This review outlines how decentralized clinical trials, supported by advanced digital technologies, are redefining traditional research processes by enabling remote informed consent, virtual monitoring, and more efficient data analysis. These innovations improve study validity, reduce patient burden, and expand access—particularly for cardiovascular patients—by allowing certain procedures to be performed outside clinical sites. At the same time, the integration of digital platforms, blockchain, AI, and advanced cryptography enhances traceability, security, and procedural transparency throughout the trial lifecycle.
Despite these benefits, decentralized trials introduce important regulatory and ethical challenges that require structured oversight. The article emphasizes that electronic informed consent must be legally compliant, GDPR-aligned, and accessible through simplified language, visual tools, and multilingual support. It further highlights the necessity of harmonized cross-border regulatory standards to address jurisdictional differences, ensuring consistent participant protection. Overall, these frameworks strengthen trust and shared responsibility while supporting high ethical standards in modern scientific research.
Keywords: decentralized clinical trials, informed consent, digital health technologies, regulatory ethics
Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC12551035/