Blockchain technology has the potential to maintain the integrity of clinical trial reports and essentially automate trust in the reliability of research findings, according to a recent proof-of-concept study by researchers with the University of Cambridge, U.K.

First used in software development, blockchain is a digital storage system that allows blocks of data, including documents, to be permanently encoded and timestamped. Once a document is added to a blockchain database, third parties can verify its existence and exact wording at a particular point in time. The original document can’t be altered, but revised versions can be encoded, timestamped and added to the chain.  The technology behind blockchain is found in the foundation underpinning bitcoin—a digital currency exchanged via a virtual blockchain ledger that operates independently of any bank or government.

This technology has the potential to provide “an immutable record of the existence, integrity and ownership of a specific trial protocol,” said Greg Irving, a lecturer in the Department of Public Health and Primary Care at the University of Cambridge, and study co-researcher. “It is a simple and cheap way of allowing a third party to audit and externally validate outcomes and analyses specified a-priori with the findings reported a-posteriori.”

Although blockchain technology has been increasingly used in fields such as engineering and genetics, the U.K. study is the first attempt to test its viability in authenticating clinical trial reports, according to the researchers.

For the study, one researcher encoded a trial protocol with a digital signature, using an online calculator called Secure Hash Algorithm (SHA)256  (Xorbin).  The signature was converted into a bitcoin “key.” The conversion process was then timestamped, recorded and stored in a blockchain database, the way a bank deposit or similar transaction would be recorded in a ledger.

To verify the existence of the original document, the researchers used a copy of the original to create a new bitcoin key with the SHA256 calculator. The new key was a duplicate of the first one, and the researchers used it to identify the original, timestamped report record within minutes.  If the second copy of the protocol document had been altered in any way, the second key wouldn’t have matched the first. In fact, when the researchers ran calculations using edited versions of the original document, different keys were generated.

Based on the results, the blockchain concept could help prevent data manipulation and essentially automate trust in the authenticity of published research—a longstanding, widespread problem. In 2005, 17% of authors of clinical drug trials surveyed said they were aware of fabrication in research occurring during the previous decade. With the number of trials published each year steadily increasing from the current rate of 30,000 annually in 2016, manual outcome verification has become virtually impossible, according to the U.K. researchers.

With blockchain technology, making changes to pre-specified text in a document or trying to bury a protocol in a trial registry would be impossible. Although attempts to fraudulently prepare multiple protocols in advance would be technically possible, the effort would involve considerable advanced planning and would leave behind an indelible evidence trail.

In addition, the approach could be used for a wide range of observational and experimental studies for which registries do not exist. The timestamped record could play a key role in solving the persistent problem of protocol registration after trial initiation, and do it with far more speed and precision than would be possible with manual outcome verification.
Given its speed, accuracy and potential for broad applications, researchers also suggest that blockchain technology could help drive the international movement to increase the transparency of clinical trial research.

“The declaration of Helsinki states that every clinical trial must be registered in a publicly accessible database before recruitment of the first subject,” said Irving. “Yet despite the creation of numerous trial registries, problems such as differences between prespecified and reported outcomes persist.” 

Blockchain holds promise to support “automated, extremely robust verification of pre-specified and reported outcomes,” said Irving. “This evidence should increase trust and diminish suspicion in reported data and the conclusions that are drawn.”

This article was reprinted from Volume 20, Issue 21, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »