Journal of the Japan Society of Clinical Trials and Research
Online ISSN : 2759-7601
Original Article
“A Survey of the Current Status and Challenges Faced by Clinical Trial Sites in Fair Market Value-derived Task-Based Cost Estimation”
Naoki KondoYusuke FukudaKeiichi InaizumiTatsuya WatanabeShota HiguchiTakeshi IoroiMasahiko OzakiTakuhiro YamaguchiMasayoshi KoinumaSatoshi Kuroda
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JOURNAL FREE ACCESS

2026 Volume 31 Pages 14-27

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Abstract

Background Despite the international recognition of task‑based cost estimation using the Fair Market Value, its implementation in Japan remains limited, and its benefits and challenges remain mostly unelucidated. This study aimed to clarify the implementation status, advantages, and challenges of task‑based cost estimation using Fair Market Value in Japanese medical institutions.

Methods A questionnaire survey was conducted in 154 institutions that had experience with this ap-proach, and a total of 63 institutions (33 clinics and 30 hospitals) were included in the analysis.

Results The results indicated that task‑based cost estimation based on the Fair Market Value had been introduced primarily as a test case. The most common trigger for its implementation was a request from sponsors. Although improved transparency and greater acceptability were an-ticipated as potential benefits, the most frequent response in the survey was that the effects remained unclear due to the recent introduction of the system. The most commonly cited challenge was the increase in operational burden. Additional issues included the need for cost‑sharing adjustments with Site Management Organizations, concerns regarding revenue reduction, and cost allocation among internal departments. Furthermore, in clinics, difficulties in negotiations with sponsors were reported.

Conclusion The widespread adoption of task‑based cost estimation using the Fair Market Value would require substantial contributions from sponsors; however, it is crucial that medical institutions take an active, independent role in developing the requisite institutional infrastructure.

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© 2026 Japan Society of Clinical Trials and Research
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