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

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。

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 su- ggestion 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 trims. It should determine clinical signifi- cance 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 adverse events if it＇s an effectiveness , on the contrary, no need to report observation indexes.