delays are creating a development 'bottleneck', say Georgia Institute of Technology researchers.

How to speed up development: share work with rivals, say scientists

(Picture: Justin Grimes/Flickr)

Trial transparency: NICE stands firm on data

EU Ombudsman raises issue with some of EMA’s redactions of AbbVie data

EU Ombudsman raises issues with some of EMA’s redactions of AbbVie data

Private Eye MD Dr Phil Hammond chaired the transparency debate at PCT in Barcelona last week

Trial transparency's impact opaque say drug and CRO industry experts at PCT in Barcelona

Open data campaigners supported the report. (Image: Justin Grimes)

Institute of Medicine adds voice to calls for trial transparency

EMA defends Humira redactions

EMA defends Humira redactions, says only commercial info was blacked out

Germany’s IQWiG questions transparency of proposed database of EU clinical trial results

Germany’s IQWiG questions transparency of proposed database of EU clinical trial results

WHO calls for Full trial disclosure

WHO says anything short of full trial disclosure skews public spending

EU ombudsman takes issue with trial transparency moves by EMA

EU ombudsman takes issue with trial transparency moves by EMA

EFPIA and PhRMA Endorse EU Regs on Clinical Trial Transparency

EFPIA and PhRMA Endorse EU Regs on Clinical Trial Transparency

GSK, European Parliament Begin Push for Clinical Trial Transparency

GSK, European Parliament Begin Push for Clinical Trial Transparency

Too transparent or too opaque: EMA trial data plans criticised

Too transparent or too opaque: EMA clinical trial data plans criticised