Insights from the European Medicines Agency on digital health technology derived endpoints

Abstract

This study evaluates the use of digital health technologies (DHTs) for endpoint measurement in clinical trials, as documented in the Qualification Opinions, Qualification Advice, and Scientific Advice procedures issued by the European Medicines Agency (EMA) between 2013 and 2022. Accelerometers are the most proposed DHTs, followed by glucose monitors and smartphones. Accelerometers are often proposed for nervous system diseases to support mobility measures and objective testing. Most DHTs were proposed for efficacy endpoints. The feedback provided by EMA emphasizes the importance of validation, precision, and a clearly defined context of use. The EMA's recent action plan further supports advancing DHT methodologies in clinical trials.