Ito Satoru, Narukawa Mamoru
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.
Kyowa Kirin Co., Ltd., Tokyo, Japan.
Ther Innov Regul Sci. 2025 Mar;59(2):288-294. doi: 10.1007/s43441-024-00729-z. Epub 2024 Dec 21.
One of the main objectives of pharmacovigilance activities is to confirm unknown adverse drug reactions (ADRs), and data-mining methods have been developed to detect signals that are candidates for ADRs. Reference sets have been developed to evaluate the performance of the data-mining methods. However, reference sets generated in previous studies are not based on Japanese safety information; therefore, they are not suitable for use in evaluation studies in Japan because some drugs have not been approved or marketed for a long time in Japan. This study aimed to develop a reference set using drug safety information marketed in Japan and to evaluate its performance.
A reference set was developed for 43 drugs and 15 events. For each combination of the selected drug and event, those that were listed as important identified risks in the Japan Risk Management Plan (J-RMP) were set as "positive controls" and those that were not listed as adverse reactions in the package insert were set as "negative controls." In addition, we performed data-mining using Japanese Adverse Drug Event Report database (JADER) and evaluated the results against the reference set to empirically confirm its effectiveness.
The reference set included 127 positive and 386 negative controls. A comparison of the signals obtained from data-mining using JADER with the reference set revealed higher correlations than those in previous studies.
A reference set was developed using the safety information of drugs approved in Japan to promote research on data-mining methods.
药物警戒活动的主要目标之一是确认未知的药物不良反应（ADR），并且已经开发了数据挖掘方法来检测可能是ADR的信号。已经开发了参考集来评估数据挖掘方法的性能。然而，先前研究中生成的参考集并非基于日本的安全信息；因此，它们不适用于日本的评估研究，因为一些药物在日本未获批或上市很长时间。本研究旨在利用日本市场上的药物安全信息开发一个参考集并评估其性能。
为43种药物和15种事件开发了一个参考集。对于所选药物和事件的每种组合，在日本风险管理计划（J-RMP）中列为重要识别风险的那些被设为“阳性对照”，而在药品说明书中未列为不良反应的那些被设为“阴性对照”。此外，我们使用日本药品不良事件报告数据库（JADER）进行数据挖掘，并根据参考集评估结果以实证确认其有效性。
该参考集包括127个阳性对照和386个阴性对照。将使用JADER进行数据挖掘获得的信号与参考集进行比较，结果显示相关性高于先前研究。
利用在日本获批药物的安全信息开发了一个参考集，以促进数据挖掘方法的研究。
