EMA reports on patient recruitment and geographical location of clinical trials

Almost 62% of the patients in pivotal trials submitted in marketing-authorisation applications (MAAs) to the European Medicines Agency between January 2005 and December 2011 were recruited outside of the European Economic Area (EEA) and Switzerland, according to an analysis performed by the Agency.

More than 34% of 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.

The EMA closely monitors the data that applicants must include in their MAAs on the location of studies and the ethical standards applied in respect of clinical trials conducted outside the European Union. Applicants have had to include this information since the revisions to the European pharmaceutical legislation in 2005, which reinforced the emphasis on ethical and good clinical-practice (GCP) standards.