Bitcoin tech to improve clinical trial research transparency

By Melissa Fassbender contact

- Last updated on GMT

Bitcoin transactions are verified by network nodes and recorded in a public distributed ledger called the block chain. (Image: iStock/Tsokur)
Bitcoin transactions are verified by network nodes and recorded in a public distributed ledger called the block chain. (Image: iStock/Tsokur)

Related tags: Clinical trial

In an effort to improve transparency in clinical trial research, two doctors created a system that coverts trial documents into a Bitcoin – an online equivalent of cash.

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.

Related news

Show more

Related products

show more

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

What to consider when working with CRFs

What to consider when working with CRFs

Formedix | 21-Sep-2020 | Technical / White Paper

For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention...

Covance Touchless Drug and Device Vigilance Vision

Covance Touchless Drug and Device Vigilance Vision

Covance Patient Safety | 01-Sep-2020 | Data Sheet

Automation tools enable organizations to identify patterns in structured and unstructured data and facilitate automation of the entire product vigilance...

Lessons Learned: Clinical Trials During a Pandemic

Lessons Learned: Clinical Trials During a Pandemic

PCM TRIALS | 01-Sep-2020 | Technical / White Paper

In a recent survey of clinical trial professionals (including pharmaceutical sponsors, CROs, site representatives and vendors), respondents reported that...

Related suppliers

Follow us

Products

View more

Webinars