PENSACOLA, FL, November 20, 2023 - ActiGraph, a leader in wearable digital health technology and digital health sciences for clinical drug development and academic research, is proud to introduce the Digital Endpoint Collaboration to accelerate Outcome DEvelopment (DECODE) in Nocturnal Scratch. This cross-industry collaboration between pharmaceutical companies and ActiGraph will research a novel, fit-for-purpose measure to support the development of treatments for dermatological conditions. Initial DECODE working group members include Janssen Research & Development, LLC, a Johnson & Johnson company, and Takeda, with collaboration from UCB. ActiGraph continues to welcome additional partners to join the collaboration.
The DECODE working group’s primary mission is to address the need for a validated and scalable solution to assess scratch behavior, a critical factor affecting the quality of life in dermatological conditions. Patients and caregivers have expressed a strong desire for this type of assessment, and the measure has garnered substantial interest among drug developers. The successful development of a nocturnal scratch endpoint may introduce a new dimension in the evaluation of scratch behavior during clinical research. Continuous and real-life measurements of scratch behavior with a low-burden digital solution may provide insight into investigational drug efficacy.
Aligned with the FDA draft guidance entitled, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” a fit-for-purpose solution necessitates rigorous verification and analytical validation. The working group is forging a path forward by uniting multiple pharmaceutical members to accomplish this research collaboratively.
“In order to make digital health technologies a main-stream component of clinical research, we realize that a collaborative approach is the best way forward,” said Jeremy Wyatt, CEO of ActiGraph. “We’ve always taken this approach with our hardware and software solutions; today we’re taking the next step with our algorithm development. Bringing our partners to the table with us ensures that we are creating meaningful solutions that meet the needs of patients.”
ActiGraph is pioneering the digital transformation of clinical research. We provide end-to-end digital health technology (DHT) solutions by integrating and operationalizing the best hardware, software, and algorithms to generate reliable evidence and get the right treatments to the right patients, faster. ActiGraph’s medical-grade wearable technology platform has been used to capture real-world, continuous digital measures of activity, sleep, and mobility for nearly 250 industry-sponsored clinical trials and thousands of academic research studies. Appearing in over 22,000 published scientific papers to date, ActiGraph is the most experienced and trusted wearable technology partner in the industry.