Randomized clinical trials(RCTs)have long been recognized the gold standard for regulatory approval in the drug development.However,RCTs may not be feasible in some diseases and/or under certain situations,and finding...Randomized clinical trials(RCTs)have long been recognized the gold standard for regulatory approval in the drug development.However,RCTs may not be feasible in some diseases and/or under certain situations,and findings from RCTs may not be generalized to real-world patients in routine clinical practice.Real-world evidence(RWE),which is generated from various real-world data(RWD),has become more and more important for the drug development and clinical decision-making in the digital era.This paper described RWD and real-world data studies(RWDSs),followed by the characteristics and differences between RCTs and RWDSs.Furthermore,the challenges and limitations of RWD and RWE were discussed.Finally,this paper highlights that the efforts must be made during RWE generation from data collection/database selection,study design,statistical analysis,and interpretation of the results to minimize the biases and confounding effects.展开更多
文摘Randomized clinical trials(RCTs)have long been recognized the gold standard for regulatory approval in the drug development.However,RCTs may not be feasible in some diseases and/or under certain situations,and findings from RCTs may not be generalized to real-world patients in routine clinical practice.Real-world evidence(RWE),which is generated from various real-world data(RWD),has become more and more important for the drug development and clinical decision-making in the digital era.This paper described RWD and real-world data studies(RWDSs),followed by the characteristics and differences between RCTs and RWDSs.Furthermore,the challenges and limitations of RWD and RWE were discussed.Finally,this paper highlights that the efforts must be made during RWE generation from data collection/database selection,study design,statistical analysis,and interpretation of the results to minimize the biases and confounding effects.
