Regulatory Landscape

This chapter reviews the regulatory journey of decentralized clinical trials (DCTs) leading up to and during the COVID-19 pandemic. Pre-pandemic milestones, including the 21st Century Cures Act and regulatory acts of 2022, paved the way for advancements in healthcare inclusivity, diversity, and technological innovation. Amid the pandemic, disruptions to traditional trials prompted the swift adoption of decentralized approaches. Emergency guidance from health authorities, including the FDA, addressed challenges, leading to a shift in trial activities from in-person to virtual settings. The FDA’s Technology Modernization Action Plan in 2019 set the groundwork for post-pandemic regulatory developments. Subsequent guidance, including the highly anticipated DCT draft in May 2023, defined DCTs, emphasized diversity, and encouraged innovative trial designs. This chapter explores the FDA’s draft guidance, outlining core DCT elements, design considerations, investigator responsibilities, and product considerations.