Real World Data Use in Pharmaceutical Companies in Japan： Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association

Ryo Koto; Shinichi Asabe; Akira Ito; Kasumi Daidoji; Manabu Ishii; Kanae Togo; Hiroshi Matsuzawa

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Real World Data Use in Pharmaceutical Companies in Japan： Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association

VernacularTitle:製薬企業におけるリアルワールドデータの本邦での利活用に関する現状及び課題―日本製薬工業協会医薬品評価委員会臨床評価部会加盟各社に対するアンケート調査―
Author: Ryo KOTO ¹ ; Shinichi ASABE ² ; Akira ITO ¹ ; Kasumi DAIDOJI ³ ; Manabu ISHII ¹ ; Kanae TOGO ⁴ ; Hiroshi MATSUZAWA ¹
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1. Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Japan
2. AstraZeneca K.K., Japan
3. AbbVie GK, Japan
4. DAIICHI SANKYO COMPANY, LIMITED, Japan
Keywords: drug development; health service research; real-world data; real-world evidence; surveys and questionnaire
From:Japanese Journal of Pharmacoepidemiology 2024;29(1):15-28
CountryJapan
Language:Japanese
Abstract: Objective：To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design：Web based-questionnaire surveyMethods：This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results：［Background］ Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5％) have “experienced in utilization of RWD”, and 12 (11.8％) have “experienced in considering utilization of RWD”. ［Utilization by RWD Type］ By data source, hospital-based claim data was the most frequently used (65 cases, 63.7％), followed by insurance-based claim data (61 cases, 59.8％), surveys (38 cases, 37.3％), and EMR (36 cases, 35.3％) in experienced RWD utilization. Conclusion：This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.