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Clinical trials in emerging regions: where is best?

By Kirsty Barnes, 11-Oct-2007

Related topics: Clinical Development, Phase I-II, Phase III-IV

There is much confusion over the competing lure of the four major emerging regions for clinical trials, although each have their pros and cons.

China has a large population of 1.5bn, which is particularly suitable for studies that require a mongoloid population, DA Prasanna, vice chairman & managing director of Manipal Acunova said during a presentation at the recent CPhI trade show in Milan.

 

 

 

The country is also highly useful for conducting Japanese studies, as they are on the same time zone. Another benefit is that China only has one regulatory body, although Chinese is the only language used and translations will be required, said Prasanna.

 

 

 

Taking a look at Latin America, Prasanna said that a "big advantage" of these countries lies in the fact that 50 per cent of the population live in the two top cities, in addition to the time zone being the same as the US. Similarly, Eastern Europe is on the same time zone and within close proximity to Europe.

 

 

 

Both these regions only have a population of 200m-300m and the multiple languages and regulatory bodies involved can present burdens when operating there, Prasanna said.

 

 

 

Although India is the smallest market compared to the other emerging regions, Prasanna said it has a better standard of care than China and the fact that it has a large population (1.1bn), with only one regulatory body and use of the English language, means the country may overtake some of the other emerging regions in the next four to five years.

 

 

 

India's big disadvantages lie in its distance and time zone difference from the west, in addition to the difficulties that lie in getting clinical supplies into India and delivering them to a site, as well as challenges in gathering and maintaining clinical, laboratory and drug accountability data, said Prasanna.

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