The Spanish Agency of Medicines and Medical Devices (AEMPS) has published the Guide for the Implementation of Decentralized Elements in Clinical Trials. This document, created by a multidisciplinary group coordinated by the AEMPS, addresses the increasing use of digital tools in clinical trials. It also complements the European 2022 guide, tackling aspects that were open to interpretation depending on the legislation of each member state. Both guides aim to provide clear recommendations for procedures carried out outside trial centers, ensuring data reliability and facilitating regulatory decision-making.
Decentralized clinical trials (DCTs) bring studies closer to patients through technologies such as telemedicine, virtual recruitment, electronic consent, and mobile nursing. This model helps involve people facing barriers such as distance, limited mobility, or lack of availability to travel.
During the COVID-19 pandemic, ScienHub successfully implemented home-based CTUs, adapting to patients’ needs. We continue to offer these solutions today to ensure the continuity of trials.
The document will be officially presented during the first quarter of 2025 in a discussion held at the AEMPS headquarters. The event will also be available for streaming.