Decentralized Clinical Trials: Governance, Ethics and Medico-Legal Issues for the New Paradigm of Research with a...

The evolution of decentralized clinical trials, driven by advanced digital technologies, is transforming traditional clinical research. It introduces innovative methods for informed consent, remote patient monitoring, and data analysis, enhancing study efficiency, validity, and participation while reducing patient burden. Some clinical procedures can be conducted remotely, increasing trial accessibility and reducing population selection biases, particularly for cardiovascular patients. However, this also presents complex regulatory and ethical challenges. The article explores how digital platforms and emerging technologies like block chain, AI, and advanced cryptography can promote traceability, security, and transparency throughout the trial process, ensuring participant identification and documentation of each procedural step. Clear, legally compliant informed consent, often managed through electronic systems, both for research participation and data management in line with GDPR, is essential. Ethical considerations include ensuring participants understand trial information, with adaptations such as simplified language, visual aids, and multilingual support. The transnational nature of decentralized trials highlights the need for coordinated regulatory standards to overcome jurisdictional barriers and reinforce accountability. This framework promotes trust, shared responsibility, and the protection of participants rights while upholding high ethical standards in scientific research.