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Latin American sites recruit 91% more patients than US

3 comments

By Nick Taylor+

23-Nov-2010

Clinical trials in Latin America recruited 91 per cent more patients per site than studies conducted in the US from 2005 to 2009, according to EU MAA data.

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.

Trial globalisation

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.

3 comments (Comments are now closed)

@Carolynn & Daniel

Pleased to hear you enjoyed the article. The data is for trials included in EU submissions.

Thanks for raising interesting points. Sadly the report doesn't include information on type of site, study etc but I'll try to look into these areas for future articles.

Also, articles taking a deeper look at the data will be published on Outsourcing-Pharma in the coming weeks.

Thanks again,

Nick

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Posted by Nick Taylor
29 November 2010 | 08h58

Other issues in recruitment?

I wonder if we can compare numbers here and if there would be data on a variety of issues. I agree, type of site would be interesting. Type of trials would be of interest. Types of studies. Also, looking at issues such as therapeutic misconception and cultural differences in the relationship of patients to their MDs. GCP training of PIs and staff, etc. Are these FDA trials or EU trials? This is a very compelling article Nick and opens the door enriching discussions that can only enhance best practices of clinical research sites. Certainly training in clinical research is becoming a strong initiative in Peru, Chile and Argentina. I am privileged to be involved in online training courses in PERU.

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Posted by Carolynn Thomas Jones
26 November 2010 | 14h38

Latin America recruitment

Nice article, Nick! It would be interesting to learn about the % of type of sites used in each region ... e.g. private practice, research-only, academic, state-run, hospital, etc. I'm sure they would be differences across the regions showing larger # of patients seen per site in the higher enrolling countries, but that's just my guess.

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Posted by Daniel Weddle
23 November 2010 | 14h53

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