Investigation and analysis of existing problems in clinical trials of drugs and countermeasures
LIU Feng
DENG Gui-xin
LI Xue-qin
WANG Gui-feng
Abstract：Objective:To summarize our institutional investigators problems existied in the implementation of drug clinical trials and put forward corresponding countermeasures.Methods:Questionnaire of self-administered questionnaires was used to investigate the subjects who participated in the clinical trial of Zhongshan People's Hospital.The survey data were analyzed with SPSS statistical software.Results:A total of 122 investigators were enrolled in the study,there are many problems existed in the study,such as investigators' enthusiasm is not high to participate in clinical trials,the signing of informed consent form,AE/SAE recording and processing,clinical trial electronic history record,research drug management,combined medication and the record,etc.Conclusion:clinical trials can be carried out by a full-time clinical research coordinator,diversified training to enhance the investigators' clinical research thinking,research departments to strive for more high-level clinical trials to improve the enthusiasm of researchers and other measures to solve problems,so as to standardize the operation rules of clinical trials and improve the quality of clinical trials.
Keywords：drug clinical trialinvestigatorinvestigation and analysiscountermeasure research
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2059-2063 )