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

Journal: Health research policy and systems
PMID: 40016823

Abstract

BACKGROUND: 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.

Authors

  • Jonas Peltner
    German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.
  • Cornelia Becker
    Research Division, Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
  • Julia Wicherski
    Research Division, Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
  • Silja Wortberg
    Research Division, Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
  • Mohamed Aborageh
    Department of Bioinformatics, Fraunhofer Institute for Algorithms and Scientific Computing (SCAI), Sankt Augustin, Germany.
  • Inês Costa
    INFARMED, National Authority of Medicines and Health Products, I.P., Health Technology Assessment Department (DATS), Lisbon, Portugal.
  • Vera Ehrenstein
    Department of Clinical Medicine, Department of Clinical Epidemiology, and Center for Population Medicine, Aarhus University, Aarhus, Denmark.
  • Joana Fernandes
    Faculty of Engineering of the University of Porto, Porto, Portugal.
  • Steffen Heß
    Health Data Lab (FDZ), Federal Institute for Drugs and Medical Devices, Bonn, Germany.
  • Erzsébet Horváth-Puhó
    Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
  • Monika Roberta Korcinska Handest
    Data Analytics Center, Danish Medicines Agency, Copenhagen, Denmark.
  • Manuel Lentzen
    Department of Bioinformatics, Fraunhofer Institute for Algorithms and Scientific Computing (SCAI), Schloss Birlinghoven, Sankt Augustin, 53757, Germany.
  • Peggy Maguire
    European Institute for Women's Health (EIWH), Dublin, Ireland.
  • Niels Henrik Meedom
    Data Analytics Center, Danish Medicines Agency, Copenhagen, Denmark.
  • Rebecca Moore
    European Institute for Women's Health (EIWH), Dublin, Ireland.
  • Vanessa Moore
    European Institute for Women's Health (EIWH), Dublin, Ireland.
  • Dávid Nagy
    Department of Clinical Medicine, Department of Clinical Epidemiology, and Center for Population Medicine, Aarhus University, Aarhus, Denmark.
  • Hillary McNamara
    European Institute for Women's Health (EIWH), Dublin, Ireland.
  • Anne Paakinaho
    School of Pharmacy, University of Eastern Finland, Kuopio, Finland.
  • Kerstin Pfeifer
    Research Division, Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
  • Liisa Pylkkänen
    Department of Oncology, University of Turku, Turku, Finland.
  • Blair Rajamaki
    School of Pharmacy, University of Eastern Finland, Kuopio, Finland.
  • Evy Reviers
    European Association for Professionals and People with ALS (EUpALS), Louvain, Belgium.
  • Christoph Röthlein
    Research Division, Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
  • Martin Russek
    Research Division, Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
  • Célia Silva
    INFARMED, National Authority of Medicines and Health Products, I.P., Information and Strategic Planning Department (DIPE), Lisbon, Portugal.
  • Dirk De Valck
    European Association for Professionals and People with ALS (EUpALS), Louvain, Belgium.
  • Thuan Vo
    School of Pharmacy, University of Eastern Finland, Kuopio, Finland.
  • Elvira Bräuner
    Data Analytics Center, Danish Medicines Agency, Copenhagen, Denmark.
  • Holger Fröhlich
    Department of Bioinformatics, Fraunhofer Institute for Algorithms and Scientific Computing (SCAI), Sankt Augustin 53757, Germany.
  • Cláudia Furtado
    INFARMED, National Authority of Medicines and Health Products, I.P., Information and Strategic Planning Department (DIPE), Lisbon, Portugal.
  • Sirpa Hartikainen
    Kuopio Research Center of Geriatric Care, School of Pharmacy, University of Eastern Finland, Kuopio, Finland.
  • Aleksi Kallio
    CSC-IT Center for Science Ltd., Espoo, Finland.
  • Anna-Maija Tolppanen
    Kuopio Research Center of Geriatric Care, School of Pharmacy, University of Eastern Finland, Kuopio, Finland. Electronic address: anna-maija.tolppanen@uef.fi.
  • Britta Haenisch
    German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany. britta.haenisch@bfarm.de.

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