Rodríguez-Feria Pablo, Cuervo Luis Gabriel
Office of Knowledge Management, Bioethics, and Research Pan American Health Organization (PAHO) / Regional Office of the World Health Organization (WHO) Washington, DC United States of America Office of Knowledge Management, Bioethics, and Research, Pan American Health Organization (PAHO) / Regional Office of the World Health Organization (WHO), Washington, DC, United States of America.
Rev Panam Salud Publica. 2017 Mar 23;41:e31. doi: 10.26633/RPSP.2017.31. eCollection 2017.
This descriptive study identifies trends in clinical trial registration in the World Health Organization International Clinical Trial Registry Platform (ICTRP) for Latin America and the Caribbean (LAC), from 2007-2013, and provides adjusted estimates for registration rates by population and publications (2007-2011). Trends and data are presented by subregion and language in interactive graphs, including annual registration rates by population (2007-2011) and publications (LILACS and MEDLINE) listed in SCIENTI Network (Science and Technology Indicators). Of the 11 945 clinical trials involving LAC countries, 8 282 were in South America, with Brazil leading at 4 070 (49%); 2 421 in North and Central America, with Mexico leading at 1 886 (78%); and 1 242 in the Caribbean, with Puerto Rico leading at 857 (69%). After adjusting by population and publication rates Chile, Panama, Argentina, and Peru led registration rates per 1 million inhabitants. Variations in the number of trials per year are quite substantial. Clinical trial registration increased in a steady yet inconsistent way. The implementation of the Policy on Research for Health has been followed by an increase in countries that require registration and have established clinical trial registries. However, there is room for improvement in adherence throughout LAC. Trial registration is offered gratis by Brazilian, Cuban, Peruvian, and United States registries, among others.
这项描述性研究确定了2007年至2013年期间拉丁美洲和加勒比地区（LAC）在世界卫生组织国际临床试验注册平台（ICTRP）上的临床试验注册趋势，并提供了按人口和出版物计算的注册率调整估计值（2007年至2011年）。趋势和数据以互动图表的形式按次区域和语言呈现，包括按人口计算的年度注册率（2007年至2011年）以及在SCIENTI网络（科学和技术指标）中列出的出版物（LILACS和MEDLINE）。在涉及拉丁美洲和加勒比地区国家的11945项临床试验中，8282项在南美洲，其中巴西以4070项领先（占49%）；2421项在北美洲和中美洲，其中墨西哥以1886项领先（占78%）；1242项在加勒比地区，其中波多黎各以857项领先（占69%）。按人口和出版率调整后，智利、巴拿马、阿根廷和秘鲁的每百万居民注册率领先。每年试验数量的变化相当大。临床试验注册以稳定但不一致的方式增加。《健康研究政策》实施后，要求注册并建立临床试验注册机构的国家有所增加。然而，整个拉丁美洲和加勒比地区在遵守方面仍有改进空间。巴西、古巴、秘鲁和美国等国的注册机构提供免费的试验注册服务。
