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Monday, April 7, 2014
Finally, a way to track Research Studies: Europe votes for clinical trial transparency
2nd April 2014
It’s soon going to be the law in Europe that drug clinical trials are publicly registered and results reported. MEPs have today voted by a huge majority to adopt the Clinical Trials Regulation, 547 in favour and 17 against. This is fantastic. It will mean that researchers will in future know about trials as they are happening and will be able to scrutinize results soon after their end. This is all due to the efforts of people all over Europe, including many patients who took part in clinical trials, who have pressed their MEPs to set the future straight in this way. Now we want to see recognition and use of the contribution that they and thousands of others have made in the trials that have already been conducted.
The new Clinical Trials Regulation says that information from Clinical Study Reports of trials should not generally be considered commercially confidential and will:
• Require that all drug trials in Europe are registered before they begin on the publicly accessible EU clinical trials register.
• Require that a summary of the results from these trials is published on the register within a year of the trial’s end.
• Require that a summary understandable to a lay person of what was found in the trial is published on the register.
• Require Clinical Study Reports (detailed documents normally produced for regulatory processes) to be made publicly available, where they are produced.
• Establish a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency.
• Require that all trials used in support of an application to run a new clinical trial are registered or have published results.
• Impose financial penalties on anyone running a clinical trial who does not adhere to these new laws.