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[德国卫生服务研究网络(DNVF)关于根据社会法典第五卷进行与应用相关的数据收集的立场文件]

[Position paper of the German Network for Health Services Research (DNVF) on application-related data collection according to Social Code Book V].

作者信息

Niemeyer Anna, Kluge Sandra, Gurisch Carolin, Hoffmann Wolfgang, Kostuj Tanja, Olbrich Kerstin, Rau Henriette, Rauchensteiner Stephan, Stausberg Jürgen

机构信息

BQS Institut, Hamburg.

TMF e. V., Berlin.

出版信息

Gesundheitswesen. 2021 Apr;83(4):309-313. doi: 10.1055/a-1391-3908. Epub 2021 Apr 8.

Abstract

Within the framework of the early benefit assessment, the Federal Joint Committee (G-BA) has been authorised since 2019 by the law for more safety in the supply of pharmaceuticals GSAV to request additional application-related data capture for certain pharmaceutical drugs. This results in certain challenges, especially in the area of conflict between methodological requirements and practical feasibility. The position paper provides an overview and takes up the general regulations defined by the Federal Ministry of Health (BMG) as well as the process defined by the G-BA. Subsequently, possible solutions are discussed and recommendations for implementation are given from the perspective of health care research.

摘要

在早期效益评估框架内,自2019年起,联邦联合委员会(G-BA)依据《药品供应安全加强法》(GSAV)被授权要求针对某些药品进行额外的与申请相关的数据采集。这带来了一定挑战,尤其是在方法学要求与实际可行性之间的冲突领域。本立场文件提供了概述,并阐述了联邦卫生部(BMG)规定的一般规则以及G-BA规定的流程。随后,讨论了可能的解决方案,并从医疗保健研究的角度给出了实施建议。

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