Abstract
The role of artificial intelligence and machine learning in clinical trials is reviewed and analyzed, navigating through progresses over the years in such a fast evolving field. The current regulatory environment is explored and the application of artificial intelligence and machine learning in clinical trials is investigated focusing on those fields that may be impacted by the use of new technology and, with a dedicated glance at the data lifecycle. Key information and potential issues connected to the application of laws and regulation in a clinical trial and artificial intelligence setting are highlighted with the objective to support the identification of specific requirements and additional information needed for clinical trials based on artificial intelligence or machine learning use and, to provide recommendations for regulators and stakeholders involved in the medicinal products lifecycle.
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