Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues.

Giuseppe Pasculli¹, Marco Virgolin², Puja Myles³, Anna Vidovszky⁴, Charles Fisher⁴, Elisabetta Biasin⁵, Miranda Mourby⁶, Francesco Pappalardo⁷, Saverio D'Amico^8,9, Mario Torchia¹, Alexander Chebykin², Vincenzo Carbone¹, Luca Emili¹, Daniel Roeshammar¹

¹InSilicoTrials Technologies S.p.A., Trieste, Italy.

²InSilicoTrials Technologies B.V., s-Hertogenbosch, the Netherlands.

³Medicines and Healthcare products Regulatory Agency, London, UK.

⁴Unlearn.AI, San Francisco, California, USA.

⁵Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium.

⁶Centre for Health, Law, and Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford, UK.

⁷Department of Drug and Health Sciences, University of Catania, Catania, Italy.

⁸Humanitas Clinical and Research Center-IRCCS, Milan, Italy.

⁹Train s.r.l., Milan, Italy.

PubMed PMC DOI PDF

Abstract

With the recent and evolving regulatory frameworks regarding the usage of Artificial Intelligence (AI) in both drug and medical device development, the differentiation between data derived from observed ('true' or 'real') sources and artificial data obtained using process-driven and/or (data-driven) algorithmic processes is emerging as a critical consideration in clinical research and regulatory d…

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