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Pharma clinical data sharing policy comes into effect

GSK and Sanofi among companies to announce public support of new guidelines

EFPIA PhRMA principles clinical trial transparency
A clinical data sharing commitment from companies on both sides of the Atlantic comes into effect today, although the debut has been overshadowed by a damning report on transparency by MPs in the UK.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) drew up the new policy last year amid allegations that unpublished trial data was compromising the ability of healthcare professionals to make judgments on the safety and efficacy of medicines.

Under the new policy, researchers will be able to submit proposals to receive access to patient level data, protocols, and clinical study reports (CSRs) for new medicines approved in the US and EU after January 1, 2014.  

GlaxoSmithKline and Sanofi are among the pharma companies that have already said they will adhere to the new guidelines, with GSK saying it has added anonymised data to an online request system it launched in May 2013.

GSK has gone further than the threshold for transparency set by EFPIA/PhRMA and has indicated it is continuing to post patient-level data from studies going back to the formation of GSK in 2000, with more than 450 studies already available via the gateway.

An independent review panel set up to handle researcher requests had received 16 applications by the end of November 2013 and approved 12, with decisions on the remaining four still pending, said the company, which was the first to sign up to the AllTrials transparency campaign.

EFPIA and PhRMA had scant opportunity to derive capital from their new guidelines, however, as the introduction coincided with a report from the UK Public Accounts Committee (PAC) which slammed pharma's record on transparency.

The report concluded that "information is routinely withheld from doctors and researchers about the methods and results of clinical trials on treatments currently prescribed in the UK".

The PAC is particularly concerned that transparency initiatives fail to take into account medicines that have come onto the market in the past but are still in routine use, and has called on the Department of Health to " ensure that the full methods and results are available to doctors and researchers for all trials on all uses of all treatments currently being prescribed".

Article by
Phil Taylor

3rd January 2014

From: Research, Regulatory

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