The increasing volume and complexity of data now being captured across multiple settings and devices offers the opportunity to deliver a better characterization of diseases, treatments, and the performance of medicinal products in individual healthcare systems. Such data sources, commonly labeled as big data, are generally large, accumulating rapidly, and incorporate multiple data types and forms. Determining the acceptability of these data to support regulatory decisions demands an understanding of data provenance and quality in addition to confirming the validity of new approaches and methods for processing and analyzing these data. The Heads of Agencies and the European Medicines Agency Joint Big Data Taskforce was established to consider these issues from the regulatory perspective. This review reflects the thinking from its first phase and describes the big data landscape from a regulatory perspective and the challenges to be addressed in order that regulators can know when and how to have confidence in the evidence generated from big datasets.

中文翻译：

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大数据-如何实现承诺。

现在，跨多种设置和设备捕获的数据量越来越大，越来越复杂，这为在单个医疗保健系统中更好地表征疾病，治疗方法和药品性能提供了机会。通常被标记为大数据的此类数据源通常很大，并且积累迅速，并包含多种数据类型和形式。确定这些数据的可接受性以支持监管决策不仅需要确认处理和分析这些数据的新方法和方法的有效性，还需要了解数据的来源和质量。机构负责人和欧洲药品管理局联合大数据工作组的成立是为了从监管角度考虑这些问题。