早期药物临床试验中血样采集时间超窗的原因分析

目的 利用智能样本管理系统对早期药物临床试验中发生血样采集时间超窗的原因进行统计分析，提出改进措施。方法 以首都医科大学宣武医院和中国人民解放军总医院I期临床研究中心在2019年5月—2021年10月开展的23个早期药物临床试验中药动学血样采集相关数据为研究对象，统计血样采集时间超窗的发生情况，并进行原因分析。结果 共纳入23项临床试验，共计911例健康志愿者，总采血次数34 096次，血样采集时间超窗发生101次，发生率为0.30%。血样采集时间超窗的原因分别为采血困难、采血管负压不足、受试者未遵守方案、研究人员因素等，其中采血困难是主要原因（51.49%）。结论 提高研究人员操作技能，使用智能样本管理系统等措施可以减少血样采集时间超窗的发生，提高临床试验质量。

Analysis of reasons of blood sample collection time beyond the specified time range in early phase clinical trial

Objective To analyze the causes of beyond the specified time range of blood sample collection in early phase clinical trial based on the intelligent sample management system and propose improvement measures. Methods The data of blood sample collection in 23 early phase clinical trials were carried out by Phase I Clinical Research Center of Xuanwu Hospital Capital Medical University and Chinese PLA General Hospital from May 2019 to October 2021. The blood samples beyond the specified time range were counted, and the reasons were analyzed. Results There were 911 participants involved in 23 clinical trials, the total numbers of blood sample collection were 34 096 times, and the number of over time window was 101 (0.30%). The reasons were mainly difficulty in blood collection, insufficient negative pressure in blood collection tubes, subject non-compliance with protocol, and research staff factors. And difficulty in blood collection was the main reason (51.49%). Conclusion Improving investigators operational skills and using intelligent sample management system can reduce the occurrence of beyond the specified time range of blood sample collection, and improve the quality of clinical trial.