中国临床药理学杂志2018，Vol.34Issue(8)：986-989,4.DOI:10.13699/j.cnki.1001-6821.2018.08.020
Ⅰ期临床试验健康受试者筛选失败原因的分析探讨
An analysis of the causes of failed screening in healthy subjects in a Phase Ⅰ clinical trial
摘要
Abstract
Objective Subjects failed to filter the reasons were summarized through the analysis of phase Ⅰ clinical trial process.Methods The reasons for the screening failure were summarized and the possible influencing factors were discussed by analyzing the screening process in a clinical trial of cardiovascular drugs that involved 106 cases of healthy adults.Results Compliance,physical examination,laboratory tests and special examinations may be related to the screening failure,among which laboratory test failure was the leading cause (39.76％) followed by Holter electrocardiogram (28.89％),while echocardiography and compliance factors respectively accounted for 10.0％ and 10.38％.Conclusion The screening success rate can be improved by developing a suitable range of laboratory normalization and depth of knowledge.关键词
Ⅰ期临床试验/受试者筛选/实验室检查/特殊检查Key words
Phase Ⅰ clinical trial/subjects screening/laboratory test/special examination分类
医药卫生引用本文复制引用
董瑞华,李丹丹,梁宇光,田芳,张楠,刘泽源,曲恒燕..Ⅰ期临床试验健康受试者筛选失败原因的分析探讨[J].中国临床药理学杂志,2018,34(8):986-989,4.基金项目
国家自然科学基金青年科学基金资助项目(8140130861) （8140130861）
