@文章{info:doi/10.2196/18938，作者="平野友信与元桥，友光与奥村，小介与高介，健太郎与黑木，太友与市川，大介与松冈，裕隆与大chi，荣介与上野，太郎"，标题="乳腺癌临床试验中使用区块链的数据验证与验证:监管沙盒"，期刊="J Med Internet Res"，年="2020"，月="月"，日="2"，卷="22"，数="6"，页="e18938"，关键词="区块链;临床试验;数据管理;验证;乳腺癌;背景:临床试验中数据的完整性至关重要，但目前的数据管理流程过于复杂和劳动密集型。因此，临床试验容易消耗大量的预算和时间，并且存在人为错误和数据伪造的风险。区块链技术有潜力解决其中一些挑战。目的:本研究旨在验证一种使用区块链技术的临床试验医疗数据安全系统。方法:我们开发了基于区块链的临床试验数据管理系统，并通过乳腺癌临床试验对系统进行了测试。 The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. Results: We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. Conclusions: We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials. ", issn="1438-8871", doi="10.2196/18938", url="//www.mybigtv.com/2020/6/e18938", url="https://doi.org/10.2196/18938", url="http://www.ncbi.nlm.nih.gov/pubmed/32340974" }