儿科药物临床试验不良事件管理的方案设计质量调查

Investigation on protocol design quality of adverse events management in pediatric clinical drug trials

目的回顾性分析本院药物临床试验不良事件管理的方案设计状况。方法调查我院2009年至今承接的Ⅱ期和Ⅲ期临床试验方案,对照不良事件的方案设计质量评分标准,回顾性分析不良事件设计质量的年均得分及各要素得分率情况。结果本院药物临床试验不良事件管理方案设计质量年均得分及各方面得分率呈现逐年增长的趋势。但部分调研项目仍存在不良事件管理的方案设计缺失,其中得分率较低的指标为不良事件的评价标准(63%)、不良事件的处理及随访(65%)和不良事件的相关定义(67%)。同时根据儿童特殊性以及儿科药物临床试验实际操作经验,设计了2项儿童特殊要素,结果显示得分率也较低,分别是对于无法充分表达的低龄儿童,设计适宜儿童填写的日记卡或安排专人负责记录日记卡(30%)和按年龄段制定不良事件严重程度分级标准(18%)。结论试验方案中完善而周全的不良事件管理设计是项目安全性评价质量的重要保证。考虑到儿童的特殊情况,应基于其自身特点设计适宜于儿童的不良事件管理方案。

Objective To analyze the design quality of adverse events(AEs) management in clinical trials of Beijing Children’s hospital. Methods To investigate the protocols of phase Ⅱ and Ⅲ clinical trials undertaken from 2009 to now in our hospital, according to the design evaluation standard of AEs, the annual average score of the design quality of adverse events and the score rate of each element were analyzed retrospectively. Results The average annual score and score rate of the design quality of AEs management program in our hospital showed an increasing trend year by year. However, some research projects still lacked the scheme design of AEs management. Among them, the indicators with lower score rate were: evaluation criteria of AEs(63%), Handling and follow-up of AEs(65%) and Definition of AEs(67%). At the same time, we designed two special items for children based on the particularity of children and the practical experience of pediatric drug clinical trials, and results showed that the score rate was also low: For young children who cannot fully express themselves, design a diary card sui-table for children or assign a special person to record the diary card(30%). Develop AEs severity grading criteria by age group(18%).Conclusion The design of perfect and comprehensive AE management is an important guarantee of protocol safety evaluation quality. Considering the particularity of children’s clinical trial,the AE management protocol suitable for children should be designed based on its own characteristics.