Santana Rafael Santos, Leite Silvana Nair
Universidade de Brasília, Faculdade de Saúde, Brasília (DF), Brasil.
Universidade Federal de Santa Catarina, Departamento de Ciências Farmacêuticas, Florianópolis (SC), Brasil.
Rev Panam Salud Publica. 2016 Nov;40(5):356-362.
To identify clinical drug trials performed in Brazil between 2012 and 2015, with emphasis on those focusing on neglected diseases of poverty.
Two clinical trial registries, ReBEC (Brazilian registry) and ClinicalTrials.gov were surveyed. The following aspects were investigated: distribution of clinical trials in relation to the burden of disease in Brazil, distribution of trials regarding their focus on diseases of poverty vs. diseases not linked to poverty, phase of trials, performing institution, and type of funding (private, public, or mixed).
The search revealed 866 eligible trials, 88 registered in ReBEC and 778 in ClinicalTrials.gov. Of these, 73 (8.5%) were phase I trials, 610 (70.5%) were phase II and III trials, and 183 (21%) were phase IV trials. There were 38 trials (4%) focusing on neglected diseases of poverty. Regarding the burden of disease, 734 (84.8%) trials focused on noncommunicable diseases, which in fact represent the largest burden of disease in Brazil. Most trials were carried out by pharmaceutical companies (55.3%), with predominance of private funding (57.1%); however, if only the diseases of poverty are considered, 63.1% were financed by public resources.
The clinical drug trials carried out in Brazil in the study period are in agreement with the proportional burden of disease for the country. However, the neglected diseases of poverty were not prioritized. More effective action is necessary to redirect clinical research on drug development to meet national needs.
识别2012年至2015年期间在巴西开展的临床药物试验，重点关注那些针对贫困相关被忽视疾病的试验。
对两个临床试验注册库，即巴西临床试验注册库（ReBEC）和美国国立医学图书馆临床试验数据库（ClinicalTrials.gov）进行了调查。调查了以下几个方面：巴西临床试验在疾病负担方面的分布情况、试验在关注贫困相关疾病与非贫困相关疾病方面的分布情况、试验阶段、执行机构以及资金类型（私人、公共或混合）。
检索发现866项符合条件的试验，其中88项在ReBEC注册，778项在ClinicalTrials.gov注册。其中，73项（8.5%）为I期试验，610项（70.5%）为II期和III期试验，183项（21%）为IV期试验。有38项（4%）试验关注贫困相关被忽视疾病。关于疾病负担，734项（84.8%）试验关注非传染性疾病，而事实上非传染性疾病是巴西最大的疾病负担。大多数试验由制药公司开展（55.3%），资金主要来自私人（57.1%）；然而，若仅考虑贫困相关疾病，63.1%由公共资源资助。
研究期间在巴西开展的临床药物试验与该国疾病负担比例相符。然而，贫困相关被忽视疾病未被列为优先事项。有必要采取更有效的行动，将药物研发的临床研究重新导向以满足国家需求。
