摘要
目的探讨分析Ⅰ期临床试验过程中,受试者筛选失败的原因。方法分析参与1项心血管类药物临床试验的106例健康成年受试者筛选过程,对筛选失败的原因进行归纳总结,并探讨可能的影响因素。结果与受试者筛选失败可能有关的因素包括依从性、体格检查、实验室检查和特殊检查等,其中主要原因是实验室检查不合格,占接受该项检查受试者数量的39.76%;其次是动态心电图检查不合格,占接受该项检查受试者的28.89%;心脏超声和依从性因素也各自占接受相关检查的10.0%和10.38%。结论可以从制定适合的实验室正常值范围和深度知情两个方面提高受试者的筛选成功率。
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.
作者
董瑞华
李丹丹
梁宇光
田芳
张楠
刘泽源
曲恒燕
DONG Rui-hua;LI Dan-dan;LIANG Yu-guang;TIAN Fang;ZHANG Nan;LIU Ze-yuan;QU Heng-yan(Clinical Pharmacology Laboratory, Military Academy of Medical Science Hospital, Beijing 100071, China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2018年第8期986-989,共4页
The Chinese Journal of Clinical Pharmacology
基金
国家自然科学基金青年科学基金资助项目(8140130861)
关键词
Ⅰ期临床试验
受试者筛选
实验室检查
特殊检查
Phase I clinical trial
subjects screening
laboratory test
special examination
