European regulators Struggle with Globalisation of Clinical Trials - Pharmaceutical Technology

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PharmTech Europe

European regulators Struggle with Globalisation of Clinical Trials
The globalisation of clinical trials is putting pressure on the European Medicines Agency.


Pharmaceutical Technology Europe
Volume 24, Issue 6

Summary

The globalisation of clinical trials is now an accepted trend, although not all observers are content about the way it has developed and continues to progress. Documented cases of unethical conduct during clinical trials have led to both public and media outcry, and have prompted calls in the European Parliament for the stronger enforcement of international standards. The EMA has comeunder heavy criticism over its role in overseeing trials conducted on foreign territories, although it argues that it is responding to the need for better regulation and intends to become transparent regarding its future activities in this field.

References

1. F. Thiers et al, Nature Reviews Drug Discovery, 7, 13–14 (2008).

2. S. Glickman et al. N. Engl. J. Med., 360, 816–823 (2009).

3. China Clinical Trials Outsourcing Congress, "Welcome to the 4th Annual China Clinical Trials Outsourcing Congress" (Event website, 2012). http://www.clinical-trials-events.com/, accessed 30 April 2012.

4. J. Aronson, British Medical Journal, 326(7396), 990 (2003).

5. BBC News Anger at deadly Nigerian drug trials. http://www.news.bbc.co.uk/2/hi/africa/6768799.stm <http://news.bbc.co.uk/2/hi/africa/6768799.stm, accessed 8th May 2012

6. BBC News. Pfizer denies dirty tricks claims in Nigeria. http://www.bbc.co.uk/news/world-africa-11971805 <http://www.bbc.co.uk/news/world-africa-11971805 accessed 8th May 2012.

7. The Guardian, 2012. Pfizer pays out to Nigerian families of meningitis drug trial victims. http://www.guardian.co.uk/world/2011/aug/11/pfizer-nigeria-meningitis-drug-compensation <http://www.guardian.co.uk/world/2011/aug/11/pfizer-nigeria-meningitis-drug-compensation, accessed 8th May 2012.


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