Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil.
Am Heart J. 2013 Jun;165(6):848-53. doi: 10.1016/j.ahj.2013.02.004. Epub 2013 Mar 25.
In recent years, international clinical trials have increasingly included large numbers of patients and research sites from developing countries. In South America particularly, enrollment in randomized clinical trials has increased substantially. Despite this significant growth of late, there has been little systematic assessment of the role of this region in cardiovascular clinical trials. South America has several strengths with respect to conducting and participating in clinical trials. These include a large population, a high prevalence of cardiovascular diseases, reliable quality of data, a track record of important contributions to previous clinical trials, and good patient adherence and retention in trials. Labor costs also tend to be lower than those in high-income countries. On the other hand, clinical research in this region of the world faces limitations posed by a relatively small clinical trials network with limited operations expertise, as well as prolonged regulatory approval timelines, diversity in health care systems, limited training opportunities in clinical research, and a low patient level of education. Thus, there are many opportunities to improve the conduct of clinical research in South America, but strategies and systems must be developed to overcome barriers in this economically growing region and to establish a robust infrastructure for clinical trials, including high-quality investigator networks.
近年来，国际临床试验越来越多地纳入了来自发展中国家的大量患者和研究基地。特别是在南美洲，随机临床试验的入组人数大幅增加。尽管最近有了显著的增长，但对该地区在心血管临床试验中的作用的系统评估却很少。
就开展和参与临床试验而言，南美洲有几个优势。这些优势包括人口众多、心血管疾病高发、数据质量可靠、在以往临床试验中做出重要贡献的记录，以及患者在试验中的良好依从性和保留率。劳动力成本也往往低于高收入国家。
另一方面，该地区的临床研究面临着一些限制，包括相对较小的临床试验网络，运营专业知识有限，以及监管审批时间延长、医疗保健系统多样化、临床研究培训机会有限、患者教育水平低等。
因此，南美洲有很多机会可以改善临床研究的开展，但必须制定战略和系统来克服这个经济增长地区的障碍，并为临床试验建立一个强大的基础设施，包括高质量的研究人员网络。
