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Reviews on Recent Clinical Trials

Editor-in-Chief

ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Mini-Review Article

Clinical Trials and Machine Learning: Regulatory Approach Review

Author(s): Diego Alejandro Dri*, Maurizio Massella, Donatella Gramaglia, Carlotta Marianecci and Sandra Petraglia

Volume 16, Issue 4, 2021

Published on: 15 July, 2021

Page: [341 - 350] Pages: 10

DOI: 10.2174/1574887116666210715114203

Price: $65

Abstract

Machine Learning, a fast-growing technology, is an application of Artificial Intelligence that has provided important contributes to drug discovery and clinical development. In the last few years, the number of clinical applications based on Machine Learning has been constantly growing and this is now affecting the National Competent Authorities during the assessment of most recently submitted Clinical Trials that are designed, managed or that are generating data deriving from the use of Machine Learning or Artificial Intelligence technologies. We review current information available on the regulatory approach to Clinical Trials and Machine Learning. We also provide inputs for further reasoning and potential indications, including six actionable proposals for regulators to proactively drive the upcoming evolution of Clinical Trials within a strong regulatory framework, focusing on patient’s safety, health protection and fostering immediate access to effective treatments.

Keywords: Artificial intelligence, big data, clinical trials, digital medicine, drug discovery, machine learning, regulatory.

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