European Parliament Approves Bill to Increase Clinical Trial Transparency
3 April 2014 3:15 pm
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BRUSSELS—Researchers who do clinical trials in the European Union will have to make the results public under a bill approved by the European Parliament yesterday. In a sweeping
vote held here yesterday, 594 members of the Parliament voted in favor of the plan, while only 17 voted against and 13 abstained.
The vote, which confirms an
informal deal reached in December between Parliament and the European Union's 28 member states, is a victory for activist groups who want trials data out in the open. "This is fantastic,” said Sile Lane from Sense About Science, one of the organizations behind the AllTrials campaign in the United Kingdom, in a
statement after the vote. “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.”
Under the draft reform, trials carried out in the European Union must be registered in a central database, and a summary of results—positive or negative—must be uploaded within 1 year after the end of the trial. In addition, researchers must release a full clinical study report—which contains detailed information about the trial design and analysis, including patient-level data sets—if the medicine is submitted for marketing authorization, irrespective of that application's success. Academic researchers and companies would be fined if they don't comply.
http://news.sciencemag.org/europe/2...ves-bill-increase-clinical-trial-transparency
