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Over half of trial patients in EU marketing submissions are from third countries

This article was originally published in SRA

Executive Summary

Some 61% of the patients who took part in the pivotal clinical trials used to support marketing authorisation applications submitted to the European Medicines Agency between 2005 and 2009 came from third countries, a report by the agency has revealed1. In addition, since 1997, good clinical practice inspections have been requested for only 228 of the 44,034 investigator sites counted as part of the pivotal trials in these MAAs, illustrating the very small sample of sites that are, or can be, inspected.

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