Discussion on Problems in Medical Device Clinical Trials and Relevant
Solutions
YANG Chun-mei,
YUAN Dan-jiang, XU Zhen
National Pharmaceutical Clinical Trial
Institute, Jingzhou HospitaI, Tongji
Medical College, Huazhong University
of Science and Technology, Jingzhou
Hubei 434020, China
Abstract：In view of the problems in the full process of medical device clinical trials, the paper
summarized the problems from four aspects, including regulators, sponsors, investigators and subjects.
Additionally, relevant solutions were explored so as to play a positive role in accelerating the medical
device clinical trial and improving its management level and quality.
杨春梅，袁丹江，徐珍. 医疗器械临床试验中存在的问题与对策探讨[J]. 中国医疗设备, 2016, 31(8): 126-128.
YANG Chun-mei,
YUAN Dan-jiang, XU Zhen. Discussion on Problems in Medical Device Clinical Trials and Relevant
Solutions. China Medical Devices, 2016, 31(8): 126-128.
