Insights From HumanFirst Show Breadth of Pharmaceutical Investment in AI/ML and Digital Endpoints in Clinical Trials

For the first time, HumanFirst Institute’s analysis puts numbers to the digital biomarker and clinical outcome assessment (COA) revolution happening in life sciences

SAN FRANCISCO, Sept. 28, 2023 /PRNewswire/ — 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. The analysis also shows that:

  • 60% of the 1300+ pharma-sponsored digital endpoints are secondary endpoints
  • Nearly two-thirds of trials deploying digital endpoints are phase 2 or phase 4 trials
  • 10 therapeutic areas represent 82% of all pharma trials deploying digital endpoints

“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.”

Review the full analysis at HumanFirst.

About HumanFirst 
HumanFirst is a cloud-based technology company for life sciences. The Atlas platform by HumanFirst provides comprehensive insights on AI-powered biomarkers and COAs, spanning multi-modal technologies, including connected sensor-derived DHTs, questionnaires, blood and fluid markers, and imaging to accelerate drug development.

HumanFirst’s solutions reduce costs and de-risk trial portfolios by:

  • Accelerating the time to deploy in a trial by aggregating and curating evidence to enable faster decisions on protocol design
  • Increasing likelihood of submission approval with better data and comprehensive evidence and insights
  • Prioritizing patient-centered research by helping measure what matters to patients

To date, HumanFirst curates more than 15,000 digital measures and biomarkers captured from more than 3,100 digital health technologies deployed across 1,700 clinical trials. Each measure is associated with robust evidence from 9,000+ peer reviewed publications, research papers and conference abstracts.  Customer results with HumanFirst include up to 12 months’ acceleration to trial deployment leading to millions in cost savings.

HumanFirst’s solutions have been used by leading academic medical institutions such as Harvard and Stanford, and by 24 out of 25 of the world’s largest pharmaceutical companies to unlock evidence-based precision measures that bring better treatments to market, faster.

Visit to learn how you can Be First with HumanFirst.

Media Contact:
Nita Nehru

SOURCE HumanFirst