Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus
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 initiative...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-06-01
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| Series: | JMIR Medical Informatics |
| Online Access: | https://medinform.jmir.org/2022/6/e34204 |
| _version_ | 1827858216932868096 |
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| author | Peter Klimek Dejan Baltic Martin Brunner Alexander Degelsegger-Marquez Gerhard Garhöfer Ghazaleh Gouya-Lechner Arnold Herzog Bernd Jilma Stefan Kähler Veronika Mikl Bernhard Mraz Herwig Ostermann Claas Röhl Robert Scharinger Tanja Stamm Michael Strassnig Christa Wirthumer-Hoche Johannes Pleiner-Duxneuner |
| author_facet | Peter Klimek Dejan Baltic Martin Brunner Alexander Degelsegger-Marquez Gerhard Garhöfer Ghazaleh Gouya-Lechner Arnold Herzog Bernd Jilma Stefan Kähler Veronika Mikl Bernhard Mraz Herwig Ostermann Claas Röhl Robert Scharinger Tanja Stamm Michael Strassnig Christa Wirthumer-Hoche Johannes Pleiner-Duxneuner |
| author_sort | Peter Klimek |
| collection | DOAJ |
| description |
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. |
| first_indexed | 2024-03-12T12:51:49Z |
| format | Article |
| id | doaj.art-856c101185414892ab90546a07af2177 |
| institution | Directory Open Access Journal |
| issn | 2291-9694 |
| language | English |
| last_indexed | 2024-03-12T12:51:49Z |
| publishDate | 2022-06-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Medical Informatics |
| spelling | doaj.art-856c101185414892ab90546a07af21772023-08-28T22:19:12ZengJMIR PublicationsJMIR Medical Informatics2291-96942022-06-01106e3420410.2196/34204Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert ConsensusPeter Klimekhttps://orcid.org/0000-0003-1187-6713Dejan Baltichttps://orcid.org/0000-0001-9855-8464Martin Brunnerhttps://orcid.org/0000-0002-6922-7559Alexander Degelsegger-Marquezhttps://orcid.org/0000-0002-0493-4711Gerhard Garhöferhttps://orcid.org/0000-0001-5547-5669Ghazaleh Gouya-Lechnerhttps://orcid.org/0000-0002-6320-8015Arnold Herzoghttps://orcid.org/0000-0003-3845-7674Bernd Jilmahttps://orcid.org/0000-0001-5652-7977Stefan Kählerhttps://orcid.org/0000-0002-5142-1265Veronika Miklhttps://orcid.org/0000-0002-3168-691XBernhard Mrazhttps://orcid.org/0000-0002-9166-3605Herwig Ostermannhttps://orcid.org/0000-0003-1412-658XClaas Röhlhttps://orcid.org/0000-0003-0320-9435Robert Scharingerhttps://orcid.org/0000-0002-2907-3575Tanja Stammhttps://orcid.org/0000-0003-3073-7284Michael Strassnighttps://orcid.org/0000-0003-1395-0868Christa Wirthumer-Hochehttps://orcid.org/0000-0002-9583-4985Johannes Pleiner-Duxneunerhttps://orcid.org/0000-0002-3492-846X 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.https://medinform.jmir.org/2022/6/e34204 |
| spellingShingle | Peter Klimek Dejan Baltic Martin Brunner Alexander Degelsegger-Marquez Gerhard Garhöfer Ghazaleh Gouya-Lechner Arnold Herzog Bernd Jilma Stefan Kähler Veronika Mikl Bernhard Mraz Herwig Ostermann Claas Röhl Robert Scharinger Tanja Stamm Michael Strassnig Christa Wirthumer-Hoche Johannes Pleiner-Duxneuner Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus JMIR Medical Informatics |
| title | Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus |
| title_full | Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus |
| title_fullStr | Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus |
| title_full_unstemmed | Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus |
| title_short | Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus |
| title_sort | quality criteria for real world data in pharmaceutical research and health care decision making austrian expert consensus |
| url | https://medinform.jmir.org/2022/6/e34204 |
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