The Digital Medicine Society, an interdisciplinary professional society for digital medicine, will lead an effort to establish nocturnal scratch as an evidence-based digital measure for eczema, according to a news release on Tuesday.
The aim is to create a verified and validated measure that drugmakers, medical device companies, researchers and others can use to develop new ways to diagnose and treat people with eczema, said DiMe CEO Jennifer Goldsack. Greater standardization among measures could make it less costly to develop new therapies and get them on the market faster.
"This initiative aspires to be a blueprint for the development and deployment of digital endpoints in medical product development," Goldsack said in a news release.
AbbVie, Janssen Research & Development, Novartis, Pfizer and UCB are supporting the venture, in part, because they have been working separately on similar projects, Goldsack said.
People with eczema often scratch themselves while they sleep, worsening their sleep and quality of life. Wearable sensors could help pharmaceutical companies, device makers and others evaluate a new eczema therapy's effectiveness, according to a recent study.
But there are no industry standards for digital endpoints, sensor-generated data collected from patients when they're at home, work, school or other non-clinical settings. DiMe hopes to change that by creating a measure with buy-in from patients, the healthcare industry, researchers and regulators.
"This measure offers enormous possibility to patients with atopic dermatitis," Goldsack said. "We can start measuring the facets of their condition that matter most to them in a way that is low burden."
The federal government hasn't approved a new medical product using sensor data in the past two years, even though there has been a 665% increase in unique sensor-generated health data in industry-sponsored clinical trials, according to DiMe. But that could start to change if drugmakers, medical device companies, researchers and regulators can agree on what to measure and how to measure it, Goldsack said.
