中国医院用药评价与分析2024，Vol.24Issue(11)：1297-1302,6.DOI:10.14009/j.issn.1672-2124.2024.11.002
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
摘要
Abstract
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 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.关键词
14C标记/物质平衡/临床研究/研究方案/统计分析Key words
14 C labeled/Mass balance/Clinical trials/Research protocols/Statistic analysis分类
医药卫生引用本文复制引用
尹航,刘淑洁,张美娟,董瑞华,贺锐锐..我国14C标记人体物质平衡临床研究方案的统计分析[J].中国医院用药评价与分析,2024,24(11):1297-1302,6.基金项目
国家"重大新药创制"科技重大专项资助项目(No.2018ZX09711003-014-001) （No.2018ZX09711003-014-001）
首都卫生发展科研专项(No.首发 2022-2Z-20215) （No.首发 2022-2Z-20215）
