EMA publishes report on Pivotal Clinical Trials

April 11, 2013 | By Márcio Barra

EMA, the European Medicines Agency, just published the third edition of their report on pivotal trials included in MAA’s submitted to the centralized procedure, ranging from January 2005 to December 2011 (including generic drug pivotal trials).

It contains lots of good information, like number of patients, what regions have the most investigator sites, and trends relating to the mentioned time period. It’s worth noting that this report only regards pivotal trials, so supportive trials, like phase I, II, some phase III, and phase IV are not included. Only trials for new applications (485), line extensions (95) and variations where new clinical trial information was provided (97) are included in this report, totaling 677 trials. Five were excluded as they had a huge number of patients recruited, which could obscure the analysis.  Also, this information was recorded against the year in which the MAA was submitted, so patients would actually have entered the trials in preceding years (1-5 years earlier)

Now, for the highlights:

From 2005 to 2011, 897,891 patients were recruited to pivotal trials:

  • 38.1% come from the EU/EEA/EFTA
  • 34.1% from North America
  • 9.4%.from Central/South America and Middle East/Asia/Pacific
  • 4.4% from the CIS region (Commonwealth of Independent States)
  • 2.6% from Africa
  • 1.5 % from Australia-New Zealand
  • 0.5  from Eastern Europe-non EU

The Middle East / Asia / Pacific increased from 2.0% in 2005 to 12.8% in 2011, The CIS region increased from 0.8% in 2005 to 7.5% in 2011, North America decreased from 42.8% in 2005 to 31.5% in 2011 and the EU / EEA / EFTA decreased from 37.0% in 2005 to 31.2% in 2011. These numbers shouldn’t come as a surprise to anyone familiar with the current trends. The past few years more and more trials were being done in regions outside the EU and US, and pivotal trials are no different, especially when you consider that these trials usually require a lot of patients.

In the EU/EEA/EFTA region the major contributors were Germany (6.8%), Poland (3.9%), France (3%), Finland (2.9%), Italy (2.3%), Spain (2.2%) and UK (2.1%). Czech Republic, the Netherlands, Belgium and Hungary contributed between 2% and 1.5% of the total number of patients. Sweden, Denmark, Austria and Lithuania contributed between 1.4% and 0.5%, by descending order.

A short detour now. When I was going through the list, I thought: “Where is Portugal?”

A look to the rest of the report shows that Portugal, regarding the number of pivotal clinical trials in MAA submitted to EMA performed in North America and EU/EEA/EFTA, is at the 22th position, with only 80 trials. Belgium, a country with similar dimensions to Portugal, had 239 pivotal trials. The short number of pivotal trials in Portugal explains why it isn’t a big enough contributing factor to the number of patients recruited. The average number of patients recruited by Portugal was only 23, third to last on the list after Switzerland (22) and Ireland (18).

As for the number investigator sites in pivotal trials, EU/EEA/EFTA had a total of 25, 420 sites, North America 29,807 (26,701 in the USA and 3,106 in Canada), and the rest of the world had 15,064 sites. Middle East/Asia/Pacific grew the most through the years in the number of sites.

Lastly, GCP inspections by national competent authorities of the EU / EEA Member States in Third Countries increased by more than four times between 2006 and 2011.

A total of 357 sites were inspected at the request of the Agency’s Committee for Medicinal Products for Human Use (CHMP) between 1997 and 2011. Most of them took place in 2007. The pivotal trials submitted between 2005 and 2011 involved 70,291 investigator sites.

The countries outside the EU / EEA / EFTA area with the highest number of requested inspections were the United States (21.6%), followed by India (4.5%), Canada (4.5%), Russia (3.1%), Argentina (2.2%) and China (1.7%).

The top three countries where bioequivalence trials for generic applications were inspected were India, Italy and Canada.

For more information and some handy graphics, access the report through here: Link

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