| Jerry Boxall of ACM-Pivotal Europe explores the pros and cons of clinical research in the emerging markets from the point of view of a global clinical trials organisation
As the global market continues to expand, pharmaceutical companies must make decisions about which of the key emerging regions to focus on when it comes to clinical trials. Expansion into new markets is nothing new for the pharmaceutical industry, and within Europe we have seen the countries of Central and Eastern Europe (CEE) emerge as major centres for clinical research over the past decade. As with every new opportunity, there are risks associated with conducting research in emerging regions, and a look back at the lessons learnt from the CEE region may be a valuable exercise in identifying potential threats in new locations across the globe.
There is no doubt that momentum is gathering in favour of the emerging economies. According to the Financial Times, the proportion of principal investigators registered with the US Food and Drug Administration – but based outside the US and Western Europe – rose from five per cent in 1997 to 29 per cent last year, with the fastest growth coming from India, China, Russia and Argentina in the past five years (1). These regions are prime clinical trial locations; they offer low cost services, skilled investigators, and a large, diverse pool of highly compliant patients.
Companies that have already explored the opportunities in these new locations have increased patient recruitment by 20 to 30 per cent, whilst also reducing costs. In Phase III trials, research shows that it is common for results to come in six or seven months quicker than in domestic markets – all elements that help to get the drug to market and generate revenue more quickly. However, the globalisation of clinical trials has faced increasing scrutiny over issues such as the quality of data, ethical considerations and the safety of the patients involved. |
