Univ. Bordeaux, INSERM, BPH, U1219, Bordeaux, F-33000, France.
MSD France, Puteaux, F-92800, France.
Fundam Clin Pharmacol. 2021 Feb;35(1):76-85. doi: 10.1111/fcp.12592. Epub 2020 Aug 17.
Considering their novelty and cost, post-marketing evaluation is highly relevant for new anticancer drugs. Identify and characterize available and potentially useful databases for post-marketing evaluation of these specific drugs is necessary. A review was conducted to identify available and accessible databases to study the post-marketing evaluation of drugs in real-life care setting. Databases identified have been classified into medico-administrative databases, medical record databases, and databases resulting from ad hoc collections. Taking as examples databases available in France, each type was described as well as its strengths and limits for a potential use in the oncology field. Record linkage of medico-administrative databases could cover almost the whole population and is now used to evaluate anticancer drugs (e.g., Système National des Données de Santé). Large medical record databases are still lacking, but efforts are currently made to give access to hospital data warehouses for research purposes. Finally, databases resulting from ad hoc collections are also available for some cancer localizations and allow to obtain highly valuable clinical and biological data. A range of important and valuable databases exist but, individually, none is enough to answer to all questions from health authorities, healthcare professionals, and patients. In order to obtain a complete overview on utilization, associated health outcomes and costs of these drugs, it seems necessary to better interlink available databases.
考虑到其新颖性和成本，新的抗癌药物的上市后评估非常重要。有必要确定和描述可用于这些特定药物上市后评估的现有和潜在有用的数据库。进行了一项审查，以确定可用于在真实护理环境中研究药物上市后评估的现有和可访问的数据库。已将确定的数据库分为医疗管理数据库、病历数据库和特别收集产生的数据库。以法国可用的数据库为例，描述了每种类型及其在肿瘤学领域潜在用途的优势和局限性。医疗管理数据库的记录链接几乎可以涵盖整个人口，现在用于评估抗癌药物（例如，国家健康数据系统）。目前仍缺乏大型病历数据库，但正在努力为研究目的提供访问医院数据仓库的权限。最后，一些癌症定位也可以使用特别收集产生的数据库，从而获得非常有价值的临床和生物学数据。存在一系列重要和有价值的数据库，但单独使用任何一个数据库都不足以回答来自卫生当局、医疗保健专业人员和患者的所有问题。为了全面了解这些药物的使用情况、相关的健康结果和成本，似乎有必要更好地将现有数据库相互关联。
