Digital Medicine Society Convenes Pharmaceutical Leaders to Collaborate on New Digital Endpoint

The collaboration between pharma companies to advance a digital endpoint for use in medical product development marks a profound change for the industry

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Digital Medicine Society (DiMe)

Nov 02, 2021, 07:00 ET

BOSTON, Nov. 2, 2021 /PRNewswire/ -- The Digital Medicine Society (DiMe) announced today a new collaboration with AbbVie, Janssen Research & Development LLC, Novartis Pharma AG, Pfizer Inc., and UCB to advance 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, this initiative aims to advance the effectiveness, efficiency, and value of research leading to the development of new medical products.

DiMe 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.

COVID-19 has helped fuel the advancement of digital endpoints in clinical research. Data from DiMe's library of digital endpoints shows that, over the last two years, the number of unique digital endpoints being used in industry-sponsored trials of new medical products has increased from 34 to 226, and the number of research study sponsors actively collecting digital endpoints in clinical trials has increased from 12 to 69. However, 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. Moreover, almost every endpoint in the library is unique, inhibiting progress towards a shared understanding of how these new digital endpoints reflect health status.

Industry collaborations could be a solution to this uncoordinated approach. This initiative is laser-focused on bringing a well-developed digital measure to bear as a broadly accepted digital endpoint for use in medical product development.

"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."

About the Digital Medicine Society: The Digital Medicine Society (DiMe) is the professional society serving the digital medicine community, driving scientific progress and broad acceptance of digital medicine to enhance public health. At DiMe, our commitment to fully integrating experts from all of the disciplines comprising digital medicine is unwavering. From regulators to white-hat hackers, ethicists to engineers, and clinicians to citizen scientists, we are proud to welcome all experts committed to ensuring that digital medicine realizes its full potential to improve human health. Join us!

Media Contact: Jamie Gray, [email protected], 310.699.3163

SOURCE Digital Medicine Society (DiMe)