Objective To discuss the main points of clinical trails of drug abuse detection reagents. Methods Considering both the active regulations of IVD and the drug abuse detection reagents own characteristics, the characteristics of clinical trails of the drug abuse detection reagents were described in detail. Results Significant problems have been settled such as classification, study method, clinical trail scheme setup, sample selection, statistical analysis of results and reports composing. Conclusion Clinical trails of drug abuse detection reagents should be carried out scientifically and focus on the accuracy and specificity，based on the active regulations and it’s own clinical use.