Development of ePRO System in Investigator Sponsored Clnical Research

2021 Fiscal Year Final Research Report

• 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
• 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

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.

Free Research Field

臨床データマネジメント

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。