August 09, 2022
Before a prescription drug or device can become available to the general public, it has to go through clinical trials to determine its safety and effectiveness. The problem is that most people don’t even know these trials exist, let alone how to participate in them.
Chi-Ren Shyu, Shumaker Professor in electrical engineering and computer science, believes blockchain is the key to connecting patients to the companies developing potentially life-saving treatments. Shyu is also director of the MU Institute for Data Science and Informatics.
Blockchain is a decentralized ledger that allows multiple stakeholders to access and share information. Stakeholders such as drug companies and healthcare providers would agree upon shared guidelines — in this case ensuring that policies comply with federal guidelines around drug development. Users would then be able to contribute to the database, however they would not be able to edit or alter previous entries, ensuring that records are protected.
The system would then rely on smart contracts, or programs that run when predetermined conditions are met, to match patients to specific trials.
Using this type of system would benefit all parties. For drug companies — about half of which don’t recruit as many patients for clinical trials as they want — it would provide a new way to find prospective subjects. Healthcare providers could see options available outside of their immediate communities.
And patients would have direct access to treatment options without having to rely on doctors for that information. Patients could find trials based on medical conditions, meaning they would not have to share identifying information upfront.
“As a patient, I want to see what options are available to me,” Shyu said. “If a first line of treatment failed, and a second failed, I want to see what else is out there and to participate in clinical trials. This platform provides that kind of environment, empowering patients to see what’s available.”
Shyu has been developing the idea of incorporating blockchain in clinical trials since 2018 when he took second place at an IEEE challenge hosted by the IEEE Standards Association for the idea. Over the past four years, he’s published several papers expanding on the idea, working with global collaborators.
In his most recent study, Shyu showed that the blockchain system matched 1,145 patients in 1.39 seconds using 10 recruitment criteria with an automated matching mechanism implemented by the smart contract.
To ensure the blockchain technology is compliant with human clinical trials applications, which are highly regulated, he’s now working with industry partners to seek additional funding to apply blockchain to clinical trials for animal health.
“Then we could move into human nutrition, and then human drugs or devices,” Shyu said. “It’s a journey, but the technology is mature enough to move forward.”
Be part of life-changing innovations. Become a Mizzou Engineer.