ISPOR RWE SUMMIT POSTER 2025 | GinePro

Please find below a list of the key publications that were reviewed for the poster presentation, "A Review of the Challenges and Opportunities for the Use of Real-World Evidence for Medical Devices in Japan" (ISPOR RWE Summit, Tokyo, Japan, 28-30 September 2025).

Please contact us if you have any additional questions concerning the use of RWE for medical devices in Japan.

Bando H., Misumi T., Sakamoto Y., et al. (2024). Appropriate Relevancy and Reliability of Real-World Data for the Utilization of Regulatory Submission. Clin Colorectal Cancer, 23(2), 111–117.

Hayashi, K. (2017). リアルワールドデータの特徴とその利用 (Tips for Effectively Utilizing Real-World Data). レギュラトリーサイエンス学会誌 (Journal of the Japanese Society of Regulatory Science), 7(3), 197-203.

Hiramatsu K, Barrett A, Miyata Y. (2021). Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan. Drugs Real World Outcomes, 8(4):459-480.

Ishiguro C., Teshima Y., Nakamura H. (2025). Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products. J Pharm Policy Pract, 18(1), 2523935.

Ishii, K. (2021). 医療機器分野におけるRWDの活用 (Utilization of RWD in Medical Devices). 医薬品医療機器レギュラトリーサイエンス (Regulatory Science of Pharmaceuticals and Medical Devices), 52(5), 318-324.

Iwanaga, Y. (2022). わが国最大の循環器診療ビッグデータ，JROAD・JROAD-DPCデータベースの現状とその利活用 (The current state and utilization of JROAD and JROAD-DPC databases, Japan's largest big data for cardiovascular care). 循環器専門医 (Cardiovascular Specialist), 31(0), 55-62.

Kimura M, Watanabe H. (2022). Surveys Aimed at General Citizens of the US and Japan About Their Attitudes Toward Electronic Medical Data Handling - 10 Years Change, Before and After Covid-19. Stud Health Technol Inform, 300:135-148.

Kumamaru T., Kohsaka S., Tomotaki A., et al. (2016). 医療機器の市販後成績調査と症例レジストリの連携に向けたガイドライン案 (Guideline Proposal for Use of Clinical Registries in Collaboration with Post Marketing Surveillance for Medical Devices). 日本内科学会雑誌 (Journal of the Japanese Society of Internal Medicine), 105(11), 2183-2193.

LoPresti M, Igarashi A. (2024). A pragmatic review of cost-effectiveness evaluations of reimbursed medical devices conducted for Japan. J Med Econ, 27(1):1456-1471.

Maeda H, Ng DB. (2022). Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan. Front Med (Lausanne), 9:864960.

Matsushita S., Tachibana K., Kondoh M. (2019). The Clinical Innovation Network: a policy for promoting development of drugs and medical devices in Japan. Drug Discov Today, 24(1), 4–8.

Mitsubishi Research Institute. (2024). Investigation of utilization examples of real-world data (RWD) in medical device development (医療機器開発におけるリアルワールドデータ(RWD)の活用事例に関する調査).

Nagoshi K., Watari T., Matsumura Y. (2022). Prospects of Hospital Information Systems and Patient Safety in Japan. Healthc Inform Res., 28(2), 105–111.

Nariyuki S., Tanaka S., Hisayoshi A., et al. (2023). SaMDに対する医療データ利活用における業界側の期待と課題 (Industry Expectations and Challenges for SaMD in Utilizing Medical Data). レギュラトリーサイエンス学会誌 = Regulatory science of medical products, 13(3), 239-244.

Niwano S., Abe H., Takagi M., et al. (2020). Reassessment of practical usage and accumulation of real-world data of wearable cardioverter defibrillator (WCD) in Japan-Design paper for J-WCDR study. J Arrhythm, 37(1), 226–230.

Ota K., Tachibana K., Kusakabe T., et al. (2020). 市販後に性能が変わりうる医療機器のレギュラトリーサイエンス (A Regulatory Science for Medical Devices with Continuously Changing Properties in the Post-Marketing Phase). レギュラトリーサイエンス学会誌, 10(3), 131-137.

Sase, K. (2017). 医療機器におけるリアル・ワールド・エビデンスの活用 -戦略的レジストリ連携の現状と課題 - (Utilization of Real-World Evidence in Medical Devices - Current Status and Challenges of Strategic Registry Collaboration). 医療機器産業研究所スナップショット (Medical Device Industry Research Institute Snapshot), 16.

Tonegawa-Kuji R., Kanaoka K., Iwanaga, Y. (2023). Current status of real-world big data research in the cardiovascular field in Japan. J Cardiol., 81(3), 307–315.

Zhao Y, Tsubota T. (2023). The Current Status of Secondary Use of Claims, Electronic Medical Records, and Electronic Health Records in Epidemiology in Japan: Narrative Literature Review. JMIR Med Inform, 11:e39876.