An analysis of the causes of failed screening in healthy subjects in a Phase Ⅰ clinical trial
10.13699/j.cnki.1001-6821.2018.08.020
- VernacularTitle:Ⅰ期临床试验健康受试者筛选失败原因的分析探讨
- Author:
Rui-Hua DONG
1
;
Dan-Dan LI
;
Yu-Guang LIANG
;
Fang TIAN
;
Nan ZHANG
;
Ze-Yuan LIU
;
Heng-Yan QU
Author Information
1. 军事医学科学院 附属医院临床药理学研究室
- Keywords:
Phase Ⅰ clinical trial;
subjects screening;
laboratory test;
special examination
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(8):986-989
- CountryChina
- Language:Chinese
-
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.
