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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”. […]
