通过对我国药物临床试验质量管理的现状进行分析,提出存在的问题和相应的对策。通过加强监管、实行“三级质控”的管理模式和调动监察员的积极性来提高我国药物临床研究的质量。 Through the analysis of the current situation of the quality management of drug clinical trials in our country, the existing problems and countermeasures are put forward. We should improve the quality of clinical clinical research in our country by strengthening the supervision, implementing the management mode of “three quality control” and mobilizing the ombudsman’s enthusiasm.