中国临床试验数据质量问题的深层原因及对策分析

摘要

Clinical trial data monitoring by China Food and Drug Administration in 2015 demo-nstrated that more than 80% data is not authentic and/or standardized. According to the survey re-sults, the author revealed its underlying causes and made recommendations on improving the quality of clinical trial data in China.%2015年中国国家食品药品监督管理总局对临床试验数据进行核查，中国临床试验数据存在严重的不真实、不规范问题。作者根据调研结果深入剖析数据质量管理中的问题，提出整体提升中国临床试验数据管理水平的建议。