European commission proposes new laws to halt decline in number of clinical trialsBMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e4901 (Published 18 July 2012) Cite this as: BMJ 2012;345:e4901
- Rory Watson
The European Commission has proposed new legislation to remove some of the regulatory burdens on clinical trials in the European Union.1
The legislation will replace rules that have been in place since 2001 and aims to encourage the development of new treatments.
Current procedures have been criticised by patients, researchers, and the drug industry for being excessively bureaucratic. National authorities across the EU have also applied them in different ways. The result has been a sharp decline in the number of clinical trials being conducted in the EU: from 5000 in 2007 to 3800 last year.