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

摘要:

目的 分析抗肿瘤药物Ⅰ期临床试验研究参与者筛选失败的原因，并探讨影响研究参与者入组的相关因素及解决对策。方法 收集2018年11月至2023年5月蚌埠医科大学第一附属医院临床试验研究中心开展的抗肿瘤药物Ⅰ期临床试验数据，统计研究参与者数量和筛选结果，分析筛选失败的原因。结果 854例研究参与者中筛选失败404例，筛败率为47.31%。筛选失败的主要原因有肿瘤靶点或生物标志物不符合要求（20.79%）、发现排除性的合并症（17.33%）及实验室结果超出研究方案规定的范围（16.58%）。结论 不符合入排标准、签署同意书后自愿退出是筛选失败的主要原因。未来需要设置合理的入排标准，优化筛选流程，以降低抗肿瘤药物Ⅰ期临床试验的筛败率。

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 reasons 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.