GP and academic use blockchains to prevent clinical trial documents being secretly altered
Two clinicians have devised a new system to prevent clinical trial documents being secretly altered to make new medications look more effective than they are.
The new method aims to solve this problem using blockchains, the technology that underpins the virtual currency, Bitcoin.
Their successful application of this method to a recently-reported, randomised clinical trial on cardiovascular diabetes and 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 decentralised 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.
Trust in scientific research has been diminished by evidence that some data is being manipulated
The innovative approach by Greg Irving of the University of Cambridge, and John Holden, a GP, involves converting a clinical trial document into a bitcoin to take advantage of 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 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 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.
Despite the creation of numerous trial registries, problems, such as differences between pre-specified and reported outcomes, persist
Drs Irving and Holden have broken new ground by successfully applying it to a clinical trial.
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.
Amy Price of Oxford University, who reviewed the article, added: “Blockchain improves and expands the role for trial registries or publishing protocols. The approach could be used for Randomised Controlled Trials and a whole range of observational and experimental studies where registries are needed but do not currently exist.”