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Clinical trials for EMA-submitted medicines move away from US and Europe

Most trial patients for drug marketing applications to EMA now come from rest of the world

Clinical trials submitted in marketing-authorisation applications to the European Medicines Agency

From 2010 to 2011, there was a decline in the proportion of patients based in Western Europe and North America involved in clinical trials to support marketing applications to the European Medicines Agency (EMA).

According to the drug regulator for Europe, patients from regions comprising 'rest of the world', including Africa, Middle East/Asia/Pacific and Central/South America, made up 37.3 per cent of the total number of patients recruited for trials investigating EMA-submitted medicines.

This compared to 31.2 per cent for the European Economic Area (EEA) and Switzerland and 31.5 per cent for North America – the first year these regions have both fallen behind the rest of the world.

From year-to-year, the data is most stark for the EEA and Switzerland, which held a proportion of 41.6 per cent in 2010. In number terms, this was a decline in clinical trial patients from 66,220 to 44,590.

North America was less affected proportionally, dropping from 32 per cent in 2010, although patient numbers fell from 51,025 to 44,987.

By contrast, the rest of the world only held 26.4 per cent of patients in clinical trials submitted to the EMA in 2010, while patient numbers rose from 42,105 to 53,384.

Regionally, Central/South America went from 6.2 per cent to 13.6 per cent, former CIS states went from 4.1 per cent to 7.5 per cent, and Middle East/Asia/Pacific went from 12.1 per cent to 12.8 per cent.

In terms of the number of investigator sites involved in pivotal clinical trials support EMA submissions, data was more favourable towards EEA and Switzerland and North America, which in 2011 respectively held 35.2 per cent and 36.7 per cent of all these sites.

This compared to the rest of the world, which held 28.1 per cent, although this was the only region to increase its proportion form 2010 to 2011, suggesting it may overtake both Western Europe and North America soon.

This data has been collected by the EMA since 2005 as part of revisions to pharmaceutical legislation to increase emphasis on the ethical standards required of clinical trials conducted in third countries in response to concerns about how well these trials are conducted from an ethical and scientific standpoint.

According to the EMA, this data has helped improve its approach to good-clinical-practice (GCP) standards by allowing it to allocate resources for inspections where they are most needed.

This has led to an increase the number of GCP inspections in third countries by more than four times from 2006 to 2011.

Download the EMA report

 

10th April 2013

From: Research, Sales, Regulatory

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