我国14C标记人体物质平衡临床研究方案的统计分析

Statistical Analysis of Clinical Research Protocols for 14 C Labeled Human Mass Balance Study in China

目的:了解我国14 C标记人体物质平衡临床研究方案,评价研究方案与《放射性标记人体物质平衡研究技术指导原则》(以下简称“指导原则”)要求的相符性,为后续该类型研究的开展提供参考。方法:检索国家药品监督管理局药品审评中心药物临床试验登记与信息公示平台登记的14 C标记放射性物质平衡临床研究,检索时限为建库至2023年12月31日,收集研究方案的基本情况、受试者特征、纳入与排除标准、研究药物特征、样本收集时长、入组例数和研究开展时机等研究方法相关的特征性数据,并比较其与指导原则的相符性。结果:共纳入137项研究,其中化学药136项,中药单体1项;口服药物130项,注射药物7项;适应证中,实体瘤、非小细胞肺癌、血液系统恶性肿瘤和2型糖尿病等占比较大,研究设计较规范。结论:绝大多数14 C标记人体物质平衡临床研究方案的方法学特征性数据与指导原则要求相符,但是在研究开展时机方面与指导原则建议有较大不同,后续研究仍需加以关注。

OBJECTIVE:To familiarize the clinical research protocols for 14 C labeled human mass balance studies in China,and evaluate the consistency between the research protocols and the requirements of the Guidelines for the Study of Material Balance in the Human Body with Radioactive Labeling Guidance for the Mass Balance Study in the Human Body Using Radioactive Labeling Technology(hereinafter referred to as“the guidance”),so as provide reference for the subsequent development of trials.METHODS:14 C labeled human mass balance clinical trials registered in the Clinical Trials Registry Platform of Center for Drug Evaluation,National Medical Products Administration were retrieved,the retrieval time was from the establishment of the database to Dec.31 st,2023.Characteristic data related to study methods,such as basic information about study protocols,characteristics of participants,inclusion and exclusion criteria,drug characteristics,sample collection duration,number of enrolled cases,and timing of study implementation,were collected and compared with the guidance.RESULTS:A total of 137 trials were enrolled,including 136 chemical drugs and 1 traditional Chinese medicine monomer.There were 130 oral drugs and 7 injections.Among the indications,solid tumors,non-small cell lung cancer,hematological malignancies and type 2 diabetes mellitus accounted for a large proportion,and the study design was relatively standardized.CONCLUSIONS:The majority of characteristic data related to the clinical research protocols for 14 C labeled human mass balance studies are consistent with the requirements of the guidance,yet the timing of the studies differs significantly from the guidance recommendations,and follow-up studies still needs to be paid attention to.