Kyle Faget and Alexandra Maulden Comment on New FDA Guidance on Decentralized Trials

Foley & Lardner LLP Partner and Health Care Practice Group Co-Chair Kyle Faget and Associate Alexandra Maulden are quoted in the anju article, “The FDA’s Newest Guidance on Decentralized Trials: 5 Things to Know,” offering their insight on what clinical researchers should look for following the FDA’s new guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices.

“Look for a digital health technologies (DHT) steering committee to “help coordinate different working groups across the Centers and make policy recommendations impacting the use of DHT-based measurements in clinical drug trials,” Faget and Maulden explained.

They added that the FDA also plans “to upgrade its technical expertise and training, leverage its statistical expertise to analyze endpoints derived from DHT data, and upgrade its IT capabilities to allow for large-scale analysis of DHT-generated data.”