By Federico Turkheimer, PhD, King’s College London and LabTrace, and Eric Wragge, Algorand Foundation
Innovation and trust in that innovation are essential to a healthy and active clinical trials ecosystem. This association fosters the progression of new treatments into clinical trials and the enthusiastic volunteering of patients to participate in these trials. It also makes the treatment possible in the first place, as data from scientific researchers of the near and distant past are used by their peers in the present.
At the same time, the flood of new data generated by new medical technologies, such as expanded testing for biomarkers, has led to several fundamental discoveries. These discoveries (and the treatments they influence) hold great promise for patient care. But where innovation comes, trust must follow.
Unfortunately, these technologies are increasingly vulnerable to plagiarism, falsification and fabrication. Scientific fraud has been around for as long as science has, but the latest figures show that the rate of article retractions in Europe has quadrupled in the last 20 years. Alarmingly, the reasons for retractions have also changed. While in 2000, most retractions were due to ethical and legal issues or questions of authorship, today the same proportion are due to unreliable data.
This growing concern has prompted government funding agencies and charitable foundations to take action. There are several possible solutions, such as more intensive training on codes of professional conduct for researchers and discipline-specific guidelines (and their consequences). The UK Concordat for Supporting Research Integrity is a prime example of such efforts. Similarly, the British Neuroscience Association has launched credibility toolkits, which rely primarily on pre-registration of the project, which involves clearly and openly stating the rationale, hypothesis, and experimental methods (including sample size and statistical analyses that will be used, before conducting the experiment).
These initiatives are excellent and should continue to stop inaccurate or unethical research. However, they do not serve the treatments and trials that are underway. To continue, these trials need reliable data. And in truth, they need data that is reliable for a broad audience. It can be complex and time-consuming for an experienced researcher to evaluate all the work on which an experimental treatment is based. But now that concerns about increasing scientific fraud are widespread, the methods or verification of data must be as well.
The ideal would be to have an easily searchable record of data provenance and authenticity. Contract research organizations or regulators could have access to a “stamp of approval” indicating that the data has been reviewed, confirmed, and not retracted, a sign that it is trustworthy. This type of secure record was not possible in the past, but it is now thanks to blockchain. Clinical trials could benefit from using blockchain in their experimental workflow as an innovative and effective tool to ensure the integrity of the process.
A blockchain is a distributed, immutable public ledger held by a very large network of participants (nodes). The nodes in the network continually verify the accuracy of the ledger and expand it 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 function more fundamentally as databases that can be used to record history in a secure and immutable way.
For example, once a file is uploaded to the platform on a given blockchain, a file identifier (content-hash) is created and is uniquely linked to the file content. The hash is then written to the blockchain along with all relevant information. The user receives a certificate containing the hash, auxiliary information, and the link to the block in the ledger. While the certificate remains public, the user has the option to publish the file or keep it private within their 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 given time (timestamp) and the sharing of proofs of its veracity (certification). The platform also allows the creation of a chain of evidence with secondary data (those obtained from raw data, such as images, using software). The product(s) of this processing, which we call secondary files, can then be linked via the blockchain to the primary data and the software used. An examiner can easily inspect these chains of evidence.
In summary, while recent technological advances may have provided fertile ground for new types of scientific fraud, new technologies can also be effectively used within an ethical framework to ensure 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 previous blockchain systems. As we explained above, it is also easier than ever to integrate blockchain into proprietary systems. For this reason, we believe that blockchains represent the best approach to embedding trust into notarized scientific systems.
Scientific research requires trust, whether in a lab or in a clinical trial. Clinical trial designers must rely on the results their colleagues have achieved over the years to create and approve their new treatments and therapies. That trust then flows into the relationship between clinical trial designers and the patients who volunteer to participate in their trials. And when a trial is successful, that trust flows to all of us—to all of those who might one day benefit from a discovery. The trustworthiness of data is a concern for all of us. Therefore, its integrity must also be accessible to all of us.
About the authors:
Federico Turkheimer is a neuroscientist and Professor of Neuroimaging at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, where he is Director of the KCL Institute for Human and Synthetic Minds. He is also Director of LabTrace, a technology start-up seeking to bring secure, 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 building impactful, secure, and scalable blockchain applications on the Algorand blockchain.
