Two clinicians, Greg Irving, of the University of Cambridge and John Holden, a General Practitioner – have devised a new system to prevent clinical trial documents being secretly altered to make new medications look more effective than they are.
Dr Irving said:
“Trust in scientific research has been diminished by evidence that some data is being manipulated. The declaration of Helsinki states that every clinical trial must be registered in a publicly accessible database before recruitment of the first subject. Yet despite the creation of numerous trial registries, problems, such as differences between pre-specified and reported outcomes, persist.
Their successful application of this method to a recently reported, randomised clinical trial on cardiovascular diabetes & ethanol, is outlined in a paper that has just passed peer review on open science publishing platform F1000Research.
Undeclared changes to protocols is a major issue in clinical research. If initial analyses show a medication to be ineffective, researchers can continue to analyse new health outcomes until a positive result is found. If only the positive findings are reported, the medication might be mistakenly approved.
Despite an international mandate requiring all trials to be registered before the experiments begin, the problem still persists as universal enforcement is difficult.
A Blockchain is a decentralized database of bitcoin transactions; every transaction is publically recorded, timestamped and stored across a large, international network of computers, making it impossible for the records to be tampered with.
The innovative approach by the two researchers involves converting a clinical trial document into a bitcoin to take advantage its Blockchain infrastructure.
Under their system the original clinical protocol is given a unique digital signature, determined by the document’s text using an online tool called the SHA256 Calculator. This signature is converted into a public bitcoin key using Strongcoin, another online tool, which is then “spent”. This transaction is timestamped and recorded as a Blockchain, multiple copies of which are stored in a computer network.
Anyone who wants to check whether a clinical protocol has been altered can generate a new bitcoin key using the text of the document that they have access to; if this key is different to the one in the Blockchain then this confirms that alterations to the text have been made. This approach has the potential to prevent ineffective or even unsafe medications being distributed to the public.
Blockchain registration of trials could have prevented the infamous Study 329, which erroneously reported that an antidepressant was effective in adolescents. Analysis of the eight original health measures showed the drug was ineffective. However the researchers then analysed a further 19 outcomes and found four to show a positive effect, but only reported these four in the final publication giving a false impression of the drug’s value.
This Blockchain approach is increasingly used in fields such as software development, engineering and genetics. Drs Irving and Holden have broken new ground by successfully applying it to a clinical trial.
Amy Price of Oxford University, who reviewed the article, said:
“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.”
Rebecca Lawrence, Managing Director of the F1000 Group, said:
“Public trust in the medical research community has been severely damaged by evidence of malpractice, including outcome switching, data dredging and selective publication.
“The Blockchain method proposed in this new paper offers a timely and promising solution to these problems. We are pleased to be able to bring it to public attention, quickly and transparently, via F1000Research, where it will no doubt stimulate much-needed debate on this issue.”
F1000Research is an open science publishing platform for life scientists that offers immediate publication and transparent peer review, avoiding editorial bias and ensuring the inclusion of all source data. This process helps scientists to avoid the traditional, anonymous, pre-publication peer-review process that can cause long delays before new results become visible.
All articles must pass an initial in-house quality check prior to publication on F1000Research. Following open, invited peer review where the referee’s name and affiliation and the referee reports are published alongside the article, authors can make revisions that are then published as new article versions.
Since its launch in January 2013, F1000Research has published more than 1000 articles across the life sciences, written by 4,000 authors. For more details on F1000Research go tohttp://www.
