Richard Brooks of Clemson University is using the same technology that underpins bitcoin to create a new way of securing data in clinical trials, a project that could make pharmaceuticals safer and cheaper to bring to market.
The technology, blockchain, creates a public ledger of data entries that cannot be modified after the fact and ensures data integrity. Blockchain shot to prominence as bitcoin’s value skyrocketed in December, but the tech community is finding a range of uses beyond cryptocurrencies.
Richard Brooks, left, works with postdoctoral researcher Lu Yu in his Riggs Hall office.
Brooks, a professor of electrical and computer engineering, joined with researchers from three other universities to create the clinical-trials blockchain. The idea is to make clinical trials less expensive and higher quality, which could translate to higher quality pharmaceuticals and lower costs to produce them, he said.
Further, the Food and Drug Administration would have clearer audit trails to check for problems, and medical universities could have a clearer approach to meeting FDA requirements, Brooks said.
“We very much want to commercialize this,” he said.
The team has some wind in its sails after beating six other competitors to win first place in the White Board Challenge at the Blockchain for Clinical Trials Forum.
The Orlando forum was sponsored by a leading professional organization, the IEEE Standards Association, and was attended by representatives from several tech start-ups and some of the biggest names in pharmaceuticals, including Pfizer and Bayer Pharmaceuticals.
In the wake of its victory, the Brooks team is running alpha-level tests to find and correct problems on a prototype of “a blockchain system that provides an immutable audit trail for clinical-trial electronic records,” he said.
“We are also looking at the features we should have in the second version of it,” he said. “At the same time, we are discussing a proof of concept prototype in an operational environment with at least two medical institutions.”
Clinical trials help determine the risks and benefits of new treatments, but they are becoming more expensive. Developing a new prescription medicine that gains market approval takes more than a decade and costs about $2.6 billion, according to the Tufts Center for the Study of Drug Development.
The blockchain that won the challenge started with an idea that Brooks and his team began development two years ago with funding from the National Science Foundation. The original idea was to use blockchain to ensure academic integrity by making it harder to forge data.
The team was invited to enter the White Board Challenge after doing a webinar on the academic-integrity blockchain, Brooks said.
“We were able to come up with a paper for the challenge within a short period of time in large part because this fit very well with the work we had been doing,” he said. “We have a system set up for guaranteeing academic integrity, and the clinical trials problem to a large extent was a problem of academic integrity.”
Blockchain is an unchanging digital ledger that provides a way of securely recording and making transactions. The database is shared across a network of computers, rather than in one place, which enhances the security.
The blockchain that the Brooks group is creating could also make negative results available to researchers, he said. Those results now largely remain unavailable because academic journals typically publish results only from studies with positive results.
“You would register data and wouldn’t necessarily have to go through the publication process,” Brooks said. “That would be one way of having negative results be available and not being filtered.”
The name of the winning paper was “Scrybe: A Blockchain Ledger for Clinical Trials” and can be found here: https://blockchain.ieee.org/clinicaltrialsforum-2018/wp-content/uploads/sites/7/2018/02/Clemson_WhitePaper.pdf
Collaborators were: Kuang-Ching “K.C.” Wang, Lu Yu and Jon Oakley, of Clemson University; Anthony Skjellum of the University of Tennessee at Chattanooga; Jihad Obeid and Leslie Lenert of the Medical University of South Carolina; and Carl Worley of Auburn University.
Daniel Noneaker, chair of the Holcombe Department of Electrical and Computer Engineering, congratulated Dr. Brooks and his team.
“The win is a testament to their leadership in a fast-growing technology that has a lot of potential,” he said. “This is a well-deserved honor and helps shine a light on the department among our peers.”
