Re-engineering a Clinical Trial Management System Using Blockchain Technology: System Design, Development, and Case Studies

作者：Yan Zhuang, Luxia Zhang, Xiyuan Gao, Zon‐Yin Shae, Jeffrey J. P. Tsai, Pengfei Li, Chi‐Ren Shyu · 发表于：Journal of Medical Internet Research · 年份：2022 · DOI：10.2196/36774 · 被引用次数：30 · 研究领域：Blockchain Technology Applications and Security、Ethics in Clinical Research、Big Data and Digital Economy

BACKGROUND: A clinical trial management system (CTMS) is a suite of specialized productivity tools that manage clinical trial processes from study planning to closeout. Using CTMSs has shown remarkable benefits in delivering efficient, auditable, and visualizable clinical trials. However, the current CTMS market is fragmented, and most CTMSs fail to meet expectations because of their inability to support key functions, such as inconsistencies in data captured across multiple sites. Blockchain technology, an emerging distributed ledger technology, is considered to potentially provide a holistic solution to current CTMS challenges by using its unique features, such as transparency, traceability, immutability, and security. OBJECTIVE: This study aimed to re-engineer the traditional CTMS by leveraging the unique properties of blockchain technology to create a secure, auditable, efficient, and generalizable CTMS. METHODS: A comprehensive, blockchain-based CTMS that spans all stages of clinical trials, including a sharable trial master file system; a fast recruitment and simplified enrollment system; a timely, secure, and consistent electronic data capture system; a reproducible data analytics system; and an efficient, traceable payment and reimbursement system, was designed and implemented using the Quorum blockchain. Compared with traditional blockchain technologies, such as Ethereum, Quorum blockchain offers higher transaction throughput and lowers transaction latency. Case stud...