Researchers at the University of California, San Francisco (UC San Francisco) have devised a new approach that leverages blockchain technology to maintain the integrity of clinical trials data.
The new system generates an immutable audit trial to allow easy identification of any alterations to the trial results, noted the university.
Blockchain involves creation of a unique digital signature called hash for each ‘block’ of data.
Under the new system, which operates through a web portal, each new data entry about a trial participant will be recorded onto a new block with its unique signature.
Along with the participant data, the sender, receiver, timestamp and the data file attachment as well as the hash of the previous data block of that particular patient will be recorded onto the new block.
Majority of blockchain applications are decentralised, while the new prototype is set to have a centralised regulatory authority such as the US Food and Drug Administration (FDA) to operate the web portal, register all involved parties and maintain a log of the blockchain’s hashes.
The researchers expect that this approach of reporting data to the regulatory authority in real time would increase the safety and efficiency of clinical trials.
In addition, the blockchain-based system only allows changes or corrections to the existing data chain, without any deletions.
UC San Francisco biological and medical informatics PhD candidate Daniel Wong said: “It makes it really obvious when someone’s changing something. You can see who put their hands on it, who made it, who changed it, and who received it.”
The new system was evaluated using a small data subset from a previous Phase II trial included in a National Institutes of Allergy and Infectious Diseases (NIAID)-funded open clinical trial data repository called ImmPort.
When Wong logged into the new system as trial sponsor and tried to make any type of changes to the original data, the system appended his changes rather than deleting the available data.
The researchers noted that the new system could mitigate integrity risks but does not completely protect data from tampering.