New Collaboration Seeks to Establish Nocturnal Scratch as a Digital Endpoint for AD

Advancing the use of digital endpoints in medical research and care, a new collaboration between the Digital Medicine Society (DiMe) and AbbVie, Janssen Research & Development LLC, Novartis Pharma AG, Pfizer Inc., and UCB is focused on establishing nocturnal scratch as a digital endpoint for atopic dermatitis.  By helping to drive the broad acceptance of nocturnal scratch as an evidence-based, meaningful endpoint for atopic dermatitis, the initiative aims to advance the effectiveness, efficiency, and value of research leading to the development of new medical products.

The number of unique digital endpoints being used in industry-sponsored trials of new medical products has increased from 34 to 226 over the past two years. The number of research study sponsors actively collecting digital endpoints in clinical trials has increased from 12 to 69. Despite a 665% uptick in the use of these measures, the industry has yet to see a new medical product approved on the basis of a digital endpoint.

DiMe says it believes that digital endpoints present an opportunity to provide a more meaningful and complete understanding of patients’ conditions and responses. By incorporating digital endpoints into medical product development, patients could benefit from the potential reduced time and cost of bringing new therapies to market, the lessened burden of trial participation on patients and caregivers, and improved understanding of how new therapies affect daily living.

“This initiative aspires to be a blueprint for the development and deployment of digital endpoints in medical product development,” says Jennifer Goldsack, CEO of DiMe. “We applaud our collaboration partners for coming together with a common goal, to establish digitally measured nocturnal scratch as a broadly accepted endpoint for use in registrational trials. Together, we will work to set the industry standard and position those involved to lead the field in global best practice as they translate this work in a single context of use to other therapeutic areas and other measures.”

For more on the initiative, check out the December edition of Practical Dermatology® magazine, coming soon.