A consortium of five major pharmaceutical companies has partnered with the Digital Medicine Society (DiMe) to develop nocturnal scratch as a standardized digital endpoint for atopic dermatitis clinical trials. The collaboration involves AbbVie, Janssen, Novartis, Pfizer, and UCB, all companies with significant investments in the competitive atopic dermatitis market.
Addressing Digital Endpoint Fragmentation
The initiative comes as the digital medicine sector faces significant fragmentation challenges. Despite DiMe's crowdsourced library of 226 digital endpoints being used by 69 trial sponsors, no new medical product has yet been approved based solely on a digital endpoint. This gap persists even though digital measures saw substantial adoption during the pandemic, particularly for decentralized trials.
"In part that is because many endpoints have been developed by individual groups and vendors – sometimes competing with each other – leading to fragmentation of the emerging sector," according to DiMe. The organization believes that bringing pharmaceutical companies together as a group represents a pathway to inject standardization into digital endpoint identification and validation.
Nocturnal Scratch as a Clinical Measure
The nocturnal scratch endpoint will utilize wearable sensors, such as accelerometers in smartwatches, to measure night-time scratching behavior in patients with the inflammatory skin condition. This approach aims to provide a more complete and meaningful picture of atopic dermatitis impact on patients while reducing the burden of trial participation.
If validated and accepted as a meaningful, evidence-based endpoint, nocturnal scratch could significantly aid in the development of new medical products for atopic dermatitis. The digital measurement approach may also benefit patients through reduced time and cost of bringing new therapies to market.
Industry Standardization Goals
Jennifer Goldsack, DiMe's chief executive, emphasized the broader implications of the collaboration: "This initiative aspires to be a blueprint for the development and deployment of digital endpoints in medical product development. 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."
To support the broader digital health ecosystem, DiMe has developed a digital health vendor assessment toolkit designed to help trial sponsors more effectively evaluate potential collaboration partners in the fragmented vendor landscape.
Competitive Atopic Dermatitis Landscape
The focus on atopic dermatitis reflects the condition's emergence as a significant battleground in pharmaceutical development. All participating companies have substantial interests in this therapeutic area, which has become characterized by fierce competition for market share and dozens of new candidates progressing through mid- to late-stage development pipelines.
The collaborative approach to digital endpoint development may provide these companies with a competitive advantage while simultaneously advancing the broader adoption of digital measures in clinical research across the pharmaceutical industry.
