摘要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.
作者LIU Jun[1]WANG Nian[1]DANG Hai-xia[2]CHEN Bing-wei[3]ZHANG Li[4]ZOU Chong[5]ZHONG Cheng-liang[6]HUANG Ju-kai[4]LIU Qiong[1]YU Ya-nan[1]JIANG Meng[5]LIANG Wei-xiong[7]CHEN Qi-guang[3]WANG Yong-yan[1]SHEN Chun-ti[8]WANG Zhong[1]World Federation of Chinese Medicine Societies—Data Monitoring Committee for Clinical Studies学术成果认领
作者单位Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700 ,China[1]China Academy of Chinese Medical Sciences,Beijing 100700 ,China[2]School of Public Health,Southeast University,Nanjing 210009 ,China[3]Dongfang Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100078 ,China[4]Jiangsu Provincial Hospital of Traditional Chinese Medicine(Affiliated Hospital of Nanjing University of Traditional Chinese Medicine),Nanjing 210029 ,China[5]First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381 ,China[6]Guangdong Hospital of Traditional Chinese Medicine,Guangzhou 510120 ,China[7]Changzhou Traditional Chinese Medicine Hospital,Changzhou,Jiangsu Province 213004 ,China[8]
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