The cornerstone of scientifically valid and ethically sound clinical trials is in compliance with established global quality requirements.Although China has made significant progress over the past 20 years in terms of...The cornerstone of scientifically valid and ethically sound clinical trials is in compliance with established global quality requirements.Although China has made significant progress over the past 20 years in terms of the clinical trial quantity[1],quality and participation in multiregional trials[2],there still remain concerns regarding the trial quality,which could be associated with the self-inspection initiative in 2015[3].展开更多
基金Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences,Grant/Award Number:2021-I2M-1-045National Anti-Tumor Drug Surveillance System of National Cancer Center,Grant/Award Number:DSS-YSF-2023009National Key Research and Development Program of China,Grant/Award Number:2021YFE0192400。
文摘The cornerstone of scientifically valid and ethically sound clinical trials is in compliance with established global quality requirements.Although China has made significant progress over the past 20 years in terms of the clinical trial quantity[1],quality and participation in multiregional trials[2],there still remain concerns regarding the trial quality,which could be associated with the self-inspection initiative in 2015[3].