目的 结合体外诊断试剂现行法规和药物滥用检测试剂自身的特点，阐述其临床研究要点。方法 对该类试剂管理分类、研究方法、临床试验方案设置、临床试验样本选择、结果的统计学分析以及临床试验报告撰写等方面进行了详细解析。结果 确立了体外诊断试剂和药物滥用检测试剂的研究方法。结论 体外诊断试剂和药物滥用检测试剂的临床研究应从试剂本身的临床预期用途出发，重点针对试剂定性的准确性、特异性进行科学的临床考察。

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.