- UC Berkeley Opens New Blockchain Lab – Steve Chen Appointed to Co-Lead Newly Formed Berkeley Blockchain Lab - December 10, 2017
- Peter Vessenes Announces Deluge Network To Support a Safe and Direct Way to Contribute Bitcoin Directly to ICOs - December 5, 2017
- EXMO Launches Token Sale with Blockstarter’s ICO Solution - December 5, 2017
- AdHive, A Blockchain-Based Native Advertising Platform, Engages with WINGS DAO Platform - December 5, 2017
- Perkins Coie Adds SEC Attorney in San Francisco with Fintech and Blockchain Experience - December 5, 2017
- Cryptocurrency Monero Announces Breakthrough Online Shopping Initiative Featuring Top Global Artists’ Music and Merchandise - December 5, 2017
- Bitcoin for a ‘bit’ of Caribbean paradise - December 5, 2017
- With the Launch of SunCoin, Solar Bankers Takes On the World’s Energy Giants - December 4, 2017
- Blockchain News Is Merging With Token Report - November 30, 2017
- Mira launches Pre-ICO for Mira – an Easy and Convenient Way to Buy, Store and Send Cryptocurrency - November 23, 2017
- Dash and KuvaCash Partner to Fight Inflation in Zimbabwe with Cryptocurrency - November 22, 2017
- INS Ecosystem Partners with Ambrosus to Overhaul the Grocery Supply Chain - November 22, 2017
- Global Debt Registry Unveils Collateral Pledge Blockchain Proof of Concept - November 22, 2017
- Ripple Appoints Former New York State Superintendent of Financial Services Benjamin Lawsky to Its Board and Ron Will as CFO - November 22, 2017
- Advised by the Co-Founders of YouTube and Twitch, Theta Announces a Blockchain-based Video Delivery Network - November 22, 2017
- Modex adds top advisor from Google ahead of ICO - November 22, 2017
- Decentralized Ad Exchange AdEx Partners with INK to Handle the World’s First Blockchain-based Ad Auction - November 22, 2017
- Zilliqa Lowers Funding Cap Despite Heavy Demand from Investors - November 22, 2017
- Health Startup Etheal Combines Blockchain Technology with Micro-Incentives to Build a Peer-Reviewed Global List of Health Professionals - November 22, 2017
- Bitquence Rebrands as Ethos.io, Charting a Course to Unlock Crypto and the Future of Investment for the Masses - November 22, 2017
- Eidoo Introduces User Friendly ICO Engine – Allowing Crypto Startups To Launch And Manage Their Own ICOs For Fundraising On The Blockchain - November 22, 2017
- Simdaq Launches Social Platform for Democratisation and Development of Cryptocurrency Trading - November 22, 2017
- Gameflip Shatters FLIP Pre-Sale Goals, Sets Sights on December 4, 2017 ICO - November 22, 2017
- Golden Alliance Gold Mining Launches Token Sale - November 22, 2017
- Genaro and Storj Labs Announce Collaboration and Product Integration - November 22, 2017
- Metal (MTL) Now Available on the Chinese Cryptocurrency Exchange - November 22, 2017
- Mark.space & Jaguar Land Rover Announce Cooperation - November 22, 2017
- Exscudo – EON Testnet Was Successfully Updated - November 22, 2017
- Valorem Foundation Launches All-new Cryptocurrency Platform - November 22, 2017
- WAX Partners with Xsolla to Offer Its Platform to More Than 2,000 Video Games - November 22, 2017
- Brave expands Basic Attention Token platform to YouTube - November 22, 2017
- Narrative Launches Blockchain Based Social Network That Puts Revenue In Your Pocket, Not Mark Zuckerberg’s - November 22, 2017
- Gladius Uses Blockchain and Spare Bandwidth to Revolutionize Cyber Security - November 22, 2017
- Indorse Announces Partnership with App Store Cryptocurrency, AppCoins, ahead of MVP Launch - November 22, 2017
- Secutix And The Paléo Festival Nyon Announce The Success Of Their Blockchain Pilot Project - November 22, 2017
- ING launches major addition to blockchain technology: Zero-Knowledge Range Proof solution - November 22, 2017
- Cofound.it Announces Teams Participating in Upcoming Live Crowdsale Event - November 22, 2017
- PUBLIQ goes public: The blockchain and AI company that fights fake news announces the start of its Initial Token Offering - November 22, 2017
- Blockchain for Business SophiaTX Reveals New Details of Platform; Confirms Date for Token Generation Event - November 22, 2017
- BCShop.io Launches Partner Program - November 22, 2017
- World’s First Social Entrepreneurship Platform Moms Avenue Challenges Etsy by Gearing Up With Blockchain - November 21, 2017
- WAX Partners with Xsolla to Offer Its Platform to More Than 2,000 Video Games - November 20, 2017
- Pundi X integrates NEM blockchain to Bring Cryptocurrency Payments Into Retail Stores - November 20, 2017
- Fujitsu Develops Security Technology to Safely Connect Blockchains - November 20, 2017
- Jibrel Network Announces a Highly Successful Pre-sale Round - November 20, 2017
- KRAFTWERK on Blockchain - November 20, 2017
- MintHealth: Empowering Patients to Take Control of their Health and Data via Blockchain Technology - November 20, 2017
- IBM Completes PoC Of Blockchain-based Shared KYC With Deutsche Bank, HSBC, MUFG And Cargill, IBM Treasuries - November 20, 2017
- LetsEnhance.io to process images on Neuromation Platform - November 20, 2017
- Blockchain And AI Researchers Propose A New Model To Return The Control Over Human Life Data To The Patients And Accelerate Biomedical Research - November 20, 2017