With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine（IM） and has become a new unique discipline. During almost 20 years, as one of...With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine（IM） and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review（SR）/meta-analysis（MA） of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, formingqualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process.展开更多
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 Funding of Major Supporting Departments(KFKFC) of Rehabilitation Medicine,Wuxi People's Hospital Affiliated to Nanjing Medical Universitythe Second Batch of National "Ten Thousand Talents Plan" of Scientific and Technological Innovation Leading Talents(No.W02020052)
文摘With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine（IM） and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review（SR）/meta-analysis（MA） of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, formingqualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process.
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.
