Europe to create public clinical trial results database after passing law

The European campaign for greater clinical trial data transparency faced a big test this week when the region's politicians voted on legislation. More than 95% voted in favor of the regulations, paving the way for the creation of a publicly-accessible database of clinical trial results.

Lawmakers have tasked the European Medicines Agency (EMA) with creating and running the clinical trial register. As well as requiring that all trials are registered before starting, the regulation will force drugmakers to share their results. A summary must be published within one year of the trial ending, with full clinical study reports being made available once a marketing authorization ruling is made. The requirement to publish clinical study reports--which will make lots of data available to the public and researchers--was not part of the original 2012 draft legislation.

Dr. Ben Goldacre, co-founder of transparency campaign AllTrials, called the regulation "an excellent small step forward," but criticized it for only covering new trials. "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. Doctors and patients simply cannot make informed decisions about which treatment is best, when the evidence on the treatments they are using is still being routinely and legally withheld," Goldacre said in a statement.

Poor compliance with the legislation could also undermine transparency, although authorities have the power to fine companies that fail to meet the data submission timelines. Many drugmakers have also independently moved to open up their data, with GlaxoSmithKline ($GSK) and Johnson & Johnson's ($JNJ) efforts attracting praise for going further than some of their peers.

- read Reuters' take
- here's the AllTrials' statement
- and the EU release

Industry Voices: Clinical trial transparency--time for some carrot as well as more stick?

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