HEALTH : PROVISIONAL DEAL REACHED ON CLINICAL TRIALS REGULATION.

 
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In the future, pharmaceutical companies and academic researchers will have to upload the results of all clinical trials they undertake in Europe to a publicly accessible database, as negotiators from the European Parliament and the Council reached a deal on the clinical trials regulation on 16 December 2013. Member states endorsed the deal on 20 December. This agreement was very much welcomed by transparency campaigners.

"For too long, unflattering studies on new medicines have gone undisclosed," said MEP Glenis Willmott (S&D, UK), rapporteur on the file. "Around half of all trials are never published, usually those with negative or disappointing results. It is vital we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that medicines are ineffective, or even dangerous." Wilmott added that the new legislation "will set the global gold standard for transparency in clinical trials".

Dr Ben Goldacre, co-founder of the transparency campaign 'AllTrials', considered that the deal is "great news," but recalled that the legislation will only cover new trials, starting from 2014. "The vast majority of medicines prescribed today came on the market five, ten or 20 years ago. This new law will do nothing to improve the evidence base for those treatments. We still cannot get all the results of all the trials on even the simplest everyday treatments, the anti-depressants, the statins, the blood pressure treatments and more. Those are the drugs that...

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