The past two years have dramatically changed the clinical trial industry. Trial sponsors and clinical research organizations have embraced remote trials and other creative solutions because of the pandemic. However, there are additional forms of technology that can drive trials forward while allowing firms to maintain regulatory compliance.
Here is how blockchain is used in clinical trials to protect sensitive data and maintain data integrity.
At its core, blockchain is a system to track records and create a clear path of understanding regarding any changes a set of information went through.
“Blockchain is, in simple terms, a transaction record,” says Rama Rao, cofounder and CEO at clinical trials management and financial system platform Bloqcube. “It is a record that is immutably stored and linked up cryptographically, so that there is a single source of truth over a period of time thus engendering trust. As a result, the record can be relied upon by multiple parties, in the absence of any other processes.”
This single source of truth is essential in clinical trials. If any data has been tampered with, it likely cannot be used in publication. If data sets or versions are confused, then hours (or even months) of research can be lost. Blockchain works to create one reliable version of data.
“Blockchain consists of n nodes that are linked together in a cryptographically protected manner,” write researchers Peng Zhang et. al in Frontiers in Blockchain. “During the formation of the chain, each node consists of data provided by some client application (such as a name or other personal data) and a cryptographic hash of the data in the node that precedes it.
Together, these properties use the information stored in the [public, distributed ledger]…to produce a long string of letter and number combinations that represents a snapshot of that data that is computationally infeasible to reverse and also proves mathematically that the data is unaltered.”
The cryptographic hash of the data in the node protects patient privacy along with ensuring the quality of the data. Researchers can move forward with their data knowing that it is accurate and unchanged. This also makes troubleshooting problems easier.
“Blockchain data integrity has the strength of cryptographic validation of each interaction or transaction, and the entirety of the set of records,” writes the team at Astrix, a professional services and staffing provider for science-based organizations. “Any data integrity issue in a blockchain results in an immediate indication of where and when the problem happened, along with the contributor of the offending transaction.”
Essentially, clinical trial tools with blockchain data management can help researchers protect their data to ensure it is fit for publication.
Better data security has other benefits across the clinical trial landscape. Patients can also benefit from knowing that their information is secure through blockchain.
“Patient privacy issues and the intellectual property of trial sponsors are of paramount concern in any clinical trial,” write Charles Wright and Rakesh Joshi, technical director and researcher, respectively, at innovation consulting firm PreScouter. “Not all participants in a clinical trial need to be privy to either sets of data.”
One of the challenges facing the use of blockchain is the creation of different data permission levels, or nodes, for each group of people. These groups range from patients to healthcare providers to the researchers themselves. However, the transparency of blockchain helps with data breaches so researchers can quickly identify issues.
“Blockchain technology can keep track of every change, such as its content, people, and time of modification – details that could be crucial during clinical trials,” says Frank Leu, CEO at preclinical biopharmaceutical company Novapeutics. “It allows exchange of data between laptops, smart phones, computers, servers, and internet-connected instruments and equipment, without having to reply on email or other unsecured methods.”
This flexibility ensures security without compromising the value of data sharing.
With the use of a blockchain ledger, clinical trial researchers can also increase the checks within their organizations to make sure their trials are completed ethically and with transparency.
“Let us consider randomization of a patient in a clinical trial before written consent: this violates basic ethical requirements and could be prohibited with a Smart Contract,” researchers Mehdi Benchoufi et al. write in an article in Frontiers in Blockchain.
Instead, through a blockchain system, researchers can use if-then statements, in which a patient cannot be assigned randomization unless they have signed the proper consent forms. This process would use technology to prevent ethical breaches.
“Using blockchain, we can trace if and when consent was given, we can bind a consent to a document, for instance, a study protocol, on any of its versions, the proof of which are stored in the blockchain through the so-called hashes