摘要：s Background Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011–2013. Methods The data elements of “phase,” “recruitment status,” “type of sponsor,” “age groups,” and “design of trial” from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis. Results The USA, Germany, France, Canada, and United Kingdom were the “top five” countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p p p = 0.005), and South Africa (OR 1.963, p Conclusions The globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints.
关键词：Clinical trials ; Intellectual property rights index ; Economic freedom index ; Human capital index ; Health care expenditure per capita
