Clinical trials drifting away from Europe

EMA Highlights by Gary Finnegan – The number of clinical trials taking place in Europe and North America continues to fall as research activity in Africa, Asia and South America grows.

In line with a trend that has been developing for more than a decade, the European Medicines Agency (EMA) reports that fewer European patients than ever are taking part in clinical trials submitted as part of European drug marketing applications.

Patients from regions comprising the ‘rest of the world’ – Africa, the Middle East, Asia/Pacific and Central/South America – accounted for 37.3% of the total number of patients recruited for trials on EMA-submitted drugs in 2011.

By contrast, North America made up 31.5% of the trials, while Europe (including Switzerland) was the location for 31.2% of trials. This is the first time that the ‘rest of the world’ has eclipsed Europe and North America, the EMA said.

The report makes particularly grim reading for Europe and Switzerland. While trials have been ebbing away for several years, the rate of decline appears to be accelerating. Figures for 2010 had Europe in first place with 41.6% of the total number of trials. This represents a fall from 66,220 patients to 44,590 in just 12 months.

North America is effectively static, having accounted for 32% of trials in 2010 whereas the rest of the world made up 26.4% of trials submitted to the EMA in 2010.

While the number of European patients included in clinical trials is dramatically down, European and North America still had a higher number of investigator sites than the rest of the world. However, the proportion of investigator sites in Africa and Asia is rising year-on-year suggesting the rest of the world may be poised to overtake their established competitors.

The EMA has been collecting data on the location of trials included in drug marketing applications since 2005 when a new EU directive on clinical trials came into force. The directive was designed to stem the flow of clinical research projects away from Europe but has yet to reverse the trend.

The directive has come in for criticism, particularly from academic researchers who complain that research in Europe is expensive and cumbersome, prompting the European Commission to unveil an overhaul of the Europe’s rules last summer.

All clinical trials included in marketing authorisation applications submitted in the EU have to comply with EU law and with international Good Clinical Practice (GCP) and ethical standards.

The on-going flight of clinical research to fast-growing regions outside Europe and the US led the EMA to begin GCP inspections of research sites in ‘third countries’. The number of routine and triggered inspections has increased by a factor of four between 2006 and 2011.

The EMA is cooperating with authorities in other jurisdictions in an effort to raise the standards of clinical research globally and to ensure patient safety. However, with manufacturing capacity shifting East, European policymakers have cause to be concerned about the flight of pharmaceutical research activity from Europe.