3 Themes And Takeaways From FDA's Draft Guidance On DCTs

By Bill Byrom, PhD, Principal, eCOA Science, Signant Health; and Anthony T. Everhart, MD, Clinical Vice President, Internal Medicine

In May of 2023, the U.S. Food and Drug Administration (FDA) unveiled a draft guidance document titled "Decentralized Clinical Trials for Drugs, Biological Products, and Devices".¹ Offering a glimpse into the FDA's stance regarding the incorporation of decentralized elements and fully decentralized trials, the guidance is noted to have gained even more significance in light of the European Medicines Agency's (EMA) recommendation paper on decentralized elements.²

Within the realm of their draft guidance, which is open for public feedback for a span of 90 days, the FDA meticulously defines a decentralized clinical trial (DCT) as, "a clinical trial wherein some or all trial-related activities transpire at locations beyond the conventional clinical trial sites." Additionally, the term "hybrid DCT" is introduced to characterize trials that blend in-person site visits with activities conducted at alternative locations, such as participants' residences.

Within this white paper, Signant's team of clinical science and trial optimization experts present a concise overview of the pivotal themes encapsulated within the guidance. Furthermore, they provide their valuable perspective on the matter.

Dive into the white paper to gain insights into:

• The various applications of technology in DCTs
• Critical considerations for maintaining investigator oversight
• Strategies for upholding data precision and integrity