药品上市后临床试验的病例募集策略

Cases Recruitment Strategy for Post-marketing Drug Reevaluation

病例募集是上市后药品临床试验质量控制的重要环节,采取有效的募集策略往往有助于增加募集病例的数量、提高募集病例的质量,最终保证临床试验能够保质保量地完成。基于目前上市后药品临床试验的特点和现状分析,针对如何采取有效的策略进行病例募集展开论述,希望能够为以后药品上市后临床研究的质量控制提供思路和帮助。

Casse recruitment is an important factor for the quality control of post-marketing drug clinical trials. Effective recruitment strategies will contribute to increase the case number and improve the study quali- ty,to ensure the clinical trials finished with quality assurance. Here is to analyze the features and status of post-marketing clinical trials, and discuss related strategies on the case recruitment, in the hope of providing some ideas and help to the quality control of post-marketing drug clinical study.