关键词: 临床试验, 不良事件, 安全性评价

Abstract:

AIM: To investigate the issues of regulatory issues of adverse events in drug clinical trials.  METHODS: The supervisory quality of adverse events in phase Ⅱ-Ⅳ drug clinical trials and those for post-marketing drug assessment with finished clinical section from 2011 to 2016 was analyzed by referring to clinical trial materials in the institution.RESULTS:The related data of influencing factors in 5 monitoring aspects including recording integrity of adverse events for laboratory examination, consistency of records between source data and case report form, their follow-up visit and review, on-time rate of documentation, and reporting situation of serious adverse events were collected in all the adverse events in 165 drug clinical trials and 39 serious ones among the total. CONCLUSION: There are still some problems in the current safety evaluation system of drug clinical trials. It is imperative to strengthen the training of investigators and all-round process management in order to find a solution to these issues.

Key words: drug clinical trial, adverse event, safety evaluation