An artificial intelligence and blockchain technology-based data management framework for multicenter randomized controlled trials  

基于人工智能和区块链技术的多中心随机对照试验数据管理框架

作　　者：Dongyuan Yun Xiaohang Wu Xi Chen Yahan Yang Yuanjun Shang Shaopeng Liu Dinesh Visva Gunasekeran Duoru Lin Lixue Liu Lanqin Zhao Wenben Chen Jingjing Chen Ling Jin Yuxuan Wu Jiaming Hong Weiling Hu Zhenzhe Lin Carol Y.Cheung Xiang Chen Peichen Xie Zhenzhen Liu Changhai Ding Patrick Yu-Wai-Man Keming Yu Daniel Shu Wei Ting Yizhi Liu Zibin Zheng Gansen Zhao Zhihua Xia Tien Yin Wong Haotian Lin on behalf of Advanced Technologies Improve Clinical Trial(ATICT)Group 云东源;吴晓航;陈熹;杨雅涵;尚元君;刘少鹏;Dinesh Visva Gunasekeran;林铎儒;刘力学;赵兰琴;陈文贲;陈睛晶;金玲;吴雨璇;洪佳明;胡伟玲;林桢哲;Carol Y.Cheung;陈翔;谢佩辰;刘臻臻;丁长海;Patrick Yu-Wai-Man;余克明;Daniel Shu Wei Ting;刘奕志;郑子彬;赵淦森;夏志华;Tien Yin Wong;林浩添;ATICT工作组

机构地区：[1]State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center,Sun Yat-sen University,Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangdong Provincial Clinical Research Center for Ocular Diseases,Guangzhou 510000,China [2]School of Biomedical Engineering,Sun Yat-sen University,Guangzhou 510000,China [3]School of Computer Science,Guangdong Polytechnic Normal University,Guangzhou 510000,China [4]Singapore Eye Research Institute,Singapore National Eye Center,Singapore,999002,Singapore [5]School of Medical Information Engineering,Guangzhou University of Chinese Medicine,Guangzhou 510000,China [6]Department of Ophthalmology and Visual Sciences,The Chinese University of Hong Kong,Hong Kong 999077,China [7]Zhongshan School of Medicine,Sun Yat-sen University,Guangzhou 510000,China [8]Clinical Research Center,Zhujiang Hospital,Southern Medical University,Guangzhou 510000,China [9]Cambridge Center for Brain Repair and MRC Mitochondrial Biology Unit,Department of Clinical Neurosciences,University of Cambridge,Cambridge,CB20XY,United Kingdom [10]UCL Institute of Ophthalmology,University College London,London,WC1E 6BT,United Kingdom [11]School of Data and Computer Science,Sun Yat-sen University,Guangzhou 510000,China [12]School of Computer Science,South China Normal University,Guangzhou 510000,China [13]College of Cyber Security,Jinan University,Guangzhou 510000,China [14]Duke-NUS Medical School,Singapore,999002,Singapore [15]Tsinghua Medicine,Tsinghua University,Beijing 100010,China [16]Hainan Eye Hospital and Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center,Sun Yat-sen University,Haikou 570100,China [17]Centre for Precision Medicine and Department of Genetics and Biomedical Informatics,Zhongshan School of Medicine,Sun Yat-sen University,Guangzhou 510000,China [18]不详

出　　处：《Science Bulletin》2025年第6期856-860,共5页科学通报(英文版)

基　　金：supported by the National Natural Science Foundation of China(92368205 and 82301265);the Guangdong Provincial Natural Science Foundation for Progressive Young Scholars(2023A1515030170);the Science and Technology Planning Projects of Guangdong Province(2018B010109008);the Science and Technology Planning Project of the Guangzhou Municipal Health Commission(2024A031004);the Basic Scientific Research Projects of Sun Yat-sen University(23ykcxqt002);the China Postdoctoral Science Foundation(2023M734047).

摘　　要：Randomized controlled trials(RCTs)provide optimal evidence of the effectiveness and safety of a new drug,a new medical device,or a new therapeutic strategy with the necessary scientific design[1].Traditional electronic data collection(EDC)systems for clinical trials primarily focus on data entry,validation,and compliance monitoring.However,their reliance on centralized architectures introduces vulnerabilities in data security and integrity。

关 键 词：Artificial Intelligence Multicenter Randomized Controlled Trials Data Security scientific design traditional Blockchain Technology clinical trials randomized controlled trials rcts provide centralized architectures 

分 类 号：R95[医药卫生—药学]