With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.
In a proactive move to take advantage of lower costs and treatment-naïve populations, many biopharmaceutical companies are looking beyond western Europe, with the expectation that the proportion of investigators will continue to shift in the direction of emerging African, Latin American and Asia Pacific ‘hot spot’ regions. Recent reports reveal that 8.5 percent of active FDA regulated investigators are based in central and eastern Europe, with Latin America and Asia following closely behind at 5.5 percent each. In the coming years, additional markets will continue to emerge, thanks largely to the growing number of GCP-trained investigative sites in developing markets. This globalising trend, coupled with biopharmaceutical companies’ narrowing concentration to core competencies, has resulted in more outsourcing activity to the CRO market. The percentage of outsourced research and development expenditures has grown from 21.7 per cent in 2006 to a projected 28.3 percent by 2010. Meanwhile, the number of startup biopharmaceutical companies continues to grow – largely due to increased investment funding and the lack of solid development pipelines in many of the larger companies – and it is expected that most of these startups will outsource all development activities.