In 2004 the European Medicines Agency (EMA) began collecting information about where pivotal trials included in marketing authorisation applications (MAA) were conducted. Data from 2005 to 2009 has been published in a report looking at the globalisation and standards of clinical trials.
Over this period MAA submitted to the EMA included data from 478 clinical trials conducted in the US. These 478 clinical trials used 17,308 sites to recruit 182,088 patients. On average, meaning arithmetic mean, each site in the US recruited 11 patients.
In contrast, data from 536 clinical trials conducted in Central and South America was included in EMA MAA from 2005 to 2009. These trials used 2,625 sites to recruit 54,657 patients. This gives an average of 21 patients per site, 91 per cent greater than studies conducted in the US.
From 2005 to 2009 61 per cent of patients in pivotal trials submitted in MAA to the EMA were from outside the European Union (EU). North America accounts for 35 per cent of patients and the rest of the world (ROW) for 26 per cent.
Breaking this down further, 7.8 per cent of patients were from trials conducted in the Middle East, Asia and Pacific regions, and 9.2 per cent of study participants were from Latin America.
Individual non-EU countries of note include South Africa, Brazil, Argentina and Russia. Trials conducted in each of these countries contributed more than two per cent of total patients in EMA MAA.
Outsourcing-Pharma will further explore this data and other information from the EMA report in upcoming interactive visualisations.