Self-examination and problems analysis of phase Ⅱ and Ⅲclinical trials of traditional chinese medicine in a hsopital
Objective To improve the quality of clinical trials and increase the safety of new drug re-search and development through self-checking clinical trial data of traditional Chinese medicine(TCM).Meth-ods According to the Announcement of the State Food and Drug Administration on the Release of Drug Clin-ical Trial Data on-site Verification Points(2015 No.228)and the Guidelines for ethical review of drug clinical trials,31 clinical trial research projects of TCM conducted in this hospital from January 2019 to January 2022 were self-examined,including 527 research cases.There were 25 phase Ⅱ clinical trials and 6 phase Ⅲ clinical trials.The Problems were summarized and analyzed,and the circumvention measures were put forward.Results The problems of scheme deviation and scheme violation mainly include that super's visit to the win-dows[12.14％(64/527)],inspection items were missed[9.87％(52/527)],and non-standard informed con-sent[5.50％(29/527)].Important problems mainly include that missed medication[4.74％(25/527)],test outliers were not reviewed[11.76％(62/527)],the test outliers not judged clinical significance[7.78％(61/527)],inconsistent with the original data[6.26％(14/527)],etc.The general problems mainly include that not filled in the combined medication[5.69％(30/527)],incomplete filling in adverse events[3.42％(18/527)],and underreporting adverse events[1.71％(9/527)].Conclusion In order to ensure the authenticity and integrity of clinical trial data of traditional Chinese medicine,closed-loop management should be carried out,including quality control,feedback,tracking,acceptance and so on.
Drug clinical trialAdverse eventInformed consentComplianceTraditional Chinses medicine
万方数据
维普
