A Scoping Review of Real-World Study in Vaccine Evaluation

作     者：Lei Wang Hong Yang Lanfang Xia Quanwei Song Na Liu Guomin Zhang Fuzhen Wang Huaqing Wang 

作者机构：National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases(NITFID)BeijingChina National Immunization ProgramChinese Center for Disease Control and PreventionBeijingChina 

出 版 物：《China CDC weekly》 (中国疾病预防控制中心周报（英文）)

年 卷 期：2024年第6卷第16期

页      面：357-362页

核心收录：

学科分类：1004[医学-公共卫生与预防医学(可授医学、理学学位)] 1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：Beijing Natural Science Foundation(L212058) 

主　　题：routine gained traditionally 

摘      要：Real-world study(RWS)gained prominence starting with a significant investigation on ramipril’s impact on hypertension in 1993(1).A key advancement for the Food and Drug Administration(FDA)occurred with the enactment of the 21st Century Cures Act in 2016,emphasizing RWS(2).The FDA’s Real-world Evidence Program establishes real-world data(RWD)as“data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources,while real-world evidence(RWE)is“clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD(3).The proliferation of big data,electronic medical records(EMR),electronic health records(EHR),and medical claims data offers vast information resources facilitating *** access to RWD allows for worldwide monitoring of the impacts of various public health initiatives like vaccination *** randomized clinical trials(RCTs)traditionally gauge vaccine efficacy and shortterm safety,RWS can assess vaccine performance and safety across larger,more diverse populations and are adept at identifying rare events not easily discernible in RCTs due to their infrequency.