Although there is guidance from different regulatory agencies,there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monito...Although there is guidance from different regulatory agencies,there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee(DMC)for clinical studies of Chinese medicine.We names it as a Chinese Medicine Data Monitoring Committee(CMDMC).A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs.Subsequently,a community standard on CMDMCs(T/CACM 1323-2019)was issued by the China Association of Chinese Medicine on September 12,2019.This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs,which will further develop the scientific integrity and quality of clinical studies.展开更多
基金Supported by China National Key Program of New Drug Research and Development(No.2011ZX09304-07)。
文摘Although there is guidance from different regulatory agencies,there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee(DMC)for clinical studies of Chinese medicine.We names it as a Chinese Medicine Data Monitoring Committee(CMDMC).A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs.Subsequently,a community standard on CMDMCs(T/CACM 1323-2019)was issued by the China Association of Chinese Medicine on September 12,2019.This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs,which will further develop the scientific integrity and quality of clinical studies.
