Background

Neurological disorders, which usually affect the brain, spinal cord, or peripheral nervous system, are the leading cause of disability worldwide¹. New treatments and novel disease management strategies are needed to counter rising healthcare costs and an aging population in many countries. However, the R&D efforts required to develop urgently needed innovations is expensive and hard to scale. It is often challenging to recruit sufficient numbers of patients for trials, and frequent visits to sometimes-distant trial sites can represent an additional burden to patient participation². Fortunately, many individuals remain willing to participate in clinical trials, and the research system owes it to them to gather data that is patient-centric and to do so efficiently and, if possible, remotely.

The FDA defines Digital Health Technologies (DHTs) as systems that use computing platforms, connectivity, software, and/or sensors, to collect patient data for healthcare purposes. Illustrative examples include various connected sensors, such as smartwatches or smartphone applications, that are used for passive data collection and can monitor disease activity. By gathering more continuous and detailed information, DHTs can enable more efficient and decentralized clinical research and can facilatate the collection of more patient-centric outcomes. With more data about our patients’ digital phenotypes, novel and more precise treatment strategies might also be possible.

Author’s Quote:

As many aspects of our daily lives become increasingly intertwined with the digital world, many of us have grown accustomed to the speed and ease of scaling digital solutions. Since smart technologies are also increasingly used in clinical research, we wondered: how smart are studies in neurology these days? And how has the used of digital technologies evolved over time?

The paper

Given compelling opportunities for DHTs in clinical research more broadly, we asked how DHTs have been used in neurology trials in recent years. The paper “Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials” analyzes the development of DHT usage in neurology trials based on trials registered on ClinicalTrials.gov. We chose four major, chronic neurological diseases that represent different subfields of neurology and are key drivers of lost disability-adjusted life years³. Based on the methodology introduced in this journal by Marra et al.⁴, we pulled trials for Alzheimer’s disease (AD), Parkinson’s disease (PD), multiple sclerosis (MS), and epilepsy and analyzed developments in these trials both quantitatively and qualitatively. The author team was composed of an interdisciplinary team of medical doctors, computer scientists, and a health economist, and included a patient and with one of the focal disorders.

We identified 441 trial-indication pairs over the years 2010-2021 (inclusive), representing 430 individual trials. Trials employing DHTs were most frequently found in PD, followed by MS, AD, and epilepsy. The use of DHTs in trials increased rapidly over our period of study, growing from less than 1% in 2010 to more than 11% in 2020, with different dynamics across the analyzed diseases. Whereas motor tracking capabilities were adopted earlier in PD, the increasing readiness of other tracking modalities were seen in other diseases, such as AD, in more recent years.

In investigating how DHTs were use, we feature-mapped the trials for different scenarios and technologies observed in the data. While DHTs were used for symptom tracking of patients in most trials, other scenarios, such as treatment adherence in epilepsy or caregiver monitoring in AD, were also seen. The article also highlights the increasing use of novel tracking technologies, such as speech analysis or digital cognition assessment. In the article’s tables (see also the Supplementary Material), the resulting feature data are stratified by disease and time in more detail. Did you know that MS trials using DHTs involve exercise especially frequently? Or that sleep tracking is (relatively) more frequently used in AD and epilepsy trials? Some key findings are summarized in the figure below.

In our sample, we observed both trials already using digital endpoints for analyzing other interventions and those validating DHTs for future use. The underlying technology platforms for DHTs were usually wearables or smartphones, highlighting the great potential of these everyday technologies to support medicine’s digital transformation. We also mapped trials to their primary locations, allowing interested readers to explore exciting examples in more detail via web application linked in the publication. We observed that there appear to be different typs of geographic clusters: some related to medical indications while others—especially in the US—appear to be based on the technology used.

Key Take-Aways

DHTs are increasingly used in neurology trials, with novel tracking technologies logging increased use in recent years.

Since 2010, neurology trials have become smarter across major indications as they apply connected sensors in contexts where symptoms lend themselves to digital technology. As trials evolve to incorporate a greater variety of data sources and modalities, novel trial designs and a better collection of data in real-world settings are likely to play a growing role in patient-centered R&D.

Interested? Read the article for yourself: https://www.nature.com/articles/s41746-023-00767-1