基于药物临床试验的健康受试者筛选失败原因分析及对策探讨  

Analysis of reasons and countermeasures of healthy subjects screening failure based on drug clinical trials

作　　者：王悦 瞿惠娟 王书会[2] WANG Yue;QU Hui-juan;WANG Shu-hui(The First Affiliated Hospital of USTC,Hefei 230001,Anhui;Qilu Hospital of Shandong University,Jinan 250000,Shandong)

机构地区：[1]中国科学技术大学附属第一医院(安徽省立医院),安徽合肥230001 [2]山东大学齐鲁医院感染管理处,山东济南250000

出　　处：《安徽医专学报》2025年第1期8-11,共4页Journal of Anhui Medical College

摘　　要：目的:研究药物临床试验中受试者筛选失败常见原因,探讨影响药物临床试验健康受试者筛查的潜在因素,并探讨提高筛选成功率的相应措施。方法:统计分析2022年6月-2023年12月在某医院开展的药物临床试验健康受试者临床资料。结果:已完成的11项临床试验共筛选受试者1914例,其中,成功筛选545例(占28.47%);未通过筛选1369例(占71.53%)。相关因素分析表明,实验室检查异常、生命体征检查异常、主动退出是影响筛选成功率的主要因素。结论:对受试者进行规范培训,加强宣教,提供适宜的检查环境,有利于提高筛选成功率。Objective:To analyze the common reasons for the failure of subject screening in drug clinical trials,explore the potential factors affecting the screening of healthy subjects in drug clinical trials,and formulate corresponding measures to improve the screening success rate.Methods:Statistical analysis of clinical data of healthy subjects in drug clinical trials conducted at the hospital from June 2022 to December 2023.Results:A total of 1914 subjects were screened for 11 completed clinical trials,among which 545 were successfully screened(accounting for 28.47%);1369 did not pass the screening(accounting for 71.53%).The analysis indicated that abnormal laboratory tests,abnormal vital signs,and voluntary withdrawal were the main factors affecting the screening success rate.Conclusion:Conducting standardized training for subjects,strengthening education,and providing a suitable examination environment are conducive to improving the screening success rate.

关 键 词：药物临床试验 健康受试者 筛选成功率 筛选失败因素 

分 类 号：R95[医药卫生—药学]