Entities involved in developing and validating digital endpoints for use in clinical trials will find things are much easier now than seven years ago. The current process for regulatory qualification of digital endpoints is more established and the regulators have a much better understanding of the issues involved on this front.
These views were expressed by Laurent Servais, professor of pediatric neuromuscular diseases at the University of Oxford in the UK, who along with many others helped develop the first digital endpoint – real-world walking speed as measured by an ankle-worn device – to be qualified by