Faculty of Pharmaceutical Sciences, State University of Campinas, Campinas, São Paulo, Brazil.
J Evid Based Med. 2020 Nov;13(4):261-264. doi: 10.1111/jebm.12415. Epub 2020 Nov 3.
Evidence-based medicine uses high-quality methods, such as randomization and blinding prcedures, to support and inform clinical practice. The investigation of trials registered in clinical research databases may help understand the main characteristics of studies conducted in countries, such as Brazil. This study aimed to investigate the characteristics of Brazilian clinical trials registered in ClinicalTrials.gov in the last decade.
Cross-sectional study performed in ClinicalTrials.gov database with clinical studies registered in Brazil between 2010 and 2020. A search was conducted in the database considering this period using filters for country (Brazil), start date (01 January 2010) and end date (date of the search: 07 May 2020). Descriptive statistics were used to characterize the studies. All analyses were conducted on Stata 14.2.
In total, 5368 studies were retrieved, which were mostly randomized (93.2%), blinded (63.2%), Phase III (48.7%) interventional studies (89.9%) with small sample sizes (57.2%) conducted with adults (93.0%) using drugs (42.7%) with a treatment purpose (77.3%), with funding from institutions other than the industry, the NIH, and the US Federal (71.3%).
The majority of Brazilian clinical studies used blinding and randomization procedures in the last 10 years. However, the predominance of trials with small sample sizes and with a focus on adult patients indicate the need of larger studies conducted with the pediatric population.
循证医学使用高质量的方法，如随机化和盲法程序，来支持和指导临床实践。对临床研究数据库中注册的试验的研究可能有助于了解巴西等国家开展的研究的主要特征。本研究旨在调查过去十年在 ClinicalTrials.gov 中注册的巴西临床研究的特征。
在 ClinicalTrials.gov 数据库中进行了一项横断面研究，纳入了 2010 年至 2020 年在巴西开展的临床研究。使用国家（巴西）、开始日期（2010 年 1 月 1 日）和结束日期（检索日期：2020 年 5 月 7 日）的过滤器在数据库中进行检索。采用描述性统计对研究进行特征描述。所有分析均在 Stata 14.2 上进行。
共检索到 5368 项研究，其中大多数为随机对照试验（93.2%）、盲法（63.2%）、III 期（48.7%）干预性研究（89.9%），样本量较小（57.2%），主要针对成年人（93.0%），使用药物（42.7%），以治疗为目的（77.3%），资金来源于除工业界、NIH 和美国联邦以外的机构。
在过去的 10 年中，巴西的大多数临床研究都使用了盲法和随机化程序。然而，试验样本量较小且主要针对成年患者的情况表明，需要开展更多针对儿科人群的大型研究。
