Regulators are increasingly approving AI-powered endpoints using digital health technologies (DHTs) in drug development. To quantify this trend, HumanFirst, life science’s first cloud-based platform for precision measures, today released an industry analysis showing just how many pharmaceutical sponsors have used digital endpoints to inform their drug development.
HumanFirst Institute is the collaborative research arm of HumanFirst, providing insights and industry analysis based upon robust data and evidence housed within the Atlas precision measures platform. Analysis through the HumanFirst Institute shows that more than 130 pharmaceutical and biotech sponsors have used over 1,300 AI-powered digital endpoints in their clinical trials.
“For the first time, we have real data and insights on how many pharmaceutical companies have been investing in digital endpoints,” said Andy Coravos, co-founder and CEO of HumanFirst. “Thanks to the breadth and depth of the Atlas platform, which includes 9,000+ pieces of evidence on 15,000 digital measures across 850 sponsors, we see there’s been an 11x increase in the use of digital endpoints in clinical trials in the past decade. This summer, the FDA released new guidance for AI/ML in drug development and the EMA approved stride velocity captured from a wearable as an acceptable primary endpoint. With the rise of DHT adoption in drug development, we’re living through a digital biomarker and clinical outcome assessment (COA) revolution in life sciences.”