Friday, April 19, 2013

Globalized Clinical Trial Solutions


The discussion here is that 'Is it positive to have more globalised clinical trial locations’?

Clinical trial locations are no longer restricted to a handful of key scientific bases in the UK, US and Europe. In the first of our occasional series, we look at how this movement has impacted global skills needs. 

The horrific incident at Northwick Park Hospital in 2006 that left clinical trial lists critically ill not only shocked the British public, it coincided with a shift change in the type of subjects happy to take part in certain kinds of drug trials and, more pertinently, where those trials are now held. 

Emerging markets in Japan, Korea, India, Mexico and various Eastern European countries have radically changed what clinical trials are happening where, with whom and why. 

Local regulations are increasingly stringent and the sheer cost of running a clinical trial in the UK, France or the US is making it harder to justify and secure funding. 

Moving East is one way of getting round this. Foreign clinical trials create job opportunities for researchers, scientists and medical personnel. They can also lead to new therapies being available. 

Some locations make better sense for particular drug tests because of the prevalence of certain conditions and illnesses in those regions. 

And, of course, there can be financial advantages for companies dealing with budget restrictions. According to one study, the cost of conducting biomedical research in China is only around 20% of the cost for similar trials in the West.                                             (Source:http://www.pharmafocusasia.com/clinical_trials/biotech_trials_asia.htm

Is this a good thing? We know there are real concerns about how different populations affected by poverty, prevalent diseases etc. may metabolise drugs differently. How does that affect the skills needed to apply these study results to medicines on sale elsewhere around the world? 

Then there are the regulatory hitches and differences in local legislations. So do you feel it is positive to have more globalised clinical trial locations? Are pharma companies exploiting a less aware set of subjects and are the results always transferrable and reliable?

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