Bowman Louise, Baras Aris, Bombien René, Califf Robert M, Chen Zhengmin, Gale Chris P, Gaziano J Michael, Grobbee Diederick E, Maggioni Aldo P, Muse Evan D, Roden Dan M, Schroeder Stefan, Wallentin Lars, Casadei Barbara
Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Regeneron Pharmaceuticals, Tarrytown, NY, USA.
Eur Heart J. 2020 Jul 14;41(27):2571-2578. doi: 10.1093/eurheartj/ehaa020.
The availability of large datasets from multiple sources [e.g. registries, biobanks, electronic health records (EHRs), claims or billing databases, implantable devices, wearable sensors, and mobile apps], coupled with advances in computing and analytic technologies, have provided new opportunities for conducting innovative health research. Equally, improved digital access to health information has facilitated the conduct of efficient randomized controlled trials (RCTs) upon which clinical management decisions can be based, for instance, by permitting the identification of eligible patients for recruitment and/or linkage for follow-up via their EHRs. Given these advances in cardiovascular data science and the complexities they behold, it is important that health professionals have clarity on the appropriate use and interpretation of observational, so-called 'real-world', and randomized data in cardiovascular medicine. The Cardiovascular Roundtable of the European Society of Cardiology (ESC) held a workshop to explore the future of RCTs and the current and emerging opportunities for gathering and exploiting complex observational datasets in cardiovascular research. The aim of this article is to provide a perspective on the appropriate use of randomized and observational data and to outline the ESC plans for supporting the collection and availability of clinical data to monitor and improve the quality of care of patients with cardiovascular disease in Europe and provide an infrastructure for undertaking pragmatic RCTs. Moreover, the ESC continues to campaign for greater engagement amongst regulators, industry, patients, and health professionals in the development and application of a more efficient regulatory framework that is able to take maximal advantage of new opportunities for improving the design and efficiency of observational studies and RCT in patients with cardiovascular disease.
来自多个来源的大型数据集（例如登记处、生物样本库、电子健康记录（EHR）、理赔或计费数据库、可植入设备、可穿戴传感器和移动应用程序）的可用性，再加上计算和分析技术的进步，为开展创新性健康研究提供了新机遇。同样，改善对健康信息的数字访问，有助于开展高效的随机对照试验（RCT），临床管理决策可基于这些试验做出，例如，通过电子健康记录识别符合招募条件的患者和/或进行随访关联。鉴于心血管数据科学的这些进展及其带来的复杂性，健康专业人员清楚心血管医学中观察性（即所谓“真实世界”）数据和随机数据的恰当使用及解读非常重要。欧洲心脏病学会（ESC）心血管圆桌会议举办了一次研讨会，探讨随机对照试验的未来以及心血管研究中收集和利用复杂观察性数据集的当前及新出现的机遇。本文旨在就随机数据和观察性数据的恰当使用提供一个观点，并概述ESC支持收集和提供临床数据以监测和改善欧洲心血管疾病患者护理质量并为开展务实随机对照试验提供基础设施的计划。此外，ESC继续倡导监管机构、行业、患者和健康专业人员更多地参与制定和应用更高效的监管框架，该框架能够最大程度地利用新机遇来改善心血管疾病患者观察性研究和随机对照试验的设计及效率。
