UPDATED 13:57 EDT / FEBRUARY 22 2019

BLOCKCHAIN

Researchers build blockchain proof-of-concept to ensure clinical trial data integrity

Researchers at the University of California at San Francisco announced today the creation of a proof-of-concept blockchain distributed ledger designed to protect the integrity of data generated during clinical trials.

Using a blockchain, researchers believe, data can be protected by making it easier to identify when data is tampered with — such as when adverse reactions are removed or the treatment is made to look more effective than it was.

“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, director of the Bakar Computational Health Sciences Institute at UCSF. “We think it could someday be useful for pharma companies running clinical trials.”

Blockchain technology would record every data event that occurs during a clinical trial across multiple ledgers and protect each with cryptographic hashes to prevent tampering. The result is a tamper-proof audit trail that could be viewed and authenticated by third parties such as a regulator or oversight organization.

The system was designed to use a web portal by Daniel Wong, a Ph.D. candidate in Biological and Medical Informatics at UCSF, so that each time, new data in the trial could be immediately submitted. Possible data types include participant vital information, senders, receivers, timestamps, medical information and file attachments — all of which are recorded to the blockchain with its own unique signature.

Unlike other more decentralized blockchains, this one would depend on a central authentication authority such as the U.S. Food and Drug Administration to operate the web portal, register all parties and maintain the blockchain ledger. All of the data, including adverse events, would be reported to the regulatory agency in real time, which could greatly assist with efficiency in communicating information coming out of the trial.

The prototype also makes allowances for errors on the data entry side by allowing amended or modified data to be appended after the fact. However, the blockchain does not allow data to be deleted, so instead of erasing or changing the “bad” data, it would appear that it had been corrected after the fact and still include the previously entered data.

“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 blockchain cannot detect if bad data is being entered into the system by the administrators of the clinical trial, but it can make it more obvious data was tampered with after the fact. Since the blockchain ledger is essentially indelible, even if clinical participants input bad data it would be forever saved that way. However, even that falsified data could be used as evidence to discredit the bad study since it could not be deleted or “fixed” after the fact without making it obvious.

The objective of the prototype is to provide a trustworthy platform for data to be input rapidly with less chances that errors occur on the clerical side (after input). And if data is input more quickly during the trial, it makes it more difficult for deliberate tampering to occur before the data is secured in the blockchain itself.

To test the system, Wong ran the prototype with a small data set from a real clinical trial included in ImmPort, a repository of open data funded by the National Institutes of Allergy and Infectious Diseases that’s managed by Butte’s lab and other collaborators.

After importing the data in a fashion similar to how a clinical trial would use the blockchain web portal, Wong attempted to delete or corrupt the data. In the first instance, the ledger simply appended information that data had been removed without actually removing it from the blockchain. And, in the instance of tampering, Wong tried to change earlier records to show a different medication, and an examination of the blockchain made it obvious where the tampering occurred.

“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.”

The proof-of-concept research on this prototype was published today by UCSF researchers Sanchita Bhattacharya, Daniel Wong and Atul Butte in Nature Communications.

Image: Pixabay

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