Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013
Abstracts 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 ch...
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| Format: | Article |
| Language: | English |
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BMC
2017-06-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2025-1 |
| _version_ | 1828390274037972992 |
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| author | Sohyun Jeong Minji Sohn Jae Hyun Kim Minoh Ko Hee-won Seo Yun-Kyoung Song Boyoon Choi Nayoung Han Han-Sung Na Jong Gu Lee In-Wha Kim Jung Mi Oh Euni Lee |
| author_facet | Sohyun Jeong Minji Sohn Jae Hyun Kim Minoh Ko Hee-won Seo Yun-Kyoung Song Boyoon Choi Nayoung Han Han-Sung Na Jong Gu Lee In-Wha Kim Jung Mi Oh Euni Lee |
| author_sort | Sohyun Jeong |
| collection | DOAJ |
| description | Abstracts 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. |
| first_indexed | 2024-12-10T06:41:23Z |
| format | Article |
| id | doaj.art-744832c6fb1f4ac3825f2ab610cdf4a7 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T06:41:23Z |
| publishDate | 2017-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-744832c6fb1f4ac3825f2ab610cdf4a72022-12-22T01:58:46ZengBMCTrials1745-62152017-06-011811810.1186/s13063-017-2025-1Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013Sohyun Jeong0Minji Sohn1Jae Hyun Kim2Minoh Ko3Hee-won Seo4Yun-Kyoung Song5Boyoon Choi6Nayoung Han7Han-Sung Na8Jong Gu Lee9In-Wha Kim10Jung Mi Oh11Euni Lee12College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityClinical Research Division, Toxicology Evaluation and Research Department, National Institute of Food and Drug EvaluationClinical Research Division, Toxicology Evaluation and Research Department, National Institute of Food and Drug EvaluationCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National UniversityAbstracts 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.http://link.springer.com/article/10.1186/s13063-017-2025-1Clinical trialsIntellectual property rights indexEconomic freedom indexHuman capital indexHealth care expenditure per capita |
| spellingShingle | Sohyun Jeong Minji Sohn Jae Hyun Kim Minoh Ko Hee-won Seo Yun-Kyoung Song Boyoon Choi Nayoung Han Han-Sung Na Jong Gu Lee In-Wha Kim Jung Mi Oh Euni Lee Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013 Trials Clinical trials Intellectual property rights index Economic freedom index Human capital index Health care expenditure per capita |
| title | Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013 |
| title_full | Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013 |
| title_fullStr | Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013 |
| title_full_unstemmed | Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013 |
| title_short | Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013 |
| title_sort | current globalization of drug interventional clinical trials characteristics and associated factors 2011 2013 |
| topic | Clinical trials Intellectual property rights index Economic freedom index Human capital index Health care expenditure per capita |
| url | http://link.springer.com/article/10.1186/s13063-017-2025-1 |
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