- Researchers at University of California San Francisco (UCSF) have developed a proof-of-concept method for using blockchain to safeguard data integrity of clinical trials.
Blockchain creates an audit trail that makes it easy to detect tampering with results, such as making the treatment look more effective than it is or diminishing the impace of side effects.
“We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy,” the researchers wrote in their article describing their proof of concept.
The researchers related that they used data from a completed clinical trial, simulated the trial using a proof-of-concept web portal service, and tested resilience to tampering with the data.
“Everyone is talking about how blockchain is going to revolutionize many of the data challenges in medicine, and here is one use that finally might make sense,” said Atul Butte, who is the Priscilla Chan and Mark Zuckerberg Distinguished Professor and director of the Bakar Computational Health Sciences Institute at UCSF. “We think it could someday be useful for pharma companies running clinical trials.”
Butte, along with Daniel Wong and Sanchita Bhattacharya, authored the paper describing the blockchain proof of concept.
“A system built upon our prototype could be developed to enable oversight of international clinical trials, for example,” Butte said. “And it could be expanded to provide more access to raw data for research scientists, the way we do with ImmPort, or deliver trial results to the public.”
Wong developed the blockchain system to work through a web portal. Each time data was entered on a particular trial participant, the sender, receiver, timestamp, file attachment containing the data, and the hash of the previous block of data pertaining to the participant were recorded on to a new block with a distinct signature.
“It makes it really obvious when someone’s changing something,” Wong said. “You can see who put their hands on it, who made it, who changed it, and who received it.”
The researchers assessed whether blockchain could provide a traceable audit trial of clinical trial data for regulators, a useful service for the clinical trials network, and a better way to report adverse events.
The clinical trial proof of concept depends on having a regulator with centralized authority to operate the web portal, register all parties, and keep a ledger of the blockchain’s hashes.
The researchers concluded that the blockchain-based service “could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials.”
Ensuring data integrity is one of the good use cases for blockchain in healthcare identified by Beth Israel Deaconess Medical Center CIO John Halamka at a recent MIT Sloan conference. Other good use cases include physician credentialing and data sharing consent.
The Synaptic Alliance includes Aetna, Ascension, Humana, MultiPlan, Optum, Quest Diagnostics, and UnitedHealthcare. The first project of the Synaptic Health Alliance aims to put provider demographic information on a permissioned blockchain for members to access and maintain.
Federal and state laws require that health plans maintain directories containing information about physicians and other healthcare providers. Industry estimates suggest that $2.1 billion is spent annually across the healthcare system acquiring and maintaining provider data.
The Synaptic pilot project is exploring how blockchain technology can be used to actively share data with the aim of demonstrating potential administrative cost savings for health plans and healthcare providers, while improving care provider demographic data quality and consumers’ healthcare experience.