ActiGraph has introduced the Digital Endpoint Collaboration for Outcome DEvelopment (DECODE) in Nocturnal Scratch, a transformative cross-industry initiative in collaboration with pharmaceutical giants such as Janssen Research & Development and Takeda, with valuable support from UCB. This strategic working group aims to pioneer a novel, fit-for-purpose measure to assess scratch behaviour—a pivotal factor influencing the quality of life in dermatological conditions.
The impetus for the DECODE initiative stems from the compelling need identified by patients and caregivers for a validated and scalable solution to evaluate scratch behaviour. The collaborative efforts of the DECODE working group hold the promise of introducing a groundbreaking dimension to the evaluation of scratch behaviour during clinical research. The development of a nocturnal scratch endpoint is anticipated to offer new insights into the efficacy of investigational drugs, facilitated by real-time and continuous measurements through a low-burden digital solution.
This industry collaboration aligns seamlessly with the FDA's draft guidance titled "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations," emphasising the importance of a fit-for-purpose solution backed by rigorous verification and analytical validation. The DECODE working group, featuring the participation of multiple pharmaceutical members, is committed to addressing these challenges collaboratively, propelling advancements in this crucial area of research.
Jeremy Wyatt, CEO of ActiGraph, emphasised the significance of a collaborative approach, stating, "In order to make digital health technologies a mainstream component of clinical research, we realise that a collaborative approach is the best way forward. 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 ensures that we are creating meaningful solutions that meet the needs of patients."
ActiGraph extends an invitation to potential collaborators to join the DECODE Nocturnal Scratch working group, underscoring the importance of collective efforts in crafting meaningful, patient-centric solutions within the realm of digital health technologies and clinical research. Further details and engagement opportunities are available on the DECODE Nocturnal Scratch webpage.
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