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Received:June 13, 2023 Published Online:November 20, 2023
Received:June 13, 2023 Published Online:November 20, 2023
中文摘要: 目的 探讨 Ⅰ 期临床试验中受试者筛选失败的原因。方法 汇总2019年2月至2022年12月开展的10项Ⅰ 期临床试验受试者筛选数据，对筛选失败原因进行分类分析，探讨可能的影响因素。结果 受试者筛选失败的因素包括实验室检查、其他辅助检查、生命体征及体格检查、依从性等，其中主要因素是实验室检查结果异常，占36.61%，其次是其他辅助检查结果异常，占31.35%。结论 科学判断理化检查异常值，充分知情，重视招募，仔细筛选，建立受试者数据库，加强受试者依从性管理等措施是提高 Ⅰ 期临床试验受试者筛选合格率的有力保障。
Abstract:Objective To explore and analyze the reasons on the failure of subjects screening in Phase Ⅰ clinical trials. Methods The subjects screening data of 10 Phase I clinical trials conducted from February 2019 to December 2020 were summarized, and the reasons of screening failure were classified and analyzed to explore the possible influencing factors. Results The reasons of screening failure included laboratory examinations, other auxiliary examinations except the laboratory, vital signs and physical examination, compliance, etc. The main reasons were unqualified laboratory examinations(36.61%) and other auxiliary examinations(31.35%). Conclusion Scientific judgment of abnormal values in physical and chemical examinations, emphasis on recruitment, careful screening, establishment of a subject database, and strengthening of subject compliance management are effective measures to improve the pass rate of subject screening in Phase I clinical trials.
keywords: Phase I clinical trial Subject screening Screening failure Laboratory examination Healthy subjects
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基金项目:江苏省药品监督管理局科研计划课题（202105）
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