Digital Biomarkers for Trial Endpoints Hold Key to New Treatments

The use of digital health technologies across healthcare and drug development has accelerated. A new paper in the Journal of Parkinson’s Disease titled “Digital Progression Biomarkers as Novel Endpoints in Clinical Trials: A Multistakeholder Perspective,” coauthored by experts across diverse disciplines, highlights how new remote monitoring technologies present a tremendous opportunity to advance digital medicine in healthcare even further, specifically in Parkinson’s disease.

Global collaborative efforts are under way with the goal of advancing the use of digital health technologies for use in Parkinson’s clinical research and therapeutic trials—yet several gaps and barriers stand in the way of success. These include data security issues, the rapidly evolving nature of the technology, lack of consensus on data standards, vast diversity of distinct studies carried out on different devices, and the need for open science.

The Critical Path for Parkinson’s (CPP’s) Digital Drug Development Tool team at Critical Path Institute consists of industry members, scientific academic advisors, representatives of patient research organizations, and people living with Parkinson’s—all collaborating across the globe to seek advice early and often from regulatory agencies. Companies advancing innovative therapies for the treatment of Parkinson’s see the promise of digital technologies, yet they also recognize that there are gaps that are too challenging to overcome on their own.

CPP’s focus on the voice of people living with Parkinson’s aligns with the visions of the U.S. Food and Drug Administration and European Medicines Agency for patient-focused drug development. Sharing costs, risks, and knowledge will streamline a more efficient runway for regulatory endorsement in the future.

“We felt it was imperative to come together on this paper, at this moment, to bring attention to how existing digital health technologies can complement traditional modalities and transform and accelerate clinical research and therapeutic development,” said project leader Professor Lynn Rochester at the University of Newcastle.

Dr. Soania Mathur, who has lived with Parkinson’s for 22 years, inspired the team of five women leaders to work on this paper across different countries during the pandemic. “It is vital to include the patient voice to drive the sense of urgency when it comes to Parkinson’s research,” she said. “As patients, we fully experience the unrelenting progression of this disease [and] the ongoing daily challenges that we live with. From the direction of research to identifying the tools that can estimate relevant outcome measures in the search for new therapeutics that are directed toward disease modification or improved quality of life, patient input is absolutely integral to its success. This collaboration kept that sense of urgency at the forefront.”

Edited by Gary Cramer