肿瘤药学2024，Vol.14Issue(6)：673-678,6.DOI:10.3969/j.issn.2095-1264.2024.06.04
单中心抗肿瘤药物Ⅰ期临床试验中研究参与者筛选失败原因分析及对策探讨
Analysis on the reasons and countermeasures for participant screening failure in single-centre phase Ⅰ clinical trials of anti-tumor drugs
苏禾 1李慧 2张子易 2李海鹏 3徐鹏 1李陆风 1李洪涛2
作者信息
- 1. 蚌埠医科大学第一附属医院 临床试验研究中心,安徽 蚌埠,233004
- 2. 蚌埠医科大学第一附属医院肿瘤外科,安徽 蚌埠,233004
- 3. 蚌埠医学院,安徽 蚌埠,233000
- 折叠
摘要
Abstract
Objective To analyze the reasons for the enrollment failure of participating patients in the phase Ⅰ clinical trials of anti-tumor drugs,and to explore the relevant factors affecting the enrollment of participants and countermeasures.Methods Data from phase Ⅰ clinical trial of anti-tumor drugs conducted at the Clinical Trial Research Centre of the First Affiliated Hospital of Bengbu Medical University between November 2018 and May 2023 were collected.The number of participating patients and screening results were counted,and the reasons for screening failure were analyzed.Results Among 854 participating patients,404 cases failed in the enrollment screening,with a failure rate of 47.31%.The main rea-sons for the screening failure included that the tumor target or biomarker did not meet the requirements(20.79%),presence of exclusionary complications(17.33%),and laboratory results beyond the range specified by the study protocol(16.58%).Conclusion The main reasons for screening failure were not meeting the inclusion and exclusion criteria and voluntary withdrawal of subjects after signing the consent form.In the future,it is necessary to set reasonable inclusion and exclusion standards and optimize the screening process to reduce the screening failure rate of phase Ⅰ clinical trials of anti-tumor drugs.关键词
抗肿瘤药物Ⅰ期临床试验/筛选失败/研究设计/入排标准/原因分析Key words
Phase Ⅰ clinical trial of anti-tumor drugs/Screening failure/Study design/Inclusion and exclusion crite-ria/Reason analysis分类
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苏禾,李慧,张子易,李海鹏,徐鹏,李陆风,李洪涛..单中心抗肿瘤药物Ⅰ期临床试验中研究参与者筛选失败原因分析及对策探讨[J].肿瘤药学,2024,14(6):673-678,6.
