EU clinical trials draft legislation approved by MEPs

Pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database, under draft legislation informally agreed with European Union ministers and approved by Public Health Committee Members of the European Parliament (MEPs) on Wednesday (January 22).

The draft legislation, designed to encourage research whilst protecting patients' rights, is to replace an existing directive with simpler, more uniform rules. The new text makes specific provision for low-intervention trials, clarifies the role of ethics committees in the authorization process, and details how to obtain informed consent from patients.

"For too long, unflattering studies on new medicines have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results. It is vital that we know about negative outcomes - otherwise trials can be conducted repeatedly before it becomes public knowledge that some products are ineffective, or even dangerous," said MEP Glenis Willmott (S&D, UK), who is steering the legislation through Parliament. Her report was adopted unanimously.