Analysis of Worldwide Current Status of Clinical Trials Registration for Medical Biosensors
LU Yan, PAN Lizi, CHEN Juan, OUYANG Zhaolian
Department of Strategic Intelligence Research on Medical Device and Drug, Institute of Medical Information,
Chinese Academy of Medical Sciences, Beijing 100020, China
Abstract：Objective To analyze the current status of clinical trial registration for medical biosensors in the world and to reveal the
clinical application of biosensors in our country. Methods Clinical trial data related to biosensors were retrieved from ClinicalTrials.gov.
Bibliometrics was used to describe the registration status of clinical trials of medical biosensors in the world by analyzing the number
of registrations, distribution of countries/regions, type of sponsors, completion and release of results, study type, trial stage, and
study diseases. Results A total of 183 clinical trials related to medical biosensors were conducted in the world, the largest number
(95) of which were carried out in the U.S. Among the sponsors, 66.67% were universities/hospitals. Among them, 40.98% have been
completed and 10.93% have published results; 52.46% were experimental studies, and the main diseases studied included tumor/
cancer (21) and novel coronavirus infection (12). By the searching date, there were 4 clinical trials related to medical biosensors in
China, which still had a certain gap with the U.S. Conclusion The clinical trials of medical biosensor in the world have increased
significantly in recent 10 years. Our country should further strengthen the application of biosensor in medical field.
卢岩，潘黎姿，陈娟，欧阳昭连. 全球医用生物传感器临床试验注册现状分析[J]. 中国医疗设备, 2023, 38(6): 17-21.
LU Yan, PAN Lizi, CHEN Juan, OUYANG Zhaolian. Analysis of Worldwide Current Status of Clinical Trials Registration for Medical Biosensors. China Medical Devices, 2023, 38(6): 17-21.
