Re-Engineering Clinical Trial Management System Using Blockchain Technology: System Design, Development, and Case Studies (Preprint)

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 CTMS 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 the expectations due to 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 the current CTMS challenges by utilizing its unique features such as transparency, traceability, immutability, and security. OBJECTIVE This study aimed at re-engineering the traditional CTMS by leveraging the unique properties of Blockchain technology to create a secured, auditable, efficient, and generalizable CTMS. METHODS A comprehensive, blockchain-based CTMS that spans all stages of clinical trials, including (1) a sharable Trial Master File system, (2) a fast Recruitment and simplified Enrollment system, (3) a timely, secured, and consistent Electronic Data Capture system, (4) a reproducible Data Analytics System and (5) an Efficient, Traceable Payment and Reimbursement system has been designed and implemented using Quorum blockchain. Compared to traditional blockchain technologies, such as Ethereum, Quorum blockchain offers a higher transaction throughput and lowers transaction latency. Case studies on each application in the CTMS were conducted to assess the feasibility, scalability, stability, and efficiency of the proposed blockchain-based CTMS. RESULTS 21.6 million Electronic Data Capture transactions were generated and successfully processed through blockchain with an average of 335.4 transactions per second. 1,145 of 6,000 patients were matched in 1.39 seconds using 10 recruitment criteria using an automated matching mechanism implemented by the smart contract. Key features such as immutability, traceability, and stability were also tested and empirically proved through cases studies. CONCLUSIONS This study proposed a comprehensive blockchain-based CTMS that covers all stages throughout the whole clinical trial process. Compared to our previous research, this proposed system has shown an overall better performance. Our system design, implementation, and case studies not only demonstrated the potential of blockchain technology for a holistic solution of CTMS but also more healthcare tasks.