节点文献
药物临床试验数据核查常见问题与对策建议
Common issues and recommendation for inspection of drug clinical trial data
【摘要】 回顾性分析北京大学人民医院自"7·22"后药物临床试验数据核查情况。针对我院接受临床试验核查的项目进行统计,对药物临床试验数据核查存在的常见问题进行了梳理和归纳,并对如何保证药物临床试验数据真实可靠、试验结果客观可信,提出对策和建议。
【Abstract】 We conducted a retrospective analysis of the inspection of clinical trial data after " 7 · 22 " announcement.The features of the involved trials in this hospital were analyzed.The common issues of the inspection of clinical trial data were sorted and analyzed.Suggestions were put forward on how to ensure the reliability and integrity of clinical trial data.
【基金】 北京国际医药临床研发平台基金资助项目
- 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2017年22期
- 【分类号】R95
- 【被引频次】22
- 【下载频次】1003