Decentralized Clinical Trials in Pediatrics: Is Italy Ready?

TL;DR

This paper explores whether Italy is prepared to conduct decentralized clinical trials in pediatrics, considering regulatory and technological changes.

Contribution

The study analyzes Italian regulations to assess the feasibility of decentralized clinical trials in pediatrics.

Findings

Italy has established guidelines to support decentralized clinical trials through regulatory simplification.

Decentralized trials could improve patient engagement and drug safety in pediatric research.

The feasibility of DCTs in Italy depends on alignment with European regulatory frameworks.

Abstract

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.