Joint Research Office


New European legislation on clinical trials published

24 June 2014

A new regulation formally approved this month should make clinical trials simpler to set up and more transparent in reporting their results.

The regulation replaced the previous Clinical Trials Directive, introduced in 2001.

A notable change is the introduction of a centralised system for approving clinical trials, meaning that researchers who run trials in several countries need apply only once for approval, to a portal set up by the European Medicines Agency. Previously, researchers had to apply separately to each country included in a multinational trial.

The new regulation aims to increase transparency by requiring the publication of results, including negative findings. All trials in the EU must be registered on a publicly accessible clinical trials database established by the European Medicines Agency as part of the central portal. A summary of results must be uploaded within one year of a trial ending, and the full study reports must be uploaded if a medicine is submitted for marketing authorisation.

Another change is that the new regulation will enable data collected in a clinical trial to be used in further research after the study has ended. Clinical trial participants will be able to give 'one time' consent for data to be used for research beyond the trial, rather than researchers having to gain further consent to use data in subsequent studies.

Martyn Ward from the MHRA Clinical Trials Unit will give a summary of the regulation on Monday 17 November 2014 in 33 Queen Square - more details to follow nearer the time.

To read Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance click here.