EU trial rules stall research

European clinical trial guidelines meant to make trials safer and more efficient are actually slowing down studies that could help patients, and even dissuading researchers from launching trials at all, according to an opinion published online today (November 16) in PLoS Medicine.

Image: Wikimedia commons, S. Solberg J.

The European Union's Clinical Trials Directive, adopted in 2004, says that trials evaluating investigational medicinal products should follow Good Clinical Practice (GCP), an international quality standard for human clinical trials. According to linkurl:Alex McMahon;http://www.fom.gla.ac.uk/research/profile.php?id=4cdbe7ed8b95 of the University of Glasgow in Scotland and his colleagues, who wrote the opinion piece, the stringent definition of GCP employed in the Directive makes sense for trials sponsored by biopharma companies, which are generally developing new medicines, but not for trials run by academic medical centers, which more often are studying already-licensed drugs in order to fine-tune their use in the clinic. Although the regulatory suggestions...