Researchers at Montana State University (MSU) in the US have developed TrialWear, a wearable electronic device aimed at improving the safety of clinical trial participants.
The invention by assistant professor Elizabeth Johnson of MSU’s Mark and Robyn Jones College of Nursing is a patch that bears a scannable code connecting to essential patient information for use in non-research medical settings.
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The device is engineered to notify individuals through a text message to present the code to healthcare workers when they visit medical facilities.
This feature is intended to maintain trial integrity by preventing inadvertent treatment conflicts that could disqualify subjects from ongoing trials.
Johnson highlighted the challenges faced by patients in rural areas who are often overlooked for clinical trials due to coordination issues with larger, urban hospitals. TrialWear addresses this by electronically storing patient information, which historically was carried on easy-to-lose paper cards.
The device links to a database containing details about patient medications, guidelines and study restrictions.
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By GlobalDataFollowing a series of tests and patient feedback, the device’s final prototype was completed in July 2025.
MSU’s Technology Transfer Office is facilitating the commercialisation process, with plans to distribute the device to hospitals for use by trial subjects.
The packaging for TrialWear is being designed by Bozeman’s A&E Design.
Funding for the project has come from various sources including the National Institutes of Health, National Science Foundation, American Nurses Association, an MSU Venture grant and the US Economic Development Administration.
A grant proposal for $5m has also been submitted to the National Cancer Institute to expand collaborations with academic medical centres.
Johnson said: “Without clinical trial participants, we cannot get new drugs to bedside. When surveyed, most people here in the US are willing to go on a clinical trial.
“But only a small fraction may get to be on a clinical trial due to lack of access or safety issues. We are looking to narrow that gap.”
Johnson’s collaborative team at MSU includes those from the Geospatial Core Facility, graduate students in electrical engineering and data science, and a community engagement lead from the business school.
Specialists at the Massachusetts Institute of Technology have also contributed to refining the device’s components.
Originally conceived as a wrist-worn bracelet, TrialWear’s design evolved based on research and testing including eye-tracking studies with nurses at the Billings Clinic.
