Problems and countermeasures in the supervision of clinical trials of medical devices

doi:10.12092/j.issn.1009-2501.2018.08.001

Abstract

Abstract:

In recent years, China's clinical trial supervision of medical device has achieved certain results. However, there are still some problems in the supervision of medical device clinical trials. For example, there are a large number of medical device products for clinical trials, regulatory responsibilities are not clear, clinical trials lack technical guidance, and clinical trial sponsor, investigator, CRO lack Compliance awareness. This paper analyzes the problems found in the supervision level of medical devices clinical trials in China, and gives some suggestions to solve the problems based on the supervision subjects, which has certain guiding significance for the relevant parties of medical instrument registration.

Key words: medical device, clinical trial, supervision, countermeasure

CLC Number:

R969

LI Xiao, LIU Yang, WANG Xinyi. Problems and countermeasures in the supervision of clinical trials of medical devices[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2018, 23(8): 841-845.

References

［1］徐研偌. 论医疗器械的临床评价［J］. 中国医疗器械信息, 2011, 17(9):1-4.
［2］CFDA. 食品药品监管总局发布医疗器械临床评价技术指导原则［EB/OL］.（2015-05-19）［2018-07-02］.http://samr.cfda.gov.cn/WS01/CL0051/121425.html.
［3］马艳红.我国倡议的国际医疗器械临床评价协调性项目获全票通过［EB/OL］.（2018-03-23）［2018-07-02］.http://www.cnpharm.com/jianguan/201803/23/c253201.html.
［4］秦宇龙. 《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》印发［J］. 中医药管理杂志, 2017, 25(19):190.
［5］国家药品监督管理局. 公开征求《医疗器械临床试验检查要点及判定原则（征求意见稿）》意见［EB/OL］. （2018-05-31）［2018-07-02］.ttp://cnda.cfda.gov.cn/WS04/CL2051/228248.html.
［6］CFDA. 器械备案系统［EB/OL］.［2018-07-02］.http://218.240.145.213:9000/CTMDS/apps/pub/public.jsp.
［7］许伟. 我国医疗器械临床试验监管现状分析及对策探讨［J］. 中国医疗器械信息, 2011, 17(9):5-9.
［8］徐研偌.美国FDA最少工作量原则应用给我们的启示［J］. 中国医疗器械信息, 2011, 17(5):34-36.
［9］司法部. 医疗器械监督管理条例修正案（草案送审稿）［EB/OL］.（2018-06-25）［2018-07-02］.http://www.moj.gov.cn/government_public/content/2018-06/25/fggz_21120.html.
［10］医疗器械技术审评中心.指导原则查询［EB/OL］. ［2018-07-02］.http://www.cmde.org.cn/CL0009/.
［11］药品审评中心.指导原则查询［EB/OL］.［2018-07-02］. http://www.cde.org.cn/zdyz.do?method=initValue&frameStr=0.
［12］FDA. Guidance Documents ［EB/OL］. ［2018-07-02］.https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
［13］邹淑琼, 黄旭霞, 李晔瑜,等. 医院医疗器械临床试验的特点及管理对策［J］. 中国医疗器械杂志, 2015,39(2):146-148.
［14］鄢可书, 侯鹏. 临床数据自查政令下风险偏好型企业参与的多元博弈分析［J］. 中国新药杂志, 2015,24(23):2656-2659.

[1]	CHEN Qun, ZHU Heping, YUAN Xiaolong. Analysis of 197 cases of pentoxifylline injection and exploring supervision mode of rational drug use in hospitals [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2023, 28(8): 948-953.
[2]	WANG Anjing, WANG Yaya, LIANG Xuan, YAN Yajie, SU Jing, LI Caidong. Research progress on mechanisms and therapeutic drugs of peroxisome proliferator-activated receptor in treatment of cholestatic liver disease [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2023, 28(7): 796-808.
[3]	WANG Zhi, ZHOU Xin, HE Xueru, FU Yuhao, XUN Xuejiao, LI Ying, DONG Zhanjun. Clinical research progress of palbociclib in treatment of breast cancer [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2023, 28(2): 205-213.
[4]	DAI Jiahui, SUN Sijia, XIE Xuefeng. Quality management and indicator system for clinical trials of medical devices [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2023, 28(1): 51-58.
[5]	CHEN Jianfang, LOU Donghua. Design of case report form for oncology clinical trials based on CDASH [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2022, 27(7): 762-767.
[6]	LIU Xing, LU Xiaoran, WU Ying, YU Haitao, WANG Xiaomin. Ethical analysis and countermeasures of artificial intelligence application in clinical trials [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2022, 27(3): 322-327.
[7]	ZHU Lili, ZHU Xiuxiu, WANG Wenjun, ZHANG Hailin, LIN Li. Clinical trials of inhalation in pediatric population in China [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2022, 27(2): 178-183.
[8]	LI Shanshan, GU Jingwen, ZHANG Jing, YANG Haijing, LIU Wei, YU Yiqi, ZHANG Wenhong. Design and evaluation of clinical trials of COVID-19 vaccine and monoclonal neutralizing antibody [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2022, 27(2): 190-197.
[9]	DENG Kunhong, LIU Yaxin, SUN Yuanyuan, CHEN Wenjing, YANG Nan, HU Zhanqing, CHEN Kaifeng, HUANG Jie, XIANG Yuxia, YANG Guoping. Literature analysis of the design and results of the First-In-Human clinical trials of drugs from 2009 to 2020 [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2022, 27(1): 77-85.
[10]	ZHENG Ying, ZHANG Ling, YAO Li, WANG Qianhe, ZHU Kexiang. Research progress of PARP inhibitors in pancreatic cancer [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2022, 27(1): 108-115.
[11]	SHE Zhihua, CHEN Zhou, LIANG Songyue. Construction of informatization system of drug clinical trials ethical review based on cloud architecture [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2021, 26(9): 1023-1030.
[12]	SONG Yan, GAO Linyan, ZHANG Yanping, LI Xiang, ZHANG Lan. Application of medical failure mode and effect analysis in blood sample management in phase I clinical trials#br# [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2021, 26(9): 1031-1036.
[13]	OUYANG Chenxi, HUANG Jie, XIANG Yuxia, WANG Xiaomin. Ethical issues and countermeasures of early phase trials [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2021, 26(7): 802-807.
[14]	LIU Xing, WU Ying, LI Yang, WANG Xiaomin. Analysis of ethical issue in the application of artificial intelligence medical devices [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2021, 26(6): 695-699.
[15]	HUANG Lihong, WANG Ling, YAN Fangrong, WEI Zhaohui, ZHAO Yang, XIA Jielai, CHEN Feng. New perspectives on the principle of intention to treat in clinical trials#br# [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2021, 26(4): 449-453.