May 12, 2012 Volume 379 Number 9828 p1763 – 1850 e50 – 51
Re-engineering the European Union Clinical Trials Directive
MJH Kenter, AF Cohen
The European Union Clinical Trials Directive 2001/20/EC (EU CTD), which was introduced in 2004 for drug trials, aims to protect European citizens who take part in research, safeguard data quality, and harmonise the review of clinical trials. Unfortunately, the directive is based on an ill-defined, two-tier assessment system in which two review bodies—a national competent authority and a research ethics committee (REC)—both evaluate the same clinical trial application in every member state. The European Commission is currently considering a revision of the EU CTD, but this will simply build further on the current directive’s flawed foundations.