The Digital Medicine Society (DiMe) has released a new set of resources to advance the use of digitally measured nocturnal scratch as a meaningful endpoint for atopic dermatitis (AD). These new tools, along with DiMe’s previous work to support digital clinical measures, lay the groundwork for future use of the measure in clinical research, technology development, and reimbursement decisions – thereby furthering dermatology research and improving the lives of AD patients and caregivers.
A live launch event is being held today, Thursday, September 8 at 10 am ET, with Matthew Diamond (chief medical officer for digital health at the US Food and Drug Administration [FDA] Center for Devices and Radiological Health [CDRH]) and Thorsten Vetter (senior scientific officer at European Medicines Agency [EMA]). The speakers are set to highlight the effort, DiMe’s first pre-competitive digital measures development project, and outline each new resource including study findings, simple implementation resources, a measure ontology, and a value framework to support reimbursement decisions.
According to the organization, in addition to advancing AD research and care, this work also stands to serve as a blueprint for the broader development and deployment of digital endpoints in medical product development. The number of unique digital endpoints being used in industry-sponsored trials of new medical products increased by over 950% between October 2019 and May 2022.
The number of sponsors using these products in medical product development increased from 12 to 96 in the same time span. However, the industry has yet to see a new medical product approved on the basis of a digital endpoint. The alignment on nocturnal scratch is a critical step toward industry alignment and acceptance.
“Until now, there’s been a lack of direction and alignment for making decisions on and using digital measures, which has prevented the advancement of medical product development and healthcare,” said Jennifer Goldsack, CEO of DiMe. “This work addresses that barrier by providing pharmaceutical companies with the tools needed to de-risk the selection of this endpoint and arming technology innovators with what they need to build a valuable digital measurement product.”
“We applaud our partners for coming together with a common goal and - on a rapid, tech timeline - setting a new industry standard that will further medical product development, advance healthcare, and improve people’s lives,” Goldsack added.
Founding project partners Abbvie, Janssen, Novartis, Pfizer, and UCB, along with project collaborators Advancing Innovation in Dermatology, Almirall, Eli Lilly, GSK, Leo Pharma, and Sanofi, were the leading organizations that collaborated with DiMe on 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.
“Nighttime scratching is painful, robs children and parents of sleep, and causes a huge amount of anxiety for patients. When AD is flaring, scratching at night is not something a person can control and we hear from our community about the horror of waking up in bloody sheets. Navigating daily life on minimal sleep and managing stress take a toll because there’s no easy solution unless the eczema can be treated and brought under control,” said Korey Capozza, founder and executive director of Global Parents for Eczema Research. “DiMe’s work in convening stakeholders to find new ways of measuring nighttime 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 the condition."
This is the first of many digital measures deployment projects set to be launched by DiMe. It is also leading work on developing digital measures for Alzheimer’s and Related Dementias, with additional projects on the horizon. Historically, DiMe has led the development and advancement of the adoption of digital clinical measures through other work and resources, including:
- Verification, Analytical Validation, and Clinical Validation (V3)
- The Playbook: Digital Clinical Measures Edition
- Evaluating Connected Sensor Technologies (EVIDENCE) Checklist
- Patients, Pharma, Payers (the 3Ps of Digital Endpoint Value)
- Sensor Data Integration (SDI)
DiMe is committed to creating and disseminating new digital health approaches and tools, as well as also to sharing user experiences with the broader 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 further the safe, effective, equitable, and ethical use of digital medicine to redefine healthcare and improve lives.