摘要
《药物临床试验质量管理规范》的实施使我国临床研究质量不断提高,受试者权益保护问题亦日益受到重视。大规模临床试验存在干预时间长、样本量大、参加单位多、研究者水平参差、试验周期长、不良事件多等特点,在受试者权益保护方面涉及面广、细节复杂,鲜有经验总结。本文介绍了国家科技攻关项目《芪参益气滴丸对心肌梗死二级预防的临床试验》中的受试者权益保护方法,以供参考。
With the implementation of ＂Good Clinical Practice＂,the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject.Large scale clinical trials are primarily featured by long-term intervention,large sample size,many participant organizations,different levels of investigators, long test periods,and lots of adverse events.Consequently,the protection of subject is full of extensive complexities and diffi culties and currently there is little experience to refer to.Hence,the article introduces the subject＇s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction（MISPS-TCM）.
出处
《中国循证医学杂志》
CSCD
2011年第5期594-596,共3页
Chinese Journal of Evidence-based Medicine
基金
国家科技攻关项目(编号:2004BA716B01)
国家自然科学青年基金项目(编号:81001538)
教育部新世纪优秀人才计划(编号:NCET-09-0613)
关键词
大规模临床试验
受试者权益保护
中医药
Large-scale clinical trial
Protection of subject
Traditional Chinese medicine
