Medical Affairs, Bayer S.A, Bogotá, Colombia.
Epidemiology, Bayer Hispania, Barcelona, Spain.
Pharmacol Res Perspect. 2020 Oct;8(5):e00661. doi: 10.1002/prp2.661.
Real-world evidence (RWE) is emerging as a fundamental component of the post-marketing evaluation of medicinal products. Even though the focus on RWE studies has increased in Colombia, the availability of secondary data sources to perform this type of research is not well documented. Thus, we aimed at identifying and characterizing secondary data sources available in Colombia. We performed a systematic literature review on PubMed, EMBASE, and VHL using a combination of controlled vocabulary and keywords for the concepts of electronic health records, epidemiologic studies and Colombia. A total of 323 publications were included. These comprised 123 identified secondary data sources including pharmacy dispensing databases, government datasets, disease registries, insurance databases, and electronic heath records, among others. These data sources were mostly used for cross-sectional studies focused on disease epidemiology in a specific population. Almost all databases (95%) contained demographic information, followed by pharmacological treatment (44%) and diagnostic tests (39%). Even though the database owner was identifiable in 94%, access information was only available in 44% of the articles. Only a pharmacy-dispensing database, local cancer registries, and government databases included a description regarding the quality of the information available. The diversity of databases identified shows that Colombia has a high potential to continue enhancing its RWE strategy. Greater efforts are required to improve data quality and accessibility. The linkage between databases will expand data pooling and integration to boost the translational potential of RWE.
真实世界证据(RWE)正在成为药品上市后评估的一个基本组成部分。尽管哥伦比亚对 RWE 研究的关注有所增加,但用于进行此类研究的二次数据来源的可用性并未得到很好的记录。因此,我们旨在确定和描述哥伦比亚可用的二次数据来源。我们在 PubMed、EMBASE 和 VHL 上进行了系统的文献回顾,使用了电子健康记录、流行病学研究和哥伦比亚这三个概念的受控词汇和关键词的组合。共纳入了 323 篇出版物。其中包括 123 个已确定的二次数据源,包括药房配药数据库、政府数据集、疾病登记处、保险数据库和电子健康记录等。这些数据源主要用于针对特定人群疾病流行病学的横断面研究。几乎所有数据库(95%)都包含人口统计学信息,其次是药物治疗(44%)和诊断测试(39%)。尽管 94%的文章都可以识别数据库所有者,但只有 44%的文章提供了访问信息。只有一个药房配药数据库、当地癌症登记处和政府数据库包含有关可用信息质量的说明。所确定的数据库的多样性表明,哥伦比亚有很大的潜力继续加强其 RWE 战略。需要做出更大的努力来提高数据质量和可及性。数据库之间的联系将扩大数据池化和整合,以提高 RWE 的转化潜力。