临床试验中异常值有无临床意义的若干思考

发布时间：2018-05-03 21:38

本文选题：药物临床试验 + 异常值　；参考：《中国临床药理学杂志》2017年17期

【摘要】：在临床试验中,实验室的化验结果超出检测值的正常范围时,何时判定为异常有意义,何时判定为无意义,何时填报药物不良事件,为此,我们查阅了相关法律法规和文献,结合64例研究病例中有关异常值判定的结果,提出了自己的意见和建议,认为临床试验过程中异常的判定应与临床诊治过程中不同,要从试验的角度判定药物的安全性,列出引起某项化验值异常的所有病例数,对于可作出临床诊断的异常值,在入组前均可判定为异常有临床意义,出组后参考常见药物不良事件评价标准(CTCAE)的判定,如无分级程度的升高,均可判定异常无临床意义;如果某项实验室检查指标异常会影响评价安全性,且需特殊处理则判定为药物不良事件,但若是有效性观察指标,则不需要报药物不良事件。
[Abstract]:In clinical trials, when laboratory results exceed the normal range of test values, when they are judged to be abnormal, when they are considered meaningless, and when adverse drug events are reported, we have consulted the relevant laws, regulations and literature. Combined with the results of 64 cases of study, the authors put forward their own opinions and suggestions, and concluded that the determination of abnormal value in clinical trials should be different from that in clinical diagnosis and treatment, and the safety of drugs should be determined from the point of view of trial. To list all the cases that caused the abnormality of a certain test value, for the abnormal value that can be diagnosed clinically, it is of clinical significance to determine the abnormal value before entering the group, and the criteria for evaluation of common adverse drug events (CTCAE) should be referred to in the evaluation standard of common adverse drug events (CTCAE) after the departure of the group. If there is no increase in the degree of grading, the abnormality can be judged to be of no clinical significance; if an abnormal laboratory examination will affect the safety of the evaluation, and special treatment is required, it will be judged as an adverse drug event, but if the effectiveness is observed, There is no need to report adverse drug events.
【作者单位】：兰州军区兰州总医院国家药物临床试验机构;北京大学第一医院临床药理研究所;
【分类号】：R95

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