Macías Saint-Gerons Diego, de la Fuente Honrubia César, de Andrés Trelles Fernando, Catalá-López Ferrán Catalá-López
División de Farmacoepidemiología y Farmacovigilancia. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Madrid.
Área de Estabilidad Presupuestaria. Subdirección General de Análisis Presupuestario y Organización Institucional del Sector Público Autonómico. Secretaría General de Coordinación Autonómica y Local. Ministerio de Hacienda y Administraciones Públicas. Madrid. España.
Rev Esp Salud Publica. 2016 Dec 1;90:e1-e7.
The arrival of new drug into the market requires many years of previous research along with the need of continuous evaluation throughout the lifetime of the drug. This warrants pharmacoepidemiological research which may be defined as the study of the use and the effects of drugs in large populations. Nowadays this type of research seems more feasible thanks to the massive expansion of the information sources and data (e.g: clinical patient registries, electronic medical records). However there is a risk of information overload, fragmented evidence and given the enthusiasm aroused by the "Big Data", it must be emphasized that its nature is mainly observational, and therefore subject to bias and confusion. The application of epidemiological methods in this scenario seems essential for any analysis. In short, the management and use of these data sources to generate useful information expansion is the next challenge for the application of research methods in modern pharmacoepidemiology.
新药进入市场需要多年的前期研究，并且在药物的整个生命周期内都需要持续评估。这就需要进行药物流行病学研究，药物流行病学研究可定义为对大量人群中药物的使用及其效果的研究。如今，由于信息来源和数据的大量扩充（例如临床患者登记、电子病历），这类研究似乎更可行。然而，存在信息过载、证据零散的风险，并且鉴于“大数据”引发的热情，必须强调其本质主要是观察性的，因此容易出现偏差和混淆。在这种情况下，应用流行病学方法对于任何分析似乎都是必不可少的。简而言之，管理和利用这些数据源以生成有用的信息扩展，是现代药物流行病学研究方法应用的下一个挑战。
