Parliament committee adopts amendments to proposed clinical trial regulation
The European Parliament’s Committee on Environment and Public Health has unanimously adopted reporter Glenis Willmott’s amendments to the Commission’s proposed regulation on clinical trials, including provisions requiring sponsors to publish full clinical study reports once a marketing authorization decision has been taken.
Under the proposals endorsed by the Environment Committee, every trial would have to be registered on a publicly accessible EU database and its main findings reported within a year of the study ending. Non-compliance with the transparency provisions would result in sponsors being fined.
Transparency campaigners such as the AllTrials initiative had been concerned about the lack of measures in the proposed regulation overhauling the Clinical Trials Directive to ensure comprehensive registration and reporting of trials of medicines currently in use.
Willmottt’s proposals only somewhat allay these concerns, though, as the transparency provisions would not apply retroactively.