关键词: 临床事件委员会, 不良事件判定一致率, 药物&#x02160, 期临床试验, 药物&#x02162, 期临床试验

Abstract: Objective To compare the difference in adjudications of adverse events between the Clinical Event Committee (CEC) and investigators, and evaluate the role of CEC in a wide range of clinical studies. Methods Data about adverse events was collected from the Prospective Urban and Rural Epidemiology study in China (PURE-China) and from two drug clinical trials. Inconsistency between CEC and investigators in various studies was compared and evaluated. Results A total of eleven CEC meetings for PURE-China study were conducted between February 2018 and June 2019, and 1 993 end-point events were evaluated. The number of inconsistent adjudications between CEC and investigators was seventy-six, accounting for 3.8%. In a phase Ⅰclinical trial, twenty adverse events were reported, five of which were inconsistent (25.0%). In another phase Ⅲ clinical trial, 197 adverse events were observed, 24.4% of which were inconsistent (48 adverse events). Conclusion The results of this study indicate that CEC meetings for adverse event adjudications can improve the quality and reliability of adverse event evaluation in multi-center clinical studies using unified criteria.

Key words: clinical event committee (CEC), consistency of adverse event adjudication, a phase &#x02160, clinical trial, a phase &#x02162, clinical trial