A recent analysis from the European Medicines Agency shows that 62 percent of the patients in pivotal trials were recruited outside of the European Economic Area.
The report on clinical trials submitted in MAAs to the European Medicines Agency, published on April 9th, provides an overview of the distribution of the numbers of patients, investigator sites and pivotal clinical trials included in MAAs submitted to the Agency, as well as the number and location of sites that were inspected.
More than a third of the patients were enrolled in North America, while almost 28% were recruited in Africa, the Middle East, Asia, the Pacific, Australia, New Zealand, Central or South America, the Commonwealth of Independent States (CIS) or non-European Union (EU) Eastern Europe. Of note, 9.4% of patients were recruited in the Middle East, Asia or the Pacific and another 9.4% in Central or South America.
Major trends in the number of patients submitted in MAAs to the European Medicines Agency during the observation period were: Middle East / Asia / Pacific: an increase from 2.0% in 2005 to 12.8% in 2011 and CIS: an increase from 0.8% in 2005 to 7.5% in 2011.