中国临床药理学杂志2017，Vol.33Issue(17)：1615-1617,1620,4.DOI:10.13699/j.cnki.1001-6821.2017.17.001
临床试验中异常值有无临床意义的若干思考
Some opinion of dose the abnormal value have clinical significance in the clinical trial
张强 1单爱莲2
作者信息
- 1. 兰州军区兰州总医院国家药物临床试验机构,兰州730050
- 2. 北京大学第一医院临床药理研究所,北京100034
- 折叠
摘要
Abstract
How to assess clinical significance and when to report adverse events if the laboratory test results was beyond the normal range of values in the clinical trials.Therefore,we put forward own opinion and the suggestion after refer to some laws,regulations and literature,combining the result of clinical significance determination of 64 study medical.We thought the determine in the process of clinical trial should be diffe-rent from the clinical diagnosis and treatment,which need listed all of the number of abnormal laboratory values to evaluate the safety of the drug from the perspective of clinical trials.It should determine clinical significance when the abnormal laboratory values can make clinical diagnosis before they participate the drug clinical trials,as well as,it should determine no clinical significance if the degree have no sizing rise after reference CTCAE when the subjects out group.We can report adverse events when an abnormal laboratory values will affect the safety evaluation of the drug and need special handling,on the contrary,no need to report adverse events if it's an effectiveness observation indexes.关键词
药物临床试验/异常值/异常有临床意义Key words
drug clinical trial/abnormal value/clinical significance分类
医药卫生引用本文复制引用
张强,单爱莲..临床试验中异常值有无临床意义的若干思考[J].中国临床药理学杂志,2017,33(17):1615-1617,1620,4.
