Syndication model seen accelerating progress in digital healthcare

16 Dec 2024, 13:00 by Marisa Wexler, MS · Parkinson's News Today

A syndication model being explored in a Parkinson’s disease study may help accelerate digital healthcare by speeding the development of digital tools to track disease activity, according to a published paper.

“The syndication model combines the speed of single sponsor studies with the advantage of having multi-member expertise and risk sharing,” said John Wagner, MD, PhD, co-author of the paper and chief medical officer at Koneksa, said in a company press release. “By fostering a curated collaboration across key stakeholder groups, this syndication model enables real-time data insights, potentially faster study launches, and more efficient validation of digital measures, significantly accelerating the development of novel therapies for patients.”

The paper, “Syndication in science: Curated collaboration,” was published in Curated Collaboration. Authors included researchers at Koneksa, Takeda, Regeneron, and Merck.

One of the most complicated aspects of testing a new treatment is finding valid measures that can be used to assess whether the treatment is working. In Parkinson’s disease, this usually involves workups done by experts in a clinical setting, but this paradigm has notable drawbacks: It can be somewhat subjective, and experts only get to observe patients for a snapshot in time, potentially missing nuances of how the disease affects day-to-day life.

The advancement of digital technologies like smartphones and smartwatches has opened new frontiers in biomedical research. Scientists are increasingly interested in findings ways to use these technologies to routinely collect data on people participating in clinical studies. In theory, this could allow for a more objective and holistic approach to measuring disease activity.

Spreading risk, sharing expertise

Implementing this kind of technology is easier said than done, in large part because it’s first necessary to conduct studies showing that the technology itself is a valid and reliable tool for measuring disease activity.

Traditionally, studies of emerging healthcare technologies have been conducted with one of two designs: Either a single company runs its own studies, or several companies team up to run a study collaboratively. Each of these approaches has pros and cons. When there’s one study sponsor, designing and implementing the study is fairly straightforward, but the company takes on a lot of logistic and financial risk in running the study. Doing a collaborative study spreads the risk, but having multiple parties involved in running the study can prolong the process.

The syndication model is a middle ground between these two approaches. One company with sufficient economical and scientific resources launches a clinical trial to test an emerging technology, but with the explicit intent of partnering with other companies (usually drug developers) to provide scientific and technical input, contribute to study funding, and analyze the results.

This approach can offer benefits for all involved, the researchers said. Syndicated studies can be run nearly as fast as single-sponsor studies but with risk sharing, and all members of the syndicate get to learn from the study results and build on each other’s expertise.

“Not only does data streaming ensure that data quality is addressed continuously, but it also affords new opportunities for the community to come together, brainstorm, analyze, and interpret the data from the very first patient in to the last patient out,” the researchers wrote.

The syndication model is being explored in a Parkinson’s-focused study called LEARNS (NCT06219629). Koneksa is sponsoring the study to assess the usability of digital biomarkers, such as those measured with mobile electroencephalogram (EEG, recordings of brain electrical activity), wearable devices, and smartphone-based assessments. Parameters are captured remotely with the Koneksa Neuroscience Toolkit, which features iPhone-based assessments from patients and data collected with a wrist-worn device. Other companies have been joining in: Merck (known as MSD outside the U.S. and Canada) joined in March, and Regeneron joined in September.

“The LEARNS observational Parkinson’s disease study highlights the potential of the syndication model to transform clinical research,” said Dave Hurry, chief data officer at Koneksa. “By validating digital health technologies through collaboration with multiple stakeholders, we’re advancing reliable, patient-friendly measures for disease progression and treatment response. Digital biomarkers are reshaping drug development, and Koneksa is providing the evidence and community for this technology.”