2011 - 2013年药物介入性临床试验的当前全球化：特征及相关因素
Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011-2013.
作者信息
Jeong Sohyun, Sohn Minji, Kim Jae Hyun, Ko Minoh, Seo Hee-Won, Song Yun-Kyoung, Choi Boyoon, Han Nayoung, Na Han-Sung, Lee Jong Gu, Kim In-Wha, Oh Jung Mi, Lee Euni
机构信息
College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
College of Pharmacy, Sungkyunkwan University, Suwon, Korea.
出版信息
Trials. 2017 Jun 21;18(1):288. doi: 10.1186/s13063-017-2025-1.
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.
背景
临床试验全球化是行业赞助临床试验的一个主要趋势。临床试验地点已转向东欧、拉丁美洲、亚洲、中东和非洲等新兴地区。我们的研究目标是评估当前临床试验的特征，并找出相关的多种因素，这些因素可以解释2011 - 2013年临床试验全球化及其对临床试验全球化的影响。
方法
从ClinicalTrials.gov网站提取30个国家的“阶段”“招募状态”“申办者类型”“年龄组”和“试验设计”的数据元素。选择包括美国在内的10个大陆代表性国家，并将设计元素与美国的进行比较。选择与试验地点分布相关的因素进行多元线性回归分析。
结果
美国、德国、法国、加拿大和英国是经常进行临床试验的“前五”国家。九个大陆代表性国家的设计元素与美国的有很大不同；1期试验在印度更为普遍（比值比1.517，p < 0.001），而3期试验在所有九个代表性国家比在美国更为普遍。波兰（比值比1.852，p < 0.001）、以色列（比值比1.546，p = 0.005）和南非（比值比1.963，p < 0.001）进行的“儿童”年龄组试验比美国更多。多变量分析表明，人均医疗保健支出、经济自由度指数、人力资本指数和知识产权指数可以解释临床试验区域分布差异的63.6%。
结论
亚洲、南非和东欧等新兴地区临床试验的全球化与经济驱动、招募人群和监管限制等因素并行发展。
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