抗肿瘤新药Ⅰ期临床试验外周血样本采集的横断面研究

Cross-sectional study of peripheral blood samples collected in phase Ⅰ clinical trials of new antitumor drugs

目的总结分析抗肿瘤新药Ⅰ期临床试验外周血样本采集的情况,为制定相关政策标准提供依据。方法对中国医学科学院北京协和医学院肿瘤医院2020年7月—2021年7月涉及人类遗传资源申报的Ⅰ期临床试验的采血量进行横断面现况研究,比较分析采血总量、安全性采血量和研究性采血量的分布情况和影响因素。结果纳入的26项Ⅰ期临床试验中,采血总量中位数312 mL,范围在148~479 mL;安全性采血量中位数212 mL,范围在76~373 mL;研究性采血量中位数87 mL,范围在0~193 mL;前2周期采血量占比中位数30.5%,范围在9.4%~59.5%。大部分(88.5%)项目的采血量控制在合理的范围内,抗体偶联类药物、小分子靶向药和首次人体试验的采血量较多。结论抗肿瘤新药Ⅰ期临床试验的外周血样本采集应具有明确的科学依据并将总量控制在合理的范围内,同时建议遵循统一标准、合理设计、控制总量、充分告知、注重沟通的原则,优化临床试验生物样本管理。

Objective To summarize and analyze the collection of peripheral blood samples from phase I clinical trials of antitumor drugs,and to provide the basis for the formulation of relevant policy standards.Methods A cross-sectional survey was conducted on the amount of blood collected in Phase I clinical trials involving the declaration of human genetic resources in the Cancer Hospital of the Chinese Academy of Medical Sciences.The distribution and influencing factors of total blood collection,safety blood collection and research blood collection were compared.Results A total of 26 clinical trials were included.The median volume of total blood collection was 312 mL,ranging from 148 to 479 mL,and the median volume of safety blood collection was 212 mL,ranging from 76 to 373 mL,the median volume of research blood collection was 87 mL,ranging from 0 to 193 mL,and the median proportion of blood collected in the first two cycles was 30.5%,ranging from 9.4%to 59.5%.The total blood collection volume of most projects is controlled within a reasonable range.The antibody-drug conjugate(ADC)drugs,small molecular target drugs and the First-in-human trials have more blood samples.Conclusion The collection of peripheral blood samples in phase I clinical trials of new antitumor drugs should have a clear scientific basis and limit the total amount to a reasonable range.At the same time,it is suggested to optimize the biological sample management of clinical trials by following the principles of unified standards,reasonable design,limiting the total amount,fully informing and paying attention to communication.