真实世界数据(RWD)可以提供英特尔(真实世界的证据,RWE)用于研究和开发,以及整个医疗保健领域的政策和监管决策。尽管全球监管机构呼吁开展国际合作,将RWE纳入监管决策并弥合知识差距,一些挑战依然存在。在这项工作中,我们使用多边查询方法对奥地利RWD来源进行了评估,对照先前公布的RWD标准进行交叉检查,并对代表性的RWD来源样本进行了直接访谈。本文概述了国家立法环境中104个RWD来源中的73个,在这些立法环境中,进行了重大尝试以实现RWD的二次使用(例如,研究组织法,\“Forschungsorganizationsgesetz\”)。我们能够检测到与数据孤岛相关的无所不在的挑战,变量标准化工作和治理问题。我们的研究结果表明,迫切需要国家卫生数据战略和数据治理框架,这应该告诉研究人员,以及政策制定者和决策者,改善医疗保健部门基于RWD的研究,以最终支持实际的监管决策,并为政府健康数据政策提供战略信息。
Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care. Despite calls from global regulators for international collaborations to integrate RWE into regulatory decision-making and to bridge knowledge gaps, some challenges remain. In this work, we performed an evaluation of Austrian RWD sources using a multilateral query approach, crosschecked against previously published RWD criteria and conducted direct interviews with representative RWD source samples. This article provides an overview of 73 out of 104 RWD sources in a national legislative setting where major attempts are made to enable secondary use of RWD (e.g. law on the organisation of research, \"Forschungsorganisationsgesetz\"). We were able to detect omnipresent challenges associated with data silos, variable standardisation efforts and governance issues. Our findings suggest a strong need for a national health data strategy and data governance framework, which should inform researchers, as well as policy- and decision-makers, to improve RWD-based research in the healthcare sector to ultimately support actual regulatory decision-making and provide strategic information for governmental health data policies.