Understanding Decentralized Clinical Trials: FDA vs. EMA Fundamentals

By Henk Dieteren, Clinical Supply Chain Solutions Consultant

When designing decentralized clinical trials (DCTs), it's essential to understand the different approaches taken by the FDA and the EMA. While both agencies support decentralized elements to make trials more accessible, their definitions and expectations differ. Both agencies permit fully decentralized trials; however, the EMA tends to favor hybrid models that still include an option for site visits. This contrast is particularly evident in the informed consent process.

The FDA allows electronic informed consent, while the EMA recommends face-to-face communication, especially for critical discussions, and requires a detailed workflow of the consent process in the clinical trial application. These differences, along with others, have significant implications for global trial protocols, requiring sponsors to design a single, comprehensive strategy that can satisfy the stricter requirements of both regulatory bodies. Addressing these variations early in the planning process can prevent costly delays and ensure compliance.