The new approach, which prevents clinical trial documents from being altered to make new medications look more effective, was developed by Greg Irving, of the University of Cambridge, and John Holden – both practicing doctors concerned about the trustworthiness of clinical trials.
“Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research,” Irving told Outsourcing-Pharma. “Yet, despite the creation of numerous trial registries, problems such as differences between pre-specified and reported outcomes persist.”
To address these concerns, Irvin and Holden applied Bitcoin’s block chain technology to clinical trial reports. A blockchain, which was invented in 2008 to create Bitcoin, is a decentralized database of bitcoin transactions, in which every transaction is publically recorded, timestamped, and stored across a computer network, thus creating a distributed ledger.
“We were aware of reports how distributed ledger technology could provide new tools to reduce fraud, error and the cost of paper intensive processes in other industries and thought it would be interesting to apply this to clinical science,” explained Irving.
According to a report by the UK Government Office for Science, distributed ledger technology “offers the potential to improve health care by improving and authenticating the delivery of services and by sharing records securely according to exact rules.”
“It is a simple and cheap way of allowing a third party to audit and externally validate outcomes and analyses,” added Irving.
How it works
A unique digital signature determined by the clinical trial document’s text, using the SHA256 Calculator, is given to the original clinical protocol. The signature is then converted into a public bitcoin key in a transaction that is timestamped and recorded as a blockchain.
To check whether a clinical protocol has been altered, anyone is able to generate a new bitcoin key using the document’s text. If the key differs to that in the blockchain, then alterations in the text have been made.
According to Irving, a feasibility study would be an important next step. “We hope the approach could be used to strengthen existing clinical trial registries,” he added. “In future, blockchain notary services may be able to simplify and automate the process of study protocol and outcome verification.”
The method’s application to a randomized clinical trial on cardiovascular diabetes and ethanol was recently reported in a paper which has passed peer review on the open science publishing platform F1000Research.