开发一个欧洲联盟时间索引参考数据集,用于使用大语言模型评估药典信号检测方法的性能

Development of a European Union Time-Indexed Reference Dataset for Assessing the Performance of Signal Detection Methods in Pharmacovigilance using a Large Language Model

Background: The identification of optimal signal detection methods is hindered by the lack of reliable reference datasets. Existing datasets do not capture when adverse events (AEs) are officially recognized by regulatory authorities, preventing restriction of analyses to pre-confirmation periods and limiting evaluation of early detection performance. This study addresses this gap by developing a time-indexed reference dataset for the European Union (EU), incorporating the timing of AE inclusion