Is Blockchain The Solution To Derisking Unreliable Clinical Trial Data?
By Federico Turkheimer, PhD, King’s College London and LabTrace, and Eric Wragge, Algorand Foundation
Innovation and trust in said innovation are key to a healthy and active clinical trial ecosystem. This pairing drives the progression of new treatments to the clinical trial stage and the enthusiastic volunteering of patients to join these trials. This pairing also makes the treatment possible in the first place, as the data of scientific researchers in the near and distant past are relied upon by their peers in the present.
At the same time, the tsunami of new data generated by novel medical technologies, like expanded testing for biomarkers, has led to several foundational discoveries. These discoveries (and the treatments they inform) hold great promise for patient care. But where innovation arrives, trust must follow.
Unfortunately, these technologies are increasingly vulnerable to plagiarism, falsification, and fabrication. Scientific fraud has existed for as long as science has, but the newest numbers demonstrate a four-fold increase in the rate of retracted papers in Europe in the last 20 years. Alarmingly, the reasons for retractions have also changed. While in 2000, most retractions were due to ethical and legal problems or authorship issues, now the same proportion is caused by unreliable data.
The growing concern has prompted actions from government funding agencies and charitable foundations. There are several possible solutions, like more intensive training on professional codes of conduct for researchers and discipline-specific guidelines (and consequences). The UK Concordat to Support Research Integrity is a great example of these efforts. Similarly, the British Neuroscience Association launched credibility toolkits, which mostly rely on project pre-registration that consists of clearly and openly stating one’s experimental rationale, hypothesis, and methods (including the sample size and what statistical analyses are going to be used, before conducting the experiment).
These are great initiatives and should continue so as to stop inaccurate or unethical research from ever beginning. However, they do not serve treatments and trials underway in the present. To continue, these trials need data that can be trusted. And in truth, they need data that can be trusted by a wide audience. It can be complex and time-consuming for a trained researcher to evaluate the body of work on which an experimental treatment is based. But now that concerns about rising scientific fraud are mainstream, methods or data verification have to be mainstream as well.
The ideal would be to have an easily navigable record of the data’s provenance and authenticity. CROs or regulators could have access to a ‘stamp of approval’ stating that the data has been reviewed, confirmed, and not retracted — a sign that it can be trusted. This kind of secure record was not possible in the past, but it is today with blockchain. Clinical trials could benefit from using blockchain in their experimental workflow as a novel and effective tool to ensure integrity in the process.
A blockchain is a distributed public ledger that is immutable and held by a very large network of participants (nodes). Nodes in the network continuously verify the correctness of the ledger and grow the same ledger through a consensus protocol that adds records (also called blocks) that are securely linked together via cryptographic hashes. While blockchains are associated in the popular press with cryptocurrencies, they more fundamentally function as databases that can be used to securely and immutably record history.
For example, once a file is uploaded to the platform on a given blockchain, a file identifier (content-hash) is created that is uniquely linked to the file content. The hash is then written to the blockchain together with any relevant information. The user receives a certificate containing the hash, the ancillary information, and the link to the block in the ledger. While the certificate remains public, the user has the option of either publishing the file or keeping the file private within its own firewalls (the whole process is GDPR compliant); in the latter case, proof of true certification can be provided at any time.
The flexibility of the platform allows the recording of a unique data identifier for any type of file at a certain time (timestamp) and the sharing of proof of its veracity (certification). The platform also allows the creation of a chain of evidence with secondary data (those data that are obtained from raw data, like images, through some software). The product(s) of such processing, which we call secondary files, can then be linked via the blockchain to the primary data and the software used. A reviewer can easily inspect these chains of evidence.
In summary, while recent technological advances may have provided fertile ground for new types of scientific fraud, novel technologies can also be effectively used within an ethical framework to guarantee a transparent and certified process for experimental science. Furthermore, there are now second-generation “green” blockchain systems (e.g. those with a low carbon footprint), which alleviate concerns about the extreme energy requirements of earlier blockchain systems. As we have explained above, it is also easier than ever to embed blockchain into proprietary systems. For this reason, we are confident that blockchains represent the best approach to embedding trust into notarized scientific systems.
Scientific research requires trust, whether in a lab or a clinical trial. Designers of clinical trials must rely on their colleagues' results from across the years to create and then pursue approval for their novel therapeutics and treatments. That trust is then transferred to the relationship between clinical trial designers and the patients who volunteer to join their trials. And when a trial is successful, that trust is provided to all of us — anyone who may benefit one day from a discovery. The steadfastness of data is relevant to all of us. Therefore, its integrity should be accessible to all of us as well.
About the Authors:
Federico Turkheimer PhD is a neuroscientist and professor of neuroimaging at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London, where he is director of the KCL Institute for Human and Synthetic Minds. He is also the director of LabTrace, a technology startup seeking to bring secure and GDPR-compliant data traceability to clinical trials and medical research.
Eric Wragge is the global head of business development at the Algorand Foundation, an organization dedicated to supporting the developer ecosystem by creating impactful, secure, scalable real-world blockchain applications on the Algorand blockchain.