5 Essential Steps To Implementing Decentralized Clinical Trials In The EU And US

By Henk Dieteren, Clinical Supply Chain Solutions Consultant

When running decentralized clinical trials (DCTs) in both the US and Europe, it's crucial to understand the distinct regulatory perspectives of the FDA and the EMA on technology. While both agencies support the use of digital health technologies for remote data collection, their priorities differ. The FDA focuses on ensuring accessibility to prevent participant exclusion, requiring sponsors to provide alternatives for participants who may not have personal devices.

The EMA, however, takes a more cautious and neutral stance, emphasizing the rigorous validation of all digital tools and requiring contingency plans for technology failures. This means that to successfully run a global DCT, sponsors must create a comprehensive strategy that satisfies both frameworks. This involves designing protocols to meet the stricter EMA standards from the outset, addressing regional differences early in the planning phase, and maintaining meticulous documentation to demonstrate compliance. By engaging with regulators early and incorporating their feedback, you can design efficient trials that balance innovation with the regional requirements necessary for success.