Abstract：
Real-world data (RWD) collected in routine health care processes and transformed to real-world evidence have become increasingly interesting within the research and medical communities to enhance medical research and support regulatory decision-making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which qualities RWD must meet in order to be acceptable for decision-making within regulatory or routine clinical decision support. In the absence of guidelines defining the quality standards for RWD, an overview and first recommendations for quality criteria for RWD in pharmaceutical research and health care decision-making is needed in Austria. An Austrian multistakeholder expert group led by Gesellschaft für Pharmazeutische Medizin (Austrian Society for Pharmaceutical Medicine) met regularly; reviewed and discussed guidelines, frameworks, use cases, or viewpoints; and agreed unanimously on a set of quality criteria for RWD. This consensus statement was derived from the quality criteria for RWD to be used more effectively for medical research purposes beyond the registry-based studies discussed in the European Medicines Agency guideline for registry-based studies. This paper summarizes the recommendations for the quality criteria of RWD, which represents a minimum set of requirements. In order to future-proof registry-based studies, RWD should follow high-quality standards and be subjected to the quality assurance measures needed to underpin data quality. Furthermore, specific RWD quality aspects for individual use cases (eg, medical or pharmacoeconomic research), market authorization processes, or postmarket authorization phases have yet to be elaborated.
摘要：
在常规医疗保健过程中收集并转化为现实世界证据的现实世界数据（RWD）在研究和医学界变得越来越有趣，以加强医学研究并支持监管决策。尽管有许多欧洲倡议，在监管或常规临床决策支持范围内,RWD必须满足哪些质量才能被决策所接受,目前尚无跨界共识或指南.在缺乏定义RWD质量标准的指南的情况下，奥地利需要对药物研究和医疗保健决策中RWD的质量标准进行概述和初步建议。由GesellschaftfürPharmazeutscheMedizin（奥地利药物医学学会）领导的奥地利多利益相关者专家组定期开会；审查并讨论了指南，框架，用例，或观点；并就RWD的一套质量标准达成一致。该共识声明源自RWD的质量标准，该质量标准将更有效地用于医学研究目的，而不是欧洲药品管理局关于基于注册的研究指南中讨论的基于注册的研究。本文总结了对RWD质量标准的建议，它表示一组最低要求。为了将来证明基于注册表的研究，RWD应遵循高质量标准，并接受支持数据质量所需的质量保证措施。此外，个别用例的特定RWD质量方面(例如，医学或药物经济学研究)，市场授权流程，或上市后授权阶段尚未详细说明。
