【摘要】 传统的随机对照临床试验在长期使用过程中暴露出一些不足,这促使越来越多的研究者将目光投向真实世界证据(RWE)。真实世界数据(RWD)作为真实世界研究(RWS)的重要基础,决定了RWS是否能为监管和审评机构提供可靠的RWE。目前RWD在使用过程中存在一些问题,表现为数据非结构化和零碎化、可及性差、数据的标准化处理缺乏数据标准、数据收集所依据的研究设计不严谨、未严格把控RWD的适用性等,这些问题极大地影响RWD的质量。本文针对以上问题,提出加强对医疗机构中的RWD的管理、完善RWD的共享机制、RWS过程中应根据数据标准将RWD标准化、RWD的收集应依据严谨的研究设计、明确与RWD质量相关人员的职责、严格把控RWD的适用性6条建议,以期解决RWS中RWD存在的质量问题,为提升RWD质量提供参考。更多还原

【Abstract】 Traditional clinical trials that are randomized and controlled have exposed some deficiencies in the process of long-term use, prompting a growing number of researchers to look at real-world evidence(RWE). As an important basis of real-world study(RWS), real-world data(RWD) determine whether the RWS is qualified for supervision and review of institutions with reliable RWE. There are some problems about RWD, including unstructured and fragmented data, poor accessibility, lack of standards to standardize data, research design that is not rigorous, failure to control the applicability of RWD, etc. These problems will greatly affect the quality of RWD. Aiming to resolve the above problems, this paper provides six suggestions in order to provide a reference to improve the quality of RWD, including strengthening the management of RWD in medical institutions, improving RWD sharing mechanism, standardizing RWD according to data standards in RWS, collecting RWD according to rigorous research design, defining the responsibilities of personnel related to RWD quality and strictly controlling the applicability of RWD.更多还原