On April 2 2014, European members of parliament (MEPs) voted by a huge majority (547 in favour and 17 against) to adopt the Clinical Trials Regulation. The new law, expected to come into effect in mid-2016, will require any new drug clinical trial in Europe to be publicly registered and the results reported, regardless of whether its outcome was positive or negative.
The legislation also calls for a new publicly accessible EU clinical trials register, which will be set up and run by the European Medicines Agency. All drug trials in Europe must be registered before they begin, and results must be summarised on the register within a year of the trial ending. Those who do not comply will be fined.
While the move has been welcomed by those signed up to www.alltrials.net, which was set up to campaign on this issue, there are still concerns that the new law does not affect trials conducted in the past. Dr Ben Goldacre, who leads the Alltrials campaign, said: ‘It does not address the far bigger problem, that we still don’t have full reporting for all trials on the medicines we are using right now, today, medicines which we will continue to use for the foreseeable future.’
The RSS was one of the first organisations to sign up to Alltrials and also welcomes the new legislation. Jenny Freeman, the RSS vice president for external affairs commented, 'We are pleased to see that progress is being made with open access, not only will this benefit patients but also others with an interest in accessing the results of scientific research. However, there is still more to be done and we regard this as being another step to ensuring full access to scientific research information, including information on studies that have already been conducted.'