A leading researcher has urged the EU to push for international cooperation on clinical trials regulation, after the European Medicines Agency confirmed the likely suspension of 700 drugs because of misconduct in India.
On 22 May, the EMA reiterated its recommendation to revoke the use of medicines that were authorised based on trials by GVK Bio, a contract research organisation, at a facility in Hyderabad. According to Ian Roberts, who directs the clinical trials unit at the London School of Hygiene and Tropical Medicine, this is strong evidence that global action is needed.
“We need to harmonise our approach and get the information system on drugs right, and for that we need international cooperation,” says Roberts. “We should have a proper trial protocol and analysis plan prospectively registered and published online, so that the data are available for public scrutiny.”
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