Problems with Reports of Adverse Events in Drug Clinical Trials
Objective To analyze the problems with reports of adverse events in clinical trials and improve the quality and level of clinical trials.Methods The quality control reports of 21 clinical trials in an institution were collected,and the problems with wording of adverse events were statistically analyzed according to"Key Points for On-site Verification of Drug Clinical Trial Data".Results In the 21 clinical trials,197 errors related to reports of adverse events were found,Among them,17 errors involved the consistency between the starting-time of collection and the trial protocol(8.6%),26 were related to incomplete follow-up(13.2%),58 were concerned with substandard recording of names of adverse events(29.4%),49 were the lack of reports of adverse events(24.9%),34 were cases of misjudgment of clinical significance of abnormalities(17.3%),and 13 were cases of misjudgment of correlations with the tested drugs(6.6%).Conclusion There are a number of problems with the recording and evaluation of adverse events,which deserves the attention from clini-cal trial institutions and researchers in the course of clinical trials.
drug clinical trialsafety evaluationadverse events
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