One last hurdle remaining in clinical trial reform – how you can help | All Trials
abernard102@gmail.com 2014-02-05
Summary:
"The new clinical trial regulation has been approved by Public Health Committee MEPs in Brussels. This means it is one step away from final agreement.
The regulation would require anyone running a clinical trial to register it and publish a summary of results in a publicly accessible EU database. Full Clinical Study Reports are expected to be published following marketing authorisation of the product or if the marketing authorisation is withdrawn. This will be enforced by fines for anyone who doesn’t adhere to the new transparency rules.
Glenis Willmott, the UK MEP steering the legislation through European parliament, said: “For too long, unflattering studies on new medicines 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 some products are ineffective, or even dangerous.”
You have helped get to this stage. The progress of this legislation was helped by the hundreds of AllTrials supporters who wrote to their MEPs in May and Health Ministers in October.
There is one last hurdle to overcome before this legislation becomes law, when it is debated and voted on in the full European Parliament on the 2nd and 3rd of April.
Let your MEP know that you want them to vote for clinical trial regulation.
Find the contact details of your MEP here.
Your letter could sound something like the example below (feel free to copy). Thanks to one of our supporters we also have a Spanish translation of this sample letter ..."