Technology Landscape and Requirements

In decentralized clinical trials (DCTs), managing the flow of data between various systems becomes crucial. This chapter explores the Findable, Accessible, Interoperable, and Reusable (FAIR) data principles, health data interoperability in the United States, and efforts to harmonize adoption and regulatory standards, including the Health Insurance Portability and Accountability Act (HIPAA) and the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice. It highlights technology implementation considerations in clinical trials, addressing legal data privacy, regulatory compliance, system compatibility, user experience, reliability, accuracy, data integration, scalability, and cost-effectiveness. Future trends in DCTs include linking EHRs, utilizing digital health technology (DHT) measurements as endpoints, leveraging artificial intelligence (AI) and machine learning (ML), and expanding the “Digiverse”—the digital universe of solutions tailored for each DCT. These trends aim to enhance trial efficiency, data quality, and participant experience in the evolving clinical research landscape.