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The globalization of clinical trials is the subject of this analysis to find if there is an increase in non-traditional sites.
Industry observers and industry critics have, in recent years, pointed to the growing use of countries outside the traditional areas of North America and Europe as locations for the conduct of pharmaceutical industry sponsored clinical trials. To the critics in particular this globalization trend presents serious potential ethical and medical issues. Critics has asserted that patients involved in clinical trials conducted in these newer geographies may not be adequately informed. Nor may the site medical people be appropriately trained. Moreover, clinical trials may be conducted in countries which may never receive the study drug if and when it ever comes to the market in the larger markets of North America, Japan, and Europe. A prior question arises though. Are clinical trials actually becoming more global? Much of the confusion about the actual trend comes about because of inadequate data sources behind some of the claims, data sources such as the seriously limited Bioresearch Monitoring Information System (BMIS) 1572 database or ad hoc samples from published clinical trial studies. Fortunately the federally mandated database, ClinicalTrials.gov, presents a more comprehensive data source. Since 2008 site location has been a federally mandated field, with less than 3% missing data for a given site’s country location. In the 1990s there was a significant increase of phase 3 sites in Eastern Europe. The data demonstrate though that there has been virtually no change in phase 3 site location for studies begun and completed studies between 2008-2012. There is a lag in study dates because obviously only completed studies can be included in the analysis. As yet unpublished data through 2014 shows no change in the pattern since 2012.
Harold E. Glass, PhD, Dean's Professor, University of the Sciences in Philadelphia