A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan

Our two-week pilot indicates that ePRO can achieve data completeness comparable to paper in motivated clinics. The points to consider when using ePRO in actual PMS were confirmed. Further assessment in actual studies conducted in compliance with local regulations is needed.

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Publication Details

Journal
Therapeutic Innovation & Regulatory Science
Published
2025-09-24
DOI
https://doi.org/10.1007/s43441-025-00873-0
Primary Topic
Digital Mental Health Interventions
Type
article
Field-Weighted Citation Impact
0.00

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article

A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan

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Therapeutic Innovation & Regulatory Science
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article

A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan

Nobushige Matsuoka, Tetsuya Hiraiwa, Akira Hoshino, Hidetoshi Misawa, Natsuno Yamashita, Yoko Sato, Hiromi Yamaguchi, N. Sugimoto, M. Kawai, Mika Morimasa
article en

Abstract

Our two-week pilot indicates that ePRO can achieve data completeness comparable to paper in motivated clinics. The points to consider when using ePRO in actual PMS were confirmed. Further assessment in actual studies conducted in compliance with local regulations is needed.

Therapeutic Innovation & Regulatory ScienceVol. 60(1)
Pfizer (Japan) (JP)
Pfizer
Openalex Percentile: Top 71%
Digital Mental Health Interventions
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