The use of digital health technologies in healthcare and drug development has accelerated. A new paper in Journal of Parkinson’s Disease entitled “Digital Progression Biomarkers as Novel Endpoints in Clinical Trials: A Multistakeholder Perspective”, which was co-authored by experts from various disciplines, shows how new remote monitoring technologies offer a tremendous opportunity to advance digital medicine in healthcare even further, especially in the Parkinson’s disease.
There are worldwide collaborations with the aim of promoting the use of digital health technologies for use in clinical Parkinson’s research and in therapeutic studies – but several gaps and obstacles stand in the way of success. These include issues of data security, the rapidly evolving nature of technology, lack of consensus on data standards, a wide variety of different studies conducted on different devices, and the need for open science.
The Critical Path for Parkinson’s (CPPs) Digital Drug Development Tool team at the Critical Path Institute consists of members of the industry, scientific academic advisors, representatives from patient research organizations, and people living with Parkinson’s – all of whom work together worldwide to seek early and frequent advice Supervisory authorities. Companies advancing innovative therapies to treat Parkinson’s see the promise of digital technology, but also recognize that there are gaps that are too difficult to overcome on their own.
CPP’s focus on the voice of people living with Parkinson’s is in line with the vision of the US Food and Drug Administration and the European Medicines Agency for patient-centered drug development. Sharing costs, risks and knowledge will create a more efficient runway for government approval in the future.
“We felt it was imperative at this moment to work together on this paper to raise awareness of how existing digital health technologies can complement traditional modalities and transform and accelerate clinical research and therapeutic development,” said Project Leader Professor Lynn Rochester of the University of Newcastle.
Dr. Soania Mathur, who has lived with Parkinson’s for 22 years, inspired the team of five female executives to work on this paper in different countries during the pandemic. “It is important to include the patient’s voice in building a sense of urgency in Parkinson’s research,” she said. “As patients, we fully experience the inexorable progression of this disease” [and] the constant daily challenges 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 target disease modification or improved quality of life, patient contribution is absolutely critical to success. This collaboration kept this sense of urgency in the foreground. “
Edited by Gary Cramer