Development of ePRO System in Investigator Sponsored Clnical Research

Research Project

Project/Area Number	18K14976
Research Category	Grant-in-Aid for Early-Career Scientists
Allocation Type	Multi-year Fund
Review Section	Basic Section 47060:Clinical pharmacy-related
Research Institution	Tohoku University
Principal Investigator	TAKATA MUNENORI 東北大学, 大学病院, 特任講師 (70746841)
Project Period (FY)	2018-04-01 – 2022-03-31
Project Status	Completed (Fiscal Year 2021)
Budget Amount *help	¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000) Fiscal Year 2021: ¥520,000 (Direct Cost: ¥400,000、Indirect Cost: ¥120,000) Fiscal Year 2020: ¥520,000 (Direct Cost: ¥400,000、Indirect Cost: ¥120,000) Fiscal Year 2019: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000) Fiscal Year 2018: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
Keywords	患者報告型アウトカムデータ / ePRO / CSV / 医師主導型臨床研究 / 患者報告アウトカム / 臨床研究 / コンピュータシステムバリデーション / 医師主導臨床研究 / 電磁的データ収集
Outline of Final Research Achievements	Through industry-academia collaborations conducted with system vendors, ePRO systems were implemented in 26 Investigator-initiated clinical trials, 24 observational studies, 14 interventional studies, 8 randomized controlled trials, and 5 registry studies. By disease area, 17 studies in psychiatry, where subjects' subjective data are particularly important, five in breast surgery, three in hematology, two in women's surgery, oncology, pediatrics, and urology have been completed, implemented, or continued utilizing ePRO data. In this study, the development of documentation related to CSV and Software Development Lifecycle led to an increase in the utilized of ePRO in investigator-initiated clinical research.
Academic Significance and Societal Importance of the Research Achievements	日本国内の研究者主導型臨床研究におけるePRO活用の普及に資するとともに、データ収集方法の効率化にもつながることとなった。また、臨床研究への患者参画の意味や、昨今のCOVID19感染拡大に伴う、Decentralized Clinical Trialの普及についても、本研究におけるePRO開発が果たした社会的意義は大きい。また、臨床研究に留まらず、臨床現場でのePROの活用について新たな課題を見出し、今後、後継のプロジェクトにおいて課題解決を図る予定である。