Article
Patient-centric Real-World Evidence research – an EU-wide Real4Reg survey on patients’ RWE knowledge, expectations and wishes
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Authors
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Martin Russek
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
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Frank Lucas Depner
- Deutsches Zentrum für Neurodegenerative Erkankungen e.V. (DZNE), Bonn, Germany
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Cornelia Becker
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
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Jonas Peltner
- Deutsches Zentrum für Neurodegenerative Erkankungen e.V. (DZNE), Bonn, Germany
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Kerstin Pfeifer
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
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Christoph Roethlein
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
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Britta Haenisch
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany; Deutsches Zentrum für Neurodegenerative Erkankungen e.V. (DZNE), Bonn, Germany; Rheinische Friedrich-Wilhelms-Universität Bonn, Zentrum für Translationale Medizin, Bonn, Germany
| Published: | September 6, 2024 |
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Outline
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Introduction: Real4Reg is a multinational EU-funded research project aiming to investigate and improve the utility of Real-World Data in supporting regulatory decision-making. The benefit of the patient is at the centre of pharmacoepidemiological research and regulation. Thus, it is crucial to incorporate patients’ views when considering new developments in the area of Real-World Evidence (RWE) research.
Through a survey to a wide range of European patient organizations, we aim to characterize those views, identify topics in need for improved education and communication, and approaches that need refinement.
Methods: Through a thorough stakeholder analysis, we identified EU-level patient organizations which we contacted to distribute our survey to their national member organizations and patient members. The survey is conducted via EUSurvey, the open-source online survey management tool of the European Commission, and contains 31 questions, structured into the domains knowledge, skills and interest in RWE. Responses are recorded anonymously.
Results: The survey closes in June 2024, the analysis will take place until August 2024. Preliminary results will be presented in September.
Conclusions: A better understanding of patients’ views around RWE will help regulators in making patient-centred evaluations, researchers in answering relevant questions, physicians in educating their patients in the area of RWE and the pharmaceutical industry in executing studies with a focus on patients’ preferences. Our results will thus advance patient-centred research in the area of pharmacoepidemiology and RWE.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.
