Survey on the Development of Companion Apps for Pharmaceuticals and Data Utilization

Tempei Miyaji; Hideki OI; Kenji Hatano; Satoshi Ueno; Takuhiro Yamaguchi; Harumasa Nakamura

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Survey on the Development of Companion Apps for Pharmaceuticals and Data Utilization

VernacularTitle:医薬品のコンパニオンアプリの開発とデータ利活用に関する実態調査
Author: Tempei MIYAJI ¹ ; Hideki OI ¹ ; Kenji HATANO ¹ ; Satoshi UENO ² ; Takuhiro YAMAGUCHI ³ ; Harumasa NAKAMURA ⁴
Author Information

1. Department of Clinical Data Science, Clinical Research and Education Promotion Division, National Center of Neurology and Psychiatry, Japan
2. Center for Health Informatics Policy, National Institute of Public Health, Japan
3. Division of Biostatistics, Tohoku University Graduate School of Medicine, Japan
4. Department of Clinical Research Support, Clinical Research & Education Promotion Division, National Center of Neurology and Psychiatry, Japan
Keywords: companion app; patient-reported outcome; real-world data; regulatory science
From:Japanese Journal of Pharmacoepidemiology 2024;():29.e4-
CountryJapan
Language:Japanese
Abstract: This document reports the results of a questionnaire survey conducted among pharmaceutical companies that are members of the Japan Pharmaceutical Manufacturers Association as part of a collaborative research project within the AMED Research on Regulatory Science of Pharmaceuticals and Medical Devices ‘Research for the promotion of the utilization of real-world evidence in the pharmaceutical regulatory system and the harmonization of international regulations, and for the proposal of an ideal system in Japan’ (Principal Investigator： Harumasa Nakamura, National Center of Neurology and Psychiatry). This survey is the first domestic attempt to clarify the current state of development and utilization of data for companion applications (CPs) in pharmaceuticals. It is expected that the widespread development and use of pharmaceutical CPs will enhance the collection of patient-reported outcomes (PROs), which in turn will foster the utilization of real-world data (RWD) under pharmaceutical regulations. In anticipation that the results of this survey will contribute to this promotion, we are publishing the entire questionnaire results in this report.