Syndication Model Poised to Accelerate Digital Healthcare Advancements

A syndication model explored in a Parkinson’s disease study may accelerate digital healthcare by advancing 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 multi-member expertise and risk sharing,” said John Wagner, MD, PhD, co-author of the paper and chief medical officer at Koneksa, in a company press release. “By fostering a curated collaboration across key stakeholder groups, this model enables real-time data insights, faster study launches, and more efficient validation of digital measures, significantly accelerating the development of novel therapies for patients.”

The paper, titled “Syndication in science: Curated collaboration,” was published in Curated Collaboration and co-authored by researchers from Koneksa, Takeda, Regeneron, and Merck.

Testing new treatments often requires reliable measures to assess effectiveness, which in Parkinson’s disease typically involve expert-led clinical assessments. However, these assessments can be subjective and limited to isolated observations, missing day-to-day nuances of the disease.

Advances in digital technologies, like smartphones and wearable devices, offer opportunities to routinely collect objective, real-world data during clinical studies. These technologies could provide a more comprehensive way to measure disease activity, but they must first be validated as reliable tools for clinical research.

Traditional studies of emerging healthcare technologies are typically designed in two ways: a single company runs its own study, which simplifies the process but increases financial risk, or multiple companies collaborate, which spreads the risk but slows the process. The syndication model offers a middle ground. A single company launches a study but partners with other stakeholders—such as drug developers—to provide funding, scientific input, and result analysis.

This approach balances speed and collaboration, allowing studies to move quickly while distributing risk and leveraging shared expertise. “Not only does data streaming ensure data quality is continuously addressed, but it also creates opportunities for the community to collaborate, brainstorm, and interpret data from the very first patient to the last,” the researchers noted.

The syndication model is currently being explored in the Parkinson’s-focused LEARNS study (NCT06219629), sponsored by Koneksa. The study evaluates digital biomarkers using mobile electroencephalogram (EEG), wearable devices, and smartphone-based assessments. Data is captured remotely through the Koneksa Neuroscience Toolkit, which features iPhone-based patient assessments and wrist-worn device data collection.

Other companies have joined the effort, including Merck (MSD outside the U.S. and Canada) in March and Regeneron in September.

“The LEARNS study demonstrates the syndication model’s potential to transform clinical research,” said Dave Hurry, chief data officer at Koneksa. “By validating digital health technologies through multi-stakeholder collaboration, we’re advancing reliable, patient-friendly tools for tracking disease progression and treatment response. Digital biomarkers are reshaping drug development, and Koneksa is leading the way in providing the evidence and community for this technology.”

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