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000277334 1001_ $$0P:(DE-2719)9002192$$aPeltner, Jonas$$b0$$eFirst author$$udzne
000277334 245__ $$aThe EU project Real4Reg: unlocking real-world data with AI.
000277334 260__ $$aLondon$$bBioMed Central$$c2025
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000277334 520__ $$aThe use of real-world data is established in post-authorization regulatory processes such as pharmacovigilance of drugs and medical devices, but is still frequently challenged in the pre-authorization phase of medicinal products. In addition, the use of real-world data, even in post-authorization steps, is constrained by the availability and heterogeneity of real-world data and by challenges in analysing data from different settings and sources. Moreover, there are emerging opportunities in the use of artificial intelligence in healthcare research, but also a lack of knowledge on its appropriate application to heterogeneous real-world data sources to increase evidentiary value in the regulatory decision-making and health technology assessment context.The Real4Reg project aims to enable the use of real-world data by developing user-friendly solutions for the data analytical needs of health regulatory and health technology assessment bodies across the European Union. These include artificial intelligence algorithms for the effective analysis of real-world data in regulatory decision-making and health technology assessment. The project aims to investigate the value of real-world data from different sources to generate high-quality, accessible, population-based information relevant along the product life cycle. A total of four use cases are used to provide good practice examples for analyses of real-world data for the evaluation and pre-authorization stage, the improvement of methods for external validity in observational data, for post-authorization safety studies and comparative effectiveness using real-world data. This position paper introduces the objectives and structure of the Real4Reg project and discusses its important role in the context of existing European projects focussing on real-world data.Real4Reg focusses on the identification and description of benefits and risks of new and optimized methods in real-world data analysis including aspects of safety, effectiveness, interoperability, appropriateness, accessibility, comparative value creation and sustainability. The project's results will support better decision-making about medicines and benefit patients' health. Trial registration Real4Reg is registered in the HMA-EMA Catalogues of real-world data sources and studies (EU PAS number EUPAS105544).
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000277334 650_2 $$2MeSH$$aArtificial Intelligence
000277334 650_2 $$2MeSH$$aEuropean Union
000277334 650_2 $$2MeSH$$aHumans
000277334 650_2 $$2MeSH$$aTechnology Assessment, Biomedical
000277334 650_2 $$2MeSH$$aPharmacovigilance
000277334 650_2 $$2MeSH$$aDecision Making
000277334 650_2 $$2MeSH$$aAlgorithms
000277334 7001_ $$0P:(DE-2719)9000482$$aBecker, Cornelia$$b1
000277334 7001_ $$0P:(DE-2719)9000812$$aWicherski, Julia$$b2
000277334 7001_ $$aWortberg, Silja$$b3
000277334 7001_ $$aAborageh, Mohamed$$b4
000277334 7001_ $$aCosta, Inês$$b5
000277334 7001_ $$aEhrenstein, Vera$$b6
000277334 7001_ $$aFernandes, Joana$$b7
000277334 7001_ $$aHeß, Steffen$$b8
000277334 7001_ $$aHorváth-Puhó, Erzsébet$$b9
000277334 7001_ $$aKorcinska Handest, Monika Roberta$$b10
000277334 7001_ $$aLentzen, Manuel$$b11
000277334 7001_ $$aMaguire, Peggy$$b12
000277334 7001_ $$aMeedom, Niels Henrik$$b13
000277334 7001_ $$aMoore, Rebecca$$b14
000277334 7001_ $$aMoore, Vanessa$$b15
000277334 7001_ $$aNagy, Dávid$$b16
000277334 7001_ $$aMcNamara, Hillary$$b17
000277334 7001_ $$aPaakinaho, Anne$$b18
000277334 7001_ $$aPfeifer, Kerstin$$b19
000277334 7001_ $$aPylkkänen, Liisa$$b20
000277334 7001_ $$aRajamaki, Blair$$b21
000277334 7001_ $$aReviers, Evy$$b22
000277334 7001_ $$0P:(DE-2719)2812311$$aRöthlein, Christoph$$b23
000277334 7001_ $$0P:(DE-2719)9002837$$aRussek, Martin$$b24$$udzne
000277334 7001_ $$aSilva, Célia$$b25
000277334 7001_ $$aDe Valck, Dirk$$b26
000277334 7001_ $$aVo, Thuan$$b27
000277334 7001_ $$aBräuner, Elvira$$b28
000277334 7001_ $$aFröhlich, Holger$$b29
000277334 7001_ $$aFurtado, Cláudia$$b30
000277334 7001_ $$aHartikainen, Sirpa$$b31
000277334 7001_ $$aKallio, Aleksi$$b32
000277334 7001_ $$aTolppanen, Anna-Maija$$b33
000277334 7001_ $$0P:(DE-2719)2810511$$aHaenisch, Britta$$b34$$eLast author$$udzne
000277334 773__ $$0PERI:(DE-600)2101196-5$$a10.1186/s12961-025-01287-y$$gVol. 23, no. 1, p. 27$$n1$$p27$$tHealth research policy and systems$$v23$$x1478-4505$$y2025
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