Research On Quality Management In Clinical Trials Of Drugs

Objective:To investigate the problems appeared in the process of clinical trials in ourcountry, to understand the status of the internal quality control of clinical trials, and draw onadvanced foreign management concepts, combined with the actual situation of domestic clinicaltrials, the accessible advice to improve the internal quality control of clinical trials are putforward, so as to ensure the smooth conduct of clinical trials.Method:This study is carried out through literature review, checks of drug clinical trialprograms and questionnaires manner. Through literature review to analysis the problems in theprocess of clinical trials in clinical trial agencies in our country; Through on-site inspect clinicaltrial projects of a clinical trial agency to identify the problems inthe process of clinical trials;Combined with literature review, checks of drug clinical trial programs and the actual situation,design subjects and researchers questionnaire to investigate problems in the process of clinicaltrials.Result: The research shows that the problems existing in clinical trials are as follows: thereare many problems in the informed consent process; subjects have poor compliance; drugadministration is not regulated; researchers lack the grasp for GCP and have poor compliance;subjects compensation mechanism is not perfect; the time on clinical trials are limited.Conclusion: To solve the above problems, the suggestions are: normative systems, effectivesupervision; establish a comprehensive training system; introduce full-time CRC; fully informed,valid consent; regulate drug administration; perfect subjects compensation mechanism; improvesubjects’ compliance; introduce information management systems.