%0期刊文章%@ 2291- 9694% I JMIR出版物%V 10卡塔尔世界杯8强波胆分析% N 6% P e34204 %T药物研究和医疗保健决策中真实数据的质量标准:奥地利专家共识%A Klimek,Peter %A波罗的海，Dejan %A Brunner,Martin %A degelseger - marquez,Alexander %A Garhöfer,Gerhard %A Gouya-Lechner,Ghazaleh %A Herzog,Arnold %A Jilma,Bernd %A Kähler,Stefan %A Mikl,Veronika %A Mraz,Bernhard %A Ostermann,Herwig %A Röhl,Claas %A Scharinger,Robert %A Stamm,Tanja %A Strassnig,Michael %A Wirthumer-Hoche,Christa %A Pleiner-Duxneuner,Johannes %A Gesellschaft, enelhorngasse 3，维也纳，1210，奥地利，43 1 40160 ext 36255，johannes.pleiner-duxneuner@roche.com % K真实数据% K真实证据% K数据质量% K数据质量标准% K RWD质量建议% K制药研究% K医疗决策% K医疗质量标准的RWD % K公司协会毛皮Pharmazeutische Medizin % K流量% D 2022% 7 17.6.2022 % 9视点% % G J JMIR通知英语% X (RWD)收集真实的数据在常规医疗流程和日益转化为现实世界的证据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. %M 35713954 %R 10.2196/34204 %U https://medinform.www.mybigtv.com/2022/6/e34204 %U https://doi.org/10.2196/34204 %U http://www.ncbi.nlm.nih.gov/pubmed/35713954