Parliament passes clinical trial rule

MEPs have passed a regulation that stipulates that summary reports from all clinical trials conducted within the EU must be published within a year of trial completion.

The clinical trials regulation, passed on 2 April with 594 votes in favour and 17 against, also requires that all drug trials be registered on the EU clinical trials registry prior to commencing. This publicly accessible EU register is to be set up and maintained by the European Medicines Agency.

The regulation will replace the 2001 clinical trials directive, which has been criticised for what some have described as disproportionate regulatory requirements and a lack of coordination of rules for trials taking place across multiple countries.