A report published by the European Medicines Agency shows that, although Europe’s share of global clinical trial participants has dropped since 2005, the region is now level with the North America, where the decline has been steeper.
The report covers pivotal clinical trials used to support MAA applications to the EMA, noting that this relates mostly to Phase III trials and that the data is counted for the year of MAA submission, which could be several years after trial recruitment actually took place.
The data shows that patients in Europe fell from 37.0% in 2005 to 31.2% in 2011. However, patients from North America fell from 42.8% to 31.5% over the same period. The contribution from Middle East/Asia/Pacific rose from 2.0% to 12.8% while the proportion of patients from CIS rose from 0.8% to 7.5%.
It is also interesting to note that within Europe the distribution of patients also shifted significantly: the countries that had been members of the EU prior to 2004 contributed only 19.4% in 2011 compared with 32.1% in 2005, while incoming states (mostly in Eastern Europe) increased from 4.7% to 11.7%.