The Digital Medicine Society (DiMe) has announced a collaboration with a group of notable pharmaceutical companies, with the mission of advancing nocturnal scratch as a digital endpoint for atopic dermatitis. According to the group, driving broader acceptance of nocturnal scratch (itching at night, which can cause sleep disturbance and other issues) as a digital endpoint for atopic dermatitis.
The goal of pursuing the digital endpoint is to advance the effectiveness, efficiency, and value of research, leading to the development of novel medical products.
“This initiative aspires to be a blueprint for the development and deployment of digital endpoints in medical product development,” said 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,” Goldsack added.
DiMe reports that the organization is confident that digital endpoints present an opportunity to provide a more meaningful, complete understanding of patient conditions and responses. Incorporating digital endpoints into development reportedly stands to benefit patients through:
- reducing the time and cost associated with bringing new treatments to market
- alleviating the burden on trial participants and caregivers
- improving comprehension of how new therapies might affect daily life.
COVID-19 has helped the advancement of digital endpoints in clinical research. DiMe reports that its library of digital endpoints indicates 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, DiMe reports that 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. Additionally, almost every endpoint in the library is unique, potentially stifling progress towards a shared understanding of how these new digital endpoints reflect health status.
Collaboration among stakeholders (occasionally among potential competitors) presents a potential route to improvement. The collaboration among DiMe and the pharmaceutical firms reportedly is aimed at bringing a well-developed digital measure to fruition as a broadly accepted digital endpoint for use in medical product development.
DiMe is a professional society serving the digital medicine community, with the goal of driving scientific progress and broad acceptance of digital medicine to enhance public health. The organization seeks to bring together experts from any and all disciplines involved in digital medicine, including regulators, ethicists, clinicians, citizen scientists, and others.