This analysis explores decentralized clinical trials in pediatrics, focusing on regulatory implications and participant engagement.
Driven by technological advances and regulatory developments, the clinical trials industry is undergoing a period of transformation. Decentralized clinical trials (DCTs) promise to streamline processes, increase participant engagement and improve data quality. The pediatric clinical trial landscape is challenging, as participation in a clinical trial affects the whole family. DCTs allow for increased patient engagement, thereby improving trial quality and consequently drug safety. The Italian Medicines Agency (AIFA), in its quest for regulatory simplification and alignment with the European framework, has established comprehensive guidelines to facilitate these decentralized trials. The present work aims to delve into the regulations to understand the feasibility of conducting decentralized pediatric trials in Italy.
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Paternuosto et al. (2025) studied this question.
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