REGULATORY FRAMEWORKS FOR DECENTRALIZED CLINICAL TRIALS: A COMPARATIVE ANALYSIS OF FDA AND EMA GUIDELINES

Decentralized clinical trials (DCTs) have taken the landscape of clinical research significantly further by exploiting digital technologies, remote monitoring, and telemedicine for patient involvement and data-pulling. However, the governing regulatory frameworks that exist for DCTs vary from region to region, with the U.S. Food and Drug Administration and the European Medicines Agency establishing different sets of guidelines to ensure patient safety, data integrity, and compliance. This review serves to provide a comparative analysis of the regulations set by the FDA and EMA when it comes to DCTs in the following subject areas: remote patient monitoring, eConsent, data protection (HIPAA vs. GDPR), and the artificial intelligence role in overseeing the trial activity. Significant differences, therefore, would also include regulatory flexibility, ethics committee involvement, and data security requirements.