Development, optimisation and implementation of artificial intelligence methods for real world data analyses in regulatory decision-making and health technology assessment along the product lifecycle

Project Information

Real4Reg

Grant agreement ID: 101095353

DOI

10.3030/101095353

EC signature date 11 November 2022

Start date 1 January 2023

End date 31 December 2026

Funded under

• Health

Total cost

€ 6 999 425,00

EU contribution

€ 6 999 425,00

Coordinated by

BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE
Germany

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Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Websites, patent fillings, videos etc. (1)

Launch of public website

Other (1)

EU-PAS registration

Publications

Peer reviewed articles (4)

Key Stakeholders' Knowledge, Opinions, and Interests on Real‐World Evidence in the Regulatory Process—Results of an <scp>EU</scp> ‐Wide Survey

Author(s): Frank Lucas Depner, Martin Russek, Christoph Röthlein, Cornelia Becker, Jonas Peltner, Kerstin Pfeifer, Evy Reviers, Dirk De Valck, Julia Wicherski, Sirpa Hartikainen, Anna‐Maija Tolppanen, Britta Haenisch
Published in: Clinical and Translational Science, Issue 18, 2025, ISSN 1752-8054
Publisher: Wiley
DOI: 10.1111/CTS.70454

The EU project Real4Reg: unlocking real-world data with AI

Author(s): Jonas Peltner, Cornelia Becker, Julia Wicherski, Silja Wortberg, Mohamed Aborageh, Inês Costa, Vera Ehrenstein, Joana Fernandes, Steffen Heß, Erzsébet Horváth-Puhó, Monika Roberta Korcinska Handest, Manuel Lentzen, Peggy Maguire, Niels Henrik Meedom, Rebecca Moore, Vanessa Moore, Dávid Nagy, Hillary McNamara, Anne Paakinaho, Kerstin Pfeifer, Liisa Pylkkänen, Blair Rajamaki, Evy Reviers, Christoph Röthlein, Martin Russek, Célia Silva, Dirk De Valck, Thuan Vo, Elvira Bräuner, Holger Fröhlich, Cláudia Furtado, Sirpa Hartikainen, Aleksi Kallio, Anna-Maija Tolppanen, Britta Haenisch
Published in: Health Research Policy and Systems, Issue 23, 2025, ISSN 1478-4505
Publisher: Springer Science and Business Media LLC
DOI: 10.1186/S12961-025-01287-Y

Toward the Use of Real‐World Data for Regulatory and <scp>HTA</scp> Decision‐Making: Experiences and Recommendations from Six <scp>EU</scp> ‐Funded Projects

Author(s): Martin Russek, Jonas Peltner, Kerstin Pfeifer, Theodoros N. Arvanitis, Dirk De Valck, Sieta T. de Vries, Michel Dumontier, Vera Ehrenstein, Omaima El Hakouni, Gregory Epiphaniou, Gokhan Ertaylan, Joana Fernandes, Scott Hansen, Stuart Harrison, Erzsébet Horváth‐Puhó, Saif Ul Islam, Pekka Kahri, Julia K. Mader, Carsten Maple, Nikolaos Matragkas, Shivani Misra, Peter G.M. Mol, Anne Paakinaho, Sami Pakarinen, Martina Radanović, Evy Reviers, Kathrine Kold Sørensen, Marco Spruit, Christina Tikka, Anna‐Maija Tolppanen, Christian Torp‐Pedersen, Mirna Vela, Thuan Vo, Puriya Daniel Würtz Yazdanfard, Britta Haenisch
Published in: Clinical Pharmacology &amp; Therapeutics, 2026, ISSN 0009-9236
Publisher: Wiley
DOI: 10.1002/CPT.70502

Supplementing Single‐Arm Trials with External Control Arms—Evaluation of German Real‐World Data

Author(s): Martin Russek, Jonas Peltner, Britta Haenisch
Published in: Clinical Pharmacology &amp; Therapeutics, 2025, ISSN 0009-9236
Publisher: Wiley
DOI: 10.1002/CPT.3684