Two clinicians have devised a new system to prevent clinical trial documents being secretly altered to make new drugs look more effective than they are by using a similar system as the digital currency of bitcoin.
Reporting in F1000Research, the doctors said that “undeclared changes to protocols is a major issue in clinical research.”
This is because if initial analyses show a medication to be ineffective, researchers can continue to analyse new health outcomes until a positive result is found. But 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. Lobby groups, such as the U.K.-based AllTrials, are now trying to open up the availability of data, but major gaps still remain.
So the doctors turned to bitcoin–a type of digital currency in which encryption techniques are used to regulate the generation of units of currency and verify the transfer of funds, and operate independently of a central bank.
What interested them about this system is that its blockchain is a decentralized database of bitcoin transactions: This means that every transaction is publicly recorded, timestamped and stored across a large, international network of computers–making it impossible for the records to be tampered with.
In their paper, Greg Irving of the University of Cambridge and John Holden, a family doctor, describe how they converted a clinical trial document into a bitcoin to take advantage its blockchain infrastructure.
Under their system, the original clinical trial 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 trial 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 from 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, with the doctors adding that blockchain registration of trials could have prevented the infamous Study 329–which erroneously reported that an antidepressant was effective in adolescents.
Analysis of the 8 original health measures showed the drug was ineffective. However, the researchers then analyzed 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–but is now being considered in the clinical trial space.
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.”
Dr. Rebecca Lawrence of the F1000 Group added: “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.”
– check out the research paper