Europe votes for transparency in future clinical trials

peter.suber's bookmarks 2014-04-13

Summary:

"The European Parliament has voted for a new law that will make results from clinical trials more easily available. 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' ..."

Link:

http://www.statslife.org.uk/news/1353-europe-votes-for-transparency-in-future-clinical-trials

From feeds:

Open Access Tracking Project (OATP) » abernard102@gmail.com
Open Access Tracking Project (OATP) » pontika.nancy@gmail.com's bookmarks

Tags:

oa.biomedicine oa.medicine oa.policies oa.legislation oa.europe oa.ema oa.clinical_trials oa.data oa.comment oa.new ru.sparc oa.pharma

Date tagged:

04/13/2014, 09:10

Date published:

04/13/2014, 06:23