临床试验中AE/SAE判别与处置的现状及趋势

Current Situation and Trend of Judgment and Disposal on AE/SAE in Clinical Trials

合理完善与规范临床试验中不良事件的判断标准与处置流程意义重大。这也是研究者、临床试验机构和监管部门十分关注的热点问题。通过检索和回顾相关文献,从保证药物临床试验安全性着手,明确不良事件定义,探讨药物临床试验不良反应因果判定关联性、不良事件通用术语评价标准(CTCAE)在健康受试者临床试验中的适用性、以及严重不良反应的上报与处置流程的发展更新。通过借鉴国外标准及追踪最新进展与趋势,提出在我国建立临床试验不良事件的判断策略具有重要的意义,并对今后临床试验的相关工作提出了新的思考和展望。

It is very important to standardize the judgment criteria and disposal process of adverse events in clinical trials,which is also a great concern to investigators,clinical trial institutions and health authorities.By literature searching and reviewing on safety of current drug clinical trials,we clarified the definition of adverse events,explored the causality assessment of adverse events in clinical trials,evaluated the applicability of the Common Terminology Criteria for Adverse Events(CTCAE)to healthy volunteers in clinical trials,as well as updated the reporting and disposal process of serious adverse drug reactions.Referring foreign standards and latest progress and trends,we pointed out the great significance to propose a strategy for determining adverse events in clinical trials in China,and put forward new considerations and prospects for future clinical trials.