Bourla Ariel B, Meropol Neal J
Flatiron Health, Inc., New York, NY, USA.
Digit Health. 2021 Nov 25;7:20552076211059975. doi: 10.1177/20552076211059975. eCollection 2021 Jan-Dec.
Real world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources; real-world evidence (RWE) generated by RWD analyses can become an important component of drug development programs and, potentially, regulatory decision-making. As a RWD source, electronic health records (EHRs) can now provide patient-level data at unparalleled depth and granularity. We propose a RWE generation framework that could maximize the synergy between RWD and prospective clinical trials by capitalizing on an emerging data curation infrastructure that may be applied to both retrospective and prospective research. In this platform, centralized data collection and monitoring could be enabled via routine EHR use, and seamlessly integrated with select intentional data capture during prospective study periods. By bridging the divide between routine care and clinical research, this integrated platform aggregates retrospective and prospective data, collected both routinely and intentionally. This approach makes clinical trial participation more available to patients, increasing the potential depth of data, representativeness and efficiency of clinical research.
真实世界数据（RWD）是指与患者健康状况和/或医疗保健服务相关的数据，这些数据通常从各种来源收集；通过对RWD进行分析而产生的真实世界证据（RWE）可以成为药物研发项目的重要组成部分，并有可能用于监管决策。作为一种RWD来源，电子健康记录（EHR）现在可以以前所未有的深度和粒度提供患者层面的数据。我们提出了一个RWE生成框架，该框架可以通过利用一种新兴的数据管理基础设施，最大限度地发挥RWD与前瞻性临床试验之间的协同作用，这种基础设施可应用于回顾性研究和前瞻性研究。在这个平台上，可以通过常规使用EHR实现集中数据收集和监测，并在前瞻性研究期间与选定的有意数据捕获无缝集成。通过弥合常规护理与临床研究之间的差距，这个集成平台汇总了通过常规和有意方式收集的回顾性和前瞻性数据。这种方法使患者更容易参与临床试验，增加了数据的潜在深度、临床研究的代表性和效率。
