Two doctors have recently devised a concept that makes clinical trial documents immutable using blockchain technology. A universal method of keeping clinical research untampered is an issue within the medical field. Often these trials can be manipulated, and the resulting treatment and medication can be over-exaggerated.
A Peer-Reviewed Clinical Trial Blockchain Proof-of-Concept
Because of these issues with scientific corruption, John Holden, a General Practitioner, and Greg Irving of the University of Cambridge have applied a better form of authentication to a clinical trial submission using a decentralized database as its proof-of-concept.
Blockchain technology is an excellent way to distribute data and assets with time stamped cryptographic assurance. The researchers say that distributed ledger technology has been applied to finance, software development, genetics, and engineering, but until now it’s never been tried with clinical trials.
The clinicians have outlined this concept with a report in cardiovascular diabetes and ethanol research, and it has passed a peer review on the F1000Research website. The authors of the proof-of-concept explain how they managed to apply the research paper to the blockchain in their report:
A copy of the clinicaltrials.gov study protocol was prepared based on its pre-specified endpoints and planned analyses which was saved as an unformatted text file. The document’s SHA256 digest for the text was then calculated by entering text from the trial protocol into an SHA256 calculator. This was then converted into a bitcoin private key and corresponding public key using a bitcoin wallet.
Boosting Research Credibility
Manipulated and fraudulent scientific research is all too common these days, eroding “confidence in medicine as a whole which is essential to the performance of its function,” says the clinical researchers. The clinicians say that using distributed ledger technology allows a simple and cheaper way of being confident in a peer-reviewed scientific method without the need for third-party arbitration. The report states, “Transaction codes could be recorded in scientific papers, reference databases or trial registries to facilitate external verification. Making changes to pre-specified text in a document or trying to bury a protocol in a trial registry would simply not be possible.”
However, the paper describes a method of fraudulently-prepared multiple protocols that could very well be used in an ill-mannered fashion. Researchers explain, though, that such an attack would take tremendous amounts of planning and would leave a public trail of immutable evidence.
Amy Price of Oxford University gave her peer review of the paper, and this is what she had to say:
Blockchain improves and expands the role for trial registries or publishing protocols. The approach could be used for Randomized Controlled Trials and a whole range of observational and experimental studies where registries are needed but do not currently exist.
The paper also explains that the text of the document can be verified by generating a new public key so anyone can check to see if the peer review is legitimate. The research states, “if the key is different to the one in the blockchain then this confirms that alterations to the text have been made.”
A digital ledger such as the blockchain could have prevented quite a few misleading medical findings over the past couple of years. This includes when publisher Springer had to retract 64 articles in 2015 from its journals. Sister company BioMed Central later removed 43 articles for fraudulent findings within the researched data.
With a large amount of these manipulated papers being found in medical trial data, practitioners are losing faith in the system. Dr. Marcia Angell, a physician and long-time Editor-in-Chief of the New England Medical Journal gave her opinion last year saying:
It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.
Dr. Irving believes the proof-of-concept he and his partner assessed is groundbreaking for clinical trials. The practitioner says that trust in research has been “diminished,” even with the current regulatory standards involved with clinical research. Dr. Irving concludes his paper by saying blockchain verification “should increase trust and diminish suspicion in reported data and the conclusions that are drawn.”
What do you think about John Holden and Greg Irving clinical blockchain proof-of-concept? Let us know in the comments below.
Images via Pixabay and Shutterstock.
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