Yamazaki Hiroshi, Nakajo Ko, Hirose Naoki, Yan Li, Lee Sun Yeop, Zhang Yongjing, Qiu Hong, Ishiguro Chieko
Global Epidemiology, Johnson & Johnson, Tokyo, Japan.
Global Epidemiology, Johnson & Johnson, Beijing, China.
Front Pharmacol. 2025 Jul 21;16:1565314. doi: 10.3389/fphar.2025.1565314. eCollection 2025.
To investigate the characteristics of post-marketing database studies (PMDS) included in risk management plans (RMPs) across all therapeutic areas in Japan.
Two researchers systematically and independently reviewed all RMPs listed on the Pharmaceuticals and Medical Devices Agency website from April 2013 to December 2023. PMDS contained in RMPs were identified, reviewed, and summarized by study design, target objectives, and data source. Specific objectives were linked to the data source.
Among 648 RMPs retrieved/reviewed, 85 PMDS were identified from 63 RMPs targeting 138 safety and five effectiveness objectives. Among 85 PMDS, 57 (67.1%) PMDS targeted important identified risk and 29 (34.1%) targeted important potential risk. Cohort studies were the most prevalent study design (74/85, 87.1%), and 74.1% (63/85) included a comparator group. Common target safety objectives included "infections and infestations", "metabolism and nutrition disorders", "cardiac disorders" and "vascular disorders". The Medical Data Vision database was the most frequently used data source for PMDS (32/85, 37.5%) followed by the Medical Information Database Network (MID-NET) (18/85, 21.2%) and JMDC (9/85, 10.6%).
In Japan, PMDS are usually cohort studies with targeted safety objectives. Most studies currently target important identified risk rather than important potential risk and may not make full use of the advantages of PMDS that can include large populations, comparator groups, and that can assess the occurrence of rare adverse events. These results could be informative for pharmaceutical companies planning post-marketing studies as pharmacovigilance activities. Early public availability of PMDS protocols would promote improved study methodology and could potentially improve the scientific value of PMDS in Japan.
调查日本所有治疗领域风险管理计划（RMP）中包含的上市后数据库研究（PMDS）的特征。
两名研究人员系统地、独立地审查了2013年4月至2023年12月在药品和医疗器械局网站上列出的所有RMP。对RMP中包含的PMDS进行识别、审查，并按研究设计、目标和数据源进行总结。具体目标与数据源相关联。
在检索/审查的648个RMP中，从针对138个安全性目标和5个有效性目标的63个RMP中识别出85个PMDS。在85个PMDS中，57个（67.1%）PMDS针对已识别的重要风险，29个（34.1%）针对重要潜在风险。队列研究是最常见的研究设计（74/85，87.1%），74.1%（63/85）包括一个对照组。常见的目标安全性目标包括“感染和寄生虫感染”、“代谢和营养紊乱”、“心脏疾病”和“血管疾病”。医学数据视觉数据库是PMDS最常用的数据源（32/85，37.5%），其次是医学信息数据库网络（MID-NET）（18/85，21.2%）和JMDC（9/85，10.6%）。
在日本，PMDS通常是针对安全性目标的队列研究。目前大多数研究针对已识别的重要风险而非重要潜在风险，可能未充分利用PMDS可纳入大量人群、对照组并可评估罕见不良事件发生情况的优势。这些结果可能为计划开展上市后研究作为药物警戒活动的制药公司提供信息。PMDS方案的早期公开可用性将促进研究方法的改进，并有可能提高日本PMDS 的科学价值。
