New European legislation on clinical trials is publishedBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g4102 (Published 18 June 2014) Cite this as: BMJ 2014;348:g4102
- Susan Mayor
Clinical trials in Europe should be simpler to set up and more transparent in reporting their results, after a new European Union regulation1 that sets the clock ticking for the recommendations to become law in all member states in 2016.
The regulation replaced the previous Clinical Trials Directive, introduced in 2001, which many people have blamed for a substantial decrease in clinical trials in the EU over the past decade.
A notable change was 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 …