Artikel
Real-World Evidence (RWE) in the medicines regulatory process – an EU-wide Real4Reg survey on key stakeholders’ RWE knowledge, opinions and interests
Suche in Medline nach
Autoren
-
Martin Russek
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
-
Frank Lucas Depner
- Deutsches Zentrum für Neurodegenerative Erkankungen e.V. (DZNE), Bonn, Germany
-
Cornelia Becker
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
-
Jonas Peltner
- Deutsches Zentrum für Neurodegenerative Erkankungen e.V. (DZNE), Bonn, Germany
-
Kerstin Pfeifer
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
-
Christoph Roethlein
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
-
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
| Veröffentlicht: | 6. September 2024 |
|---|
Gliederung
Text
Introduction: Real4Reg is a multinational EU-funded research project aiming to investigate and improve the utility of Real-World Data (RWD) in supporting regulatory decision-making. To support and facilitate the widespread adoption of RWD/RWE usage in medicines regulation and HTA, we are developing standards for RWD/RWE use, including artificial intelligence (AI) and machine learning (ML) tools to manage, analyse, and interpret this data.
Well-executed research within medicines regulation takes into account the views of all relevant stakeholders to enable optimal applicability and usage of scientific results. To achieve this, we launched a survey to relevant stakeholders to gather their insights and opinions around the use of RWE and AI/ML learning methodology in medicines regulation.
Methods: Through a thorough stakeholder analysis, we identified a large number of stakeholders in the medicines regulatory process. Using EUSurvey, the open-source online survey management tool of the European Commission, we created three surveys tailored to i) Pharmaceutical industry and Regulatory/HTA bodies, ii) Academia and iii) Payers. The surveys contain between 38 and 42 questions, which are structured into the domains of knowledge, opinions, current usage and interest in RWE and AI/ML methodology. 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: Successful pharmacoepidemiological research takes into account the knowledge and experiences from a wide range of stakeholders. The results of our surveys will help researchers to develop targeted training in RWE and AI/ML usage, relevant methodology and studies with practical relevance to many involved stakeholders.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.
