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European Parliament approves bill to increase clinical trial transparency

28 April 2014

Researchers would have to make results of clinical trials carried out in the European Union public under a bill approved by the European Parliament this month.

The regulation, which now has to be formally approved by the Council of the European Union which represents member states, is expected to come into force in 2016 at the earliest.

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-would have to be uploaded within one year after the end of the trial. 

In addition, researchers must release a full report that contains detailed information about the trial design and analysis, including patient-level data, if the drug is submitted for marketing irrespective of that application's success. Researchers and drug companies will be fined if they fail to comply.