BRIEF RESEARCH REPORT article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1642490
This article is part of the Research TopicAdvancement of RWD/RWE Utilization for Enhancing Drug Development and Benefit/Risk AssessmentView all 4 articles
Trends in the Use of Validated Claims-Based Algorithms in Japanese Post-Marketing Database Studies
Provisionally accepted
- 1Kokuritsu Kenko Kiki Kanri Kenkyu Kiko, Shinjuku, Japan
- 2Tokyo Daigaku, Bunkyo, Japan
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Background: In pharmacoepidemiological research, misclassification is a concern with claims-based algorithms (also called computable phenotypes). Validating them is crucial, particularly within regulatory settings. However, the extent of their application remains unclear globally. Objectives: This study aimed to investigate the frequency and trends of validated claims-based algorithms use in post-marketing database studies. Method: We reviewed all Japanese risk management plans published until January 2023, identifying four issue types [Effectiveness Issues (EI), Important Identified Risks (IIR), Important Potential Risks (IPR), and Important Missing Information (IMI)] that were planned to use a claims-based algorithm in post-marketing database studies. We then calculated the proportion of issues intending to use a validated claims-based algorithm, and performed subgroup analyses by issue type. Results: Of 68 issues (3 EI, 47 IIR, 13 IPR, 5 IMI), 15 (22.1%) planned to use a validated algorithm, all for outcome definitions; 10 to conduct new validation studies and 5 to refer to existing studies, including studies with high positive predictive value and sensitivity. Subgroup analyses by issue type showed that the proportions were 100% for EI, 17.0% for IIR, 30.8% for IPR, and 0% for IMI. Conclusion: Validated algorithm use was the highest for effectiveness issues but limited for safety, suggesting that results from these post-marketing database studies for safety issues may not provide sufficient evidence, highlighting the need to promote the use of validated claims-based algorithms. Future studies should use more recent data, compare the use of validated algorithms between Japan and other countries, and explore barriers to their adoption.
Keywords: Real world evidence, validity, claims-based algorithm, database, Post-marketing study, regulatoryframeworks, Risk management plan, Pharmacovigilance
Received: 06 Jun 2025; Accepted: 14 Aug 2025.
Copyright: © 2025 Ishiguro and Nonaka. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Chieko Ishiguro, Kokuritsu Kenko Kiki Kanri Kenkyu Kiko, Shinjuku, Japan
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.