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| 001 | 277334 | ||
| 005 | 20250323000928.0 | ||
| 024 | 7 | _ | |a 10.1186/s12961-025-01287-y |2 doi |
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| 037 | _ | _ | |a DZNE-2025-00395 |
| 041 | _ | _ | |a English |
| 082 | _ | _ | |a 610 |
| 100 | 1 | _ | |a Peltner, Jonas |0 P:(DE-2719)9002192 |b 0 |e First author |u dzne |
| 245 | _ | _ | |a The EU project Real4Reg: unlocking real-world data with AI. |
| 260 | _ | _ | |a London |c 2025 |b BioMed Central |
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| 520 | _ | _ | |a The 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). |
| 536 | _ | _ | |a 354 - Disease Prevention and Healthy Aging (POF4-354) |0 G:(DE-HGF)POF4-354 |c POF4-354 |f POF IV |x 0 |
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| 650 | _ | 2 | |a Artificial Intelligence |2 MeSH |
| 650 | _ | 2 | |a European Union |2 MeSH |
| 650 | _ | 2 | |a Humans |2 MeSH |
| 650 | _ | 2 | |a Technology Assessment, Biomedical |2 MeSH |
| 650 | _ | 2 | |a Pharmacovigilance |2 MeSH |
| 650 | _ | 2 | |a Decision Making |2 MeSH |
| 650 | _ | 2 | |a Algorithms |2 MeSH |
| 700 | 1 | _ | |a Becker, Cornelia |0 P:(DE-2719)9000482 |b 1 |
| 700 | 1 | _ | |a Wicherski, Julia |0 P:(DE-2719)9000812 |b 2 |
| 700 | 1 | _ | |a Wortberg, Silja |b 3 |
| 700 | 1 | _ | |a Aborageh, Mohamed |b 4 |
| 700 | 1 | _ | |a Costa, Inês |b 5 |
| 700 | 1 | _ | |a Ehrenstein, Vera |b 6 |
| 700 | 1 | _ | |a Fernandes, Joana |b 7 |
| 700 | 1 | _ | |a Heß, Steffen |b 8 |
| 700 | 1 | _ | |a Horváth-Puhó, Erzsébet |b 9 |
| 700 | 1 | _ | |a Korcinska Handest, Monika Roberta |b 10 |
| 700 | 1 | _ | |a Lentzen, Manuel |b 11 |
| 700 | 1 | _ | |a Maguire, Peggy |b 12 |
| 700 | 1 | _ | |a Meedom, Niels Henrik |b 13 |
| 700 | 1 | _ | |a Moore, Rebecca |b 14 |
| 700 | 1 | _ | |a Moore, Vanessa |b 15 |
| 700 | 1 | _ | |a Nagy, Dávid |b 16 |
| 700 | 1 | _ | |a McNamara, Hillary |b 17 |
| 700 | 1 | _ | |a Paakinaho, Anne |b 18 |
| 700 | 1 | _ | |a Pfeifer, Kerstin |b 19 |
| 700 | 1 | _ | |a Pylkkänen, Liisa |b 20 |
| 700 | 1 | _ | |a Rajamaki, Blair |b 21 |
| 700 | 1 | _ | |a Reviers, Evy |b 22 |
| 700 | 1 | _ | |a Röthlein, Christoph |0 P:(DE-2719)2812311 |b 23 |
| 700 | 1 | _ | |a Russek, Martin |0 P:(DE-2719)9002837 |b 24 |u dzne |
| 700 | 1 | _ | |a Silva, Célia |b 25 |
| 700 | 1 | _ | |a De Valck, Dirk |b 26 |
| 700 | 1 | _ | |a Vo, Thuan |b 27 |
| 700 | 1 | _ | |a Bräuner, Elvira |b 28 |
| 700 | 1 | _ | |a Fröhlich, Holger |b 29 |
| 700 | 1 | _ | |a Furtado, Cláudia |b 30 |
| 700 | 1 | _ | |a Hartikainen, Sirpa |b 31 |
| 700 | 1 | _ | |a Kallio, Aleksi |b 32 |
| 700 | 1 | _ | |a Tolppanen, Anna-Maija |b 33 |
| 700 | 1 | _ | |a Haenisch, Britta |0 P:(DE-2719)2810511 |b 34 |e Last author |u dzne |
| 773 | _ | _ | |a 10.1186/s12961-025-01287-y |g Vol. 23, no. 1, p. 27 |0 PERI:(DE-600)2101196-5 |n 1 |p 27 |t Health research policy and systems |v 23 |y 2025 |x 1478-4505 |
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