At the start of last year I explored the concept of using blockchain as part of clinical trials, with the idea being that trial data would be stored in a verifiable way on the blockchain. It was prompted by news that pharma giants Pfizer, Amgen and Sanofi were exploring blockchain’s application in the drug development process. The trio were working specifically in the area of candidate recruitment. They hoped that patients who wish to become available for trials can aggregate their data in the blockchain, and thus make it significantly easier for drug companies to find, recruit and retain them in trials.
A new study from researchers at UC San Francisco provides an update on blockchains applicability in drug development. The team have developed a proof-of-concept system to verify and ensure the integrity of the data produced during a clinical trial, which they hope will help to ensure a reliable audit trail can be made.
“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,” the researchers explain. “We think it could someday be useful for pharma companies running clinical trials.”
The system is paired with a web portal to make it easy for administrators to add data to the system. Each entry contains all of the information about the trial, participant and so on, along with a hash of the previous block of data associated with the patient, before being recorded on a new block with its own signature.
Retaining centralized authority
Whilst many blockchain applications are decentralized, clinical trials require the regulator to be the central authority and to therefore be able to not only operate the portal but keep a ledger of all of the blockchain’s hashes.
The researchers proposed system would report all data to the regulator in real time, and whilst new data can be added or previous entries updated, it can’t ever erase what was there before.
“It makes it really obvious when someone’s changing something,” the researchers explain. “You can see who put their hands on it, who made it, who changed it, and who received it.”
The system was put through its paces using data from a previous phase II trial that was published on the open access ImmPort repository. The team tried to manipulate data pertaining to an adverse event experienced by a couple of patients on the trial, but rather than being able to, all they were able to do was add the changes to the original data whilst making a note of who had tried to change the record, when it was done, and precisely what had been changed.
The researchers also tried to corrupt data from an earlier stage in the trial to modify the medication plan the participants were supposedly assigned. As before, it wasn’t possible to do so without all of the above information being captured.
Tamper proof?
Suffice to say, even these safeguards do not mean that the system is completely tamper proof. The authors point out that authentic stakeholders could deliberately or mistakingly enter incorrect information into the system.
Where the blockchain technology helps however is in supporting the use of data exchanges to create a more secure, efficient and transparent environment for all stakeholders, from researchers to the general public.
“A system built upon our prototype could be developed to enable oversight of international clinical trials, for example,” the researchers conclude. “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.”
