摘要
当前,药物临床试验面临着两大难题:数据真实性及相关人员操作规范性。现阶段国内外在药物临床试验方面的监管主要以事后监查为主,在数据质量管理以及操作规划标准的监查方面存在一定的时延性。而区块链通过非对称加密、哈希算法及智能合约等技术,可以在保证受试者隐私信息的前提下,提高政府相关监督机构的监管效率,提升药物临床试验数据管理的透明度;同时,与物联网的紧密结合可以实现对标准操作规范的进一步核查,与人工智能的结合有望实现受试者的自动招募。
Clinical drug trials are confronted with two major issues:first,data authenticity,for instance,if any data falsification is conducted during the whole trial;second,whether the standard of procedure is accordingly conducted throughout the whole trial or not.Currently,both domestic and overseas clinical drug trials are not supervised without delay(ex-post inspection).Blockchain technology can improve the efficiency of Food and Drug Administration and the transparency of trials while the rights and safety of human research subjects are guaranteed by the integrated technology such as chained structure,asymmetry key algorithm,hash algorithm,and smart contract.Furthermore,with the assistance of internet of things(IoT)and artificial intelligence(AI),the actual supervision over the whole trial and automatic recruitment of human research subjects are expected to achieve.
作者
云东源
陈文贲(综述)
林浩添(审校)
YUN Dongyuan;CHEN Wenben;LIN Haotian(State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center,Sun Yat-sen University,Guangzhou 510060;Center of Precision Medicine,Sun Yat-sen University,Guangzhou 510080,China)
出处
《眼科学报》
2021年第1期46-49,共4页
Eye Science
基金
国家重点研发计划(2018YFC0116500)
国家自然科学基金面上项目(81770967)
广东省科技厅-广东省重点领域(2018B010109008)
广东省科技创新领军人才(2017TX04R031)
广东省科技计划项目-科技基础条件建设领域(2019B030316012)。
关键词
区块链应用
药物临床试验
优化管理效率
blockchain technology
pharmaceutical clinical trial
medical management optimization