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Most EU clinical trials patients recruited outside Europe

More than 60 per cent of patients recruited for drug trials submitted to the European Medicines Agency for market authorisation come from outside the European Economic Area and Switzerland, according to a report published on 8 April.

The report, published by the EMA, covers clinical trials carried out for marketing-authorisation applications from 2005 to 2011.

A total of 34 per cent of patients were recruited in North America over that period, although this number decreased from 43 per cent in 2005 to 32 per cent in 2011. Another 28 per cent were recruited outside Europe and North America, with 9 per cent from Central and South America, and 9 per cent from the Middle East/Asia/Pacific regions.

The report concludes that the top three countries carrying out the most large clinical trials, with more than 125 patients, for marketing authorisation are the US, China, and Costa Rica.

The report also finds that very few trials sites can be inspected for good clinical practice. From 1997 to 2011, there were more than 70,000 investigator sites and only 357 were inspected.