Ⅰ期临床试验中健康受试者筛选失败原因及影响因素分析  

Analysis of reasons for failure in screening healthy subjects in phase Ⅰ clinical trials

作　　者：张莉[1,2] 孟现民 董平 王斌[2] ZHANG Li;MENG Xian-min;DONG Ping;WANG Bin(Department of Pharmacy,Shanghai Public Health Clinical Center,Shanghai 201508,China;Department of Pharmacy,Huashan Hospital,Fudan University,Shanghai 200040,China;Department of Pharmacy,the Third People’s Hospital of Shenzhen,Shenzhen 518112,Guangdong Province,China)

机构地区：[1]上海市公共卫生临床中心药学部,上海201508 [2]复旦大学附属华山医院药剂科,上海200040 [3]深圳市第三人民医院药学部,深圳518112

出　　处：《复旦学报（医学版）》2023年第2期189-195,212,共8页Fudan University Journal of Medical Sciences

基　　金：上海市“医苑新星”青年医学人才培养资助计划-临床药师项目[沪卫人事(2021)99]。

摘　　要：目的分析Ⅰ期临床试验(PhaseⅠclinical trial,PⅠCT)中健康受试者(healthy subject,HS)筛选失败(screening failure,SF)的原因及影响因素,为今后PⅠCT中HS筛选提供参考。方法对上海市公共卫生临床中心在2016年6月—2020年9月期间完成的PⅠCT的HS筛选进行回顾性研究,统计不合格例次构成比及发生率,分析人口学信息及筛选步骤设置对筛选合格率(eligibility rate,ER)的影响。结果共纳入58项PⅠCT,从12028例受试者中筛选出3315例合格HS,ER 27.6%;不合格例次占比最高的是实验室检查(47.2%),其次是生命体征(vital sign,VS)、辅助检查和人口学信息。筛选过程中纳入烟碱测试(P=0.003)、胸片(P=0.025)或腹部B超检查(P=0.002)对ER有显著影响。结论PⅠCT中HS筛选失败的主要原因是实验室检查,其次是VS、辅助检查和人口学信息不合格;HS筛选过程中增加烟碱测试、胸片或腹部B超可使ER降低。Objective To clarify the reasons for failure in screening healthy subjects(HS),and to demonstrate the factors influencing eligibility of HS for inclusion in phaseⅠclinical trials(PⅠCT).Methods We performed a retrospective study that described the processes of screening HS for inclusion in PⅠCT carried out in Shanghai Public Health Clinical Center between Jun 2016 and Sep 2020.The constituent ratio and incidence of reasons for screening failure(SF)were calculated and the impacts of demographic information and screening steps on the screening eligibility rate(ER)were analyzed.Results A total of 12028 volunteers participated in screening for inclusion in 58 PⅠCT.Of these,3315 were evaluated by clinicians as“healthy”with an eligibility rate(ER)of 27.6%.The participants failing screening because of abnormal laboratory examination accounted for 47.2%of exclusions,followed by abnormal vital signs(VS),abnormal auxiliary examination and unqualified demographic information.The performance of urine nicotine test made a significant difference to ER(P=0.003),along with chest radiograph(P=0.025),and abdominal ultrasound(P=0.002).Conclusion The main reason for exclusion in the screening of HS is abnormal laboratory examination,followed by abnormal VS,abnormal auxiliary examination,and unqualified demographic information.Inclusion of urine nicotine test,chest radiograph,or abdominal ultrasound in screening may lower the ER for inclusion.

关 键 词：Ⅰ期临床试验(PⅠCT) 健康受试者(HS) 筛选失败(SF) 筛选合格率(ER) 

分 类 号：R969.4[医药卫生—药理学]