Europe to vote on greater trial transparency
pharmafile | December 17, 2013 | News story | Research and Development, Sales and Marketing | EU, Europe, Goldacre, alltrials, transparency
Pharma companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database, if a deal reached this week is approved.
This is according to Glenis Willmott MEP, the UK Labour party’s leader in Europe, who has been leading negotiations as the European Parliament’s rapporteur on the new clinical trials regulation.
She said: “For too long unflattering studies have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results. It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective, or even dangerous.
“Health and consumer campaigners have been fighting for years for more openness in medicine, and the AllTrials campaign has tens of thousands of supporters.
“But there has been a lot of resistance; the European Medicines Agency is currently being challenged in court by two pharmaceutical companies [AbbVie and InterMune] against their policy of publishing clinical trial data.
“This new Regulation will make it crystal clear that companies and non-commercial organisations must make this information available.”
Willmott adds that the transparency requirements are part of a wider piece of legislation which will streamline the rules on clinical trials across Europe, facilitating cross-border trials to enable larger, more reliable trials, as well those studying rare diseases.
“The improved rules should ensure that Europe maintains and increases the number of skilled jobs in clinical research, whilst continuing to improve treatments for patients,” she continued.
The UK and other EU governments will vote on the overall package on Friday 20 December – it will then need final approval from the European Parliament.
Willmott added: “I am determined to finalise this before the European elections in May 2014. This legislation will set the global gold standard for transparency in clinical trials, and I call on all EU governments to support the agreement on Friday.”
The main points that have been tentatively agreed are:
- 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
- As well as a summary understandable for a layperson
- Clinical Study Reports for all trials used in a marketing authorisation request, whether it is approved, rejected or withdrawn
- A statement that Clinical Study Reports 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.
The UK-based AllTrials campaign group, which has lobbied for the past year for stronger rules to ensure greater transparency, said: “If the EU member states and Parliament agree the additions to Regulation above, it will change the future of clinical trial reporting in Europe and it will be thanks to Glenis and to all of you who wrote to your MEPs and ministers.”
Ben Adams
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