The Digital Medicine Society (DiMe) has released a new set of resources to advance the use of digitally measured nighttime scratches as a meaningful endpoint for atopic dermatitis (AD). These new tools, along with DiMe’s previous work to support digital clinical measurements, lay the foundation for future use of measurement in clinical research, technology development, and reimbursement decisions – advancing dermatology research. and improving the lives of AD patients and caregivers.
A live launch event is taking place today, Thursday, September 8 at 10 a.m. ET, with Matthew Diamond (Chief Medical Officer for Digital Health at the U.S. Food and Drug Administration [FDA] Center for Devices and Radiation Health [CDRH]) and Thorsten Vetter (Scientific Officer at the European Medicines Agency [EMA]). Speakers should highlight the effort, DiMe’s first precompetitive numerical measurement development project, and describe each new resource, including study results, simple implementation resources, measurement ontology, and framework. of value to support reimbursement decisions.
According to the organization, in addition to advancing research and care for Alzheimer’s disease, this work should also serve as a model for the wider development and deployment of digital terminals in the development of medical products. The number of unique digital terminals used in industry-sponsored trials of new medical products increased by more than 950% between October 2019 and May 2022.
The number of sponsors using these products in the development of medical products increased from 12 to 96 in the same period. However, the industry has yet to see a new medical product approved based on a digital endpoint. Alignment on Night Stripes is a critical step towards alignment and industry acceptance.
“Until now, there has been a lack of direction and alignment for making decisions about and using digital metrics, which has impeded the advancement of medical product development and healthcare.said Jennifer Goldsack, CEO of DiMe. “This work addresses this barrier by providing pharmaceutical companies with the tools to reduce the risk of selecting this endpoint and by equipping technology innovators with what they need to create a valuable digital measurement product..”
“We applaud our partners for coming together with a common purpose and – in a rapid technological timeline – to establish a new industry standard that will drive the development of medical products, advance healthcare and improve people’s lives” , Goldsack added.
Founding project partners Abbvie, Janssen, Novartis, Pfizer and UCB, along with Advancing Innovation in Dermatology project collaborators Almirall, Eli Lilly, GSK, Leo Pharma and Sanofi, were the primary organizations that collaborated with DiMe in this effort. . In just nine months, they conducted a mixed-methods study, a comprehensive literature review, a series of workshops, a series of focus groups with payers, and convened a meeting with regulators — all of which informed the development of these open access resources. .
“Nocturnal scratching is painful, deprives children and parents of sleep, and causes enormous anxiety in patients. When Alzheimer’s disease strikes, scratching at night is not something a person can control, and our community tells us about the horror of waking up in bloody sheets. Navigating daily life with minimal sleep and dealing with stress has adverse consequences as there is no easy solution unless eczema can be treated and brought under controlsaid Korey Capozza, founder and executive director of Global Parents for Eczema Research. “DiMe’s work to bring stakeholders together to find new ways to measure nocturnal scratching using new digital tools will help improve measurement of this distressing facet of AD and improve the lives of children and adults. struggling with this disease.“
This is the first of many digital measurement deployment projects to be launched by DiMe. He is also leading work on the development of numerical measures for Alzheimer’s disease and related dementias, with other projects on the horizon. Historically, DiMe has led the development and advancement of digital clinical measurement adoption through other work and resources, including:
DiMe is committed to creating and disseminating new digital health approaches and tools, as well as sharing user experiences with the wider community. The organization encourages all users of any DiMe resource to contribute to its “Resources in Action” case study hub by sharing how you are using resources to support the safe, effective, equitable and ethical use of digital medicine for redefining health care and improving lives. .
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