TY -非盟的壮族,燕盟——张Luxia AU -高,西苑盟——Shae Zon-Yin AU -蔡,杰弗里·J P AU - Li Pengfei盟,害羞的,来说Chi-Ren PY - 2022 DA - 2022/6/27 TI -重建临床试验管理系统使用区块链技术:系统设计、开发、和案例研究乔- J地中海互联网Res SP - e36774六世- 24 - 6 KW -区块链KW -临床试验KW -临床试验管理系统KW -电子数据捕获KW -智能合同AB -背景:临床试验管理系统(CTMS)是一套专门的生产力工具，用于管理从研究计划到结束的临床试验过程。使用ctms在交付高效、可审计和可可视化的临床试验方面显示出显著的好处。然而，目前的CTMS市场是分散的，大多数CTMS由于无法支持关键功能(例如跨多个站点捕获的数据不一致)而未能满足预期。区块链技术是一种新兴的分布式账本技术，通过使用其独特的特性，如透明度、可追溯性、不可变性和安全性，被认为有可能为当前CTMS挑战提供一个整体解决方案。目的:本研究旨在通过利用区块链技术的独特特性来重新设计传统的CTMS，以创建一个安全、可审计、高效和可推广的CTMS。方法:一个全面的、基于区块链的CTMS，涵盖临床试验的所有阶段，包括可共享的试验主文件系统;快速招生和简化招生系统;一个及时、安全、一致的电子数据采集系统;可重复的数据分析系统; 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 studies on each application of the CTMS were conducted to assess the feasibility, scalability, stability, and efficiency of the proposed blockchain-based CTMS. Results: A total of 21.6 million electronic data capture transactions were generated and successfully processed through blockchain, with an average of 335.4 transactions per second. Of the 6000 patients, 1145 were matched in 1.39 seconds using 10 recruitment criteria with an automated matching mechanism implemented by the smart contract. Key features, such as immutability, traceability, and stability, were also tested and empirically proven through case studies. Conclusions: This study proposed a comprehensive blockchain-based CTMS that covers all stages of the clinical trial process. Compared with our previous research, the proposed system showed an overall better performance. Our system design, implementation, and case studies demonstrated the potential of blockchain technology as a potential solution to CTMS challenges and its ability to perform more health care tasks. SN - 1438-8871 UR - //www.mybigtv.com/2022/6/e36774 UR - https://doi.org/10.2196/36774 UR - http://www.ncbi.nlm.nih.gov/pubmed/35759315 DO - 10.2196/36774 ID - info:doi/10.2196/36774 ER -