EU Set To Attract More Clinical Trials With Streamlined Submission Process

By Craig Morgan

Patients can be assured that the medicine they are prescribed has been vetted for safety and efficacy by a long and arduous discovery process guided by governmental regulatory agencies. The central pillar of this rigorous process is the human clinical trial. The success of this model has resulted in a proliferation of clinical trials worldwide. Since the International Committee of Medical Journal Editors (ICJME) established trial registration requirements in 2005, there has been over a tenfold increase in clinical trial registrations globally. However, against this backdrop the European Union (EU) recorded a concerning 25% decrease in clinical trial applications (CTA) from 2007 to 2011, and since 2007 this downward trend in the total number of CTAs and unique trials has continued. Why?