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Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013

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Issue Date
2017-06-21
Citation
Trials, 18(1):288
Keywords
Clinical trialsIntellectual property rights indexEconomic freedom indexHuman capital indexHealth care expenditure per capita
Abstract
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 < 0.001) while phase 3 trials were much more prevalent in all nine representative countries than in the USA. A larger number of child age group trials was performed in Poland (OR 1.852, p < 0.001), Israel (OR 1.546, p = 0.005), and South Africa (OR 1.963, p < 0.001) than in the USA. Multivariate analysis showed that health care expenditure per capita, Economic Freedom Index, Human Capital Index, and Intellectual Property Rights Index could explain the variance of regional distribution of clinical trials by 63.6%.

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.
ISSN
1745-6215
Language
English
URI
https://doi.org/10.1186/s13063-017-2025-1

https://hdl.handle.net/10371/117768
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College of Pharmacy (약학대학)Dept. of Pharmacy (약학과)Journal Papers (저널논문_약학과)
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