Objective To define the concepts and characteristics of real world data(RWD),real world research,real world evidence(RWE)and other related terms so as to better apply RWE to serve the whole life cycle monitoring of ph...Objective To define the concepts and characteristics of real world data(RWD),real world research,real world evidence(RWE)and other related terms so as to better apply RWE to serve the whole life cycle monitoring of pharmaceutical products.Besides,some reference can be provided for drug supervision and medical services to further standardize the clinical application of drugs.Methods Through literature retrieval at home and abroad,the development process of exploring RWE in Europe and America was briefly introduced,and its development status in China was compared and analyzed as well.The application fields of RWE were explored based on the whole life cycle of drugs.Results and Conclusion RWE can provide proof for drug life cycle regulatory evaluation.Some European countries and the United States gradually apply RWE to regulatory decision-making and related policy research.Due to its bright prospect,China is also strengthening the expansion of RWE application fields and exploring its use in-depth.展开更多
文摘Objective To define the concepts and characteristics of real world data(RWD),real world research,real world evidence(RWE)and other related terms so as to better apply RWE to serve the whole life cycle monitoring of pharmaceutical products.Besides,some reference can be provided for drug supervision and medical services to further standardize the clinical application of drugs.Methods Through literature retrieval at home and abroad,the development process of exploring RWE in Europe and America was briefly introduced,and its development status in China was compared and analyzed as well.The application fields of RWE were explored based on the whole life cycle of drugs.Results and Conclusion RWE can provide proof for drug life cycle regulatory evaluation.Some European countries and the United States gradually apply RWE to regulatory decision-making and related policy research.Due to its bright prospect,China is also strengthening the expansion of RWE application fields and exploring its use in-depth.
