Pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database, under a deal approved by a European Parliament committee today.
Glenis Willmott MEP, Labour’s leader in Europe, who has been leading negotiations as the European Parliament’s rapporteur on the clinical trials regulation, 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.
“When a patient makes the decision to take part in a clinical trial, they do so to help advance medicine, to improve treatment for themselves and for those in a similar situation. They do not do it to help a particular company promote a particular drug.
“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 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.
“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.”
The deal was approved by EU governments in December, but still needs approval by the full Parliament, with the vote scheduled for 3 April.
Glenis Willmott MEP 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 am delighted to have the support of EU governments and other MEPs.”