ArticleJMIR medical informatics2022
Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus.
Article in JMIR medical informatics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making.Scientific reports · 2024Article
- Expert survey on real-world data utilization and real-world evidence generation for regulatory decision-making in drug lifecycle in Korea.Clinical and translational science · 2024Article
- The Agreement between Consumer-Driven Self-Assessment of Psoriasis Severity and Physician-Assessed Severity Based on Patient-Taken Photographs Is Weak: A Cross-Sectional Study.Dermatology (Basel, Switzerland) · 2024Article
- The impact of data quality monitoring of a multicenter prospective registry of cardiac implantable electronic devices.MethodsX · 2023Article
- Overcoming personal information protection challenges involving real-world data to support public health efforts in China.Frontiers in public health · 2023Article
- Quality of real-world registry studies.Perspectives in clinical researchArticle
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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