Phase III patient enrollment represents one of the most critical business issues facing the pharmaceutical industry. In recent years there has been extensive discussion about the growing use of newer geographies for Phase III clinical study sites. Many of these newer geographies in areas such as Asia, South Asia, Latin America and Africa may represent increasingly attractive commercial markets for pharmaceutical companies. But more critically for drug development professionals, these areas present the prospect of large pools of medially naïve patients who can be enrolled at quicker rates and at lower costs. At many conferences speakers, particularly from larger pharmaceutical companies and CROs discuss the opportunities and challenges for clinical trial completion represented by these new geographies.  

Clinical site selection is primarily driven by that site’s ability to enroll and tread patients in accord with the study protocol. Certainly though a market’s commercial attractiveness may also be a consideration. Larger pharmaceutical companies are probably better equipped to launch drugs in the newer geographies. The data from the federally mandated fields in ClinicalTrials.gov do show that the very largest pharmaceutical companies are more likely to conduct clinical trials outside the traditional geographies of North America. But like the rest of the industry, most of the clinical trial activity remains within North America and Europe. Moreover, there has been no appreciable increase in the use of newer geographies by either larger or smaller companies.

Harold E. Glass, PhD, Dean's Professor, University of the Sciences in Philadelphia