GSK and Sanofi expand transparency
pharmafile | January 6, 2014 | News story | Research and Development, Sales and Marketing | GSK, Goldacre, Sanofi, alltrials, transparency
GlaxoSmithKline and Sanofi have announced separate moves which will shine greater light on both companies’ clinical trial data.
GSK has been something of a ‘poster boy’ for the transparency movement, creating a stir last year when it broke ranks with the rest of pharma to sign up to the AllTrials campaign.
It has now added its anonymised patient-level data from the online request system it launched in May last year to a new multi-sponsor request system (clinicalstudydatarequest.com) that includes studies from many organisations.
GSK was the first pharma company to allow outside researchers online access to detailed trial data.
James Shannon, the firm’s chief medical officer, said: “Enabling researchers to request the studies they are interested in from multiple organisations through one system will, we hope, help further research.”
Meanwhile Sanofi has announced it will expand access to information and data from its own trials – with the caveat that this move only relates to information on products from 1 January this year.
This is in stark contrast to GSK, which is posting studies going back to the formation of the company in 2000.
Yet despite the French manufacturer ignoring the mass of historical data, Sanofi’s move may still be viewed as a significant step. There has been opposition and heel-dragging from pharma in general towards greater transparency, but there appears to be little doubt about which way the wind is blowing.
UK MPs have recently indicated that they are concerned over pharma’s record on data transparency, saying that companies and regulators need to do more.
And the European Union is pushing ahead with its own sunshine measures which, if approved in a vote by European leaders, could lead to:
- A publicly accessible EU database, set up and run by EMA, containing:
- A register of all trials carried out in the EU
- A summary of results for all trials, uploaded one year after the end of the trial at the latest
- Another summary which a layperson could understand
- Clinical Study Reports (CSRs) for all trials used in a marketing authorisation request, whether it is approved, rejected or withdrawn
- A statement that CSRs should, in general, not be considered commercially confidential
- Fines to be imposed by Member States for non-compliance with the transparency requirements
- A requirement for all trials to be registered or published in order to be used to back up a new clinical trial authorisation (will encourage the retrospective registering/publishing of old trials)
- The Clinical Trial Master File retained for at least 25 years.
If agreed by the Member States the overall deal will then need to be approved by the ENVI committee and then the whole Parliament, a process that will take around six months.
Adam Hill
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