A new electronic medical record database linked to claims data and discharge abstract data (the RWD database) in Japan: Study design and profile-Reference-Cited by-同舟云学术

A new electronic medical record database linked to claims data and discharge abstract data (the RWD database) in Japan: Study design and profile

Published:2024 Issue:3 Volume:6 Page:58-64
ISSN:2434-4338
Container-title:Annals of Clinical Epidemiology
language:en
Short-container-title:ACE

Author:

Okumura Yasuyuki¹²,Fujiwara Takashi³,Tokumasu Hironobu⁴,Kimura Takeshi¹,Hinotsu Shiro⁵⁶

Affiliation:

1. Real World Data Co., Ltd.

2. Initiative for Clinical Epidemiological Research

3. Department of Otolaryngology, Kurashiki Central Hospital

4. Department of Management, Clinical Research Center, Kurashiki Central Hospital

5. Health, Clinic, and Education Information Evaluation Institute (HCEI)

6. Biostatistics and Data Management, Sapporo Medical University

Publisher

Society for Clinical Epidemiology

Link

https://www.jstage.jst.go.jp/article/ace/6/3/6_24009/_pdf

Reference22 articles.

1. 1. US Food and Drug Administration. Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics: guidance for industry. https://www.fda.gov/media/124795/download. Accessed 2024 April 1.

2. 2. Ministry of Health, Labour and Welfare. Revised GPSP Ordinance (in Japanese). https://www.pmda.go.jp/files/000220766.pdf. Accessed 2024 April 1.

3. 3. Corrigan-Curay J, Sacks L,Woodcock J. Real-world evidence and real-world data for evaluating drug safety and effectiveness. JAMA 2018;320:867–868.

4. 4. Jarow JP, LaVange L,Woodcock J. Multidimensional evidence generation and FDA regulatory decision making: defining and using “Real-World” data. JAMA 2017;318:703–704.

5. 5. Suto M, Iba A, Sugiyama T, Kodama T, Takegami M, Taguchi R, et al. Literature Review of Studies Using the National Database of the Health Insurance Claims of Japan (NDB): Limitations and Strategies in Using the NDB for Research. JMA J 2024;7:10–20.