EMA urged to make trial data transparency policy crystal clear

By Gareth Macdonald contact

- Last updated on GMT

EMA management board meet in London, UK today
EMA management board meet in London, UK today

Related tags: Clinical trial data, Clinical trial, Pharmaceutical industry

Campaigning group Alltrials has reiterated its call for the EMA to prevent "excessive redaction" and to let researchers print clinical trial data without fear of litigation ahead of the Agency’s vote on its access policy later today.

When the European Parliament passed laws requiring that all clinical trial data should be published in April​ it tasked the European Medicines Agency (EMA) with developing a way of making the information available to healthcare researchers.

The EMA’s first access plan – published in June​ – attracted considerable criticism from transparency campaigners who said that only letting researchers view data online and requiring that they sign usage restrictions that would open them up to drug industry litigation was a backwards step.

Days later the EMA revised its plan​, dropping the screen only access plan and adopting “more user-friendly amendments​.” The agency also put back its final vote on its access policy until today to allow further discussion.

Alltrials' transparency position clear

Alltrials, which wants all clinical trials, past and present, to be registered and results reported, was in favour of the EMA’s change of plan and reiterated its call for the EMA to make all clinical trial data available in a letter sent to the Agency’s management board in August​.

We are pleased to hear that Board members support “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.”

“We urge you to support these amendments and reject earlier versions of the policy that would mean that Clinical Study Reports [CSR} would only be available for viewing on screen. This restriction would make it nearly impossible for researchers to usefully scrutinise the documents.

“Your policy on access to CSRs as initially proposed could have made a genuine contribution to medical research. By limiting access to on-screen viewing it risks becoming a superficial and practically useless gesture.

Concerns

The campaigning group was less pleased about the so called ‘redaction principles’ included in the EMA policy issued in July, arguing that the wording is “ambiguous, and where there is ambiguity, there is likely to be excessive redaction.

Similarly, Alltrials has concerns about ‘terms of use clauses’ researchers accessing the data would be required to sign. The campaigners said the “contains clauses that seem to prioritise trial sponsors’ legal rights over researchers’ need to scrutinise and use information.”

More recently, Alltrials has used various social media campaigns to underline its view on trial transparency with the latest being a tweet sent by founder @Bengoldacre to his 346,000 followers last night.

 

bengold

CRO impact

For the CROs that run trials on behalf of sponsors the outcome of the EMA's transparency policy vote is likely to have minimal impact according to ACRO spokesman Jon Lewis.

He told Outsourcing-pharma.com the transparency debate "has not been a major issue for CROs as we do not own the data; rather the sponsor does​."

However, ACRO members do back the data sharing principles favoured by industry groups EFPIA and PhRMA according to Lewis, who said: "From an operational standpoint, we want to ensure patient privacy is protected and that any potential disclosure of data is adequately addressed in the informed consent process​."

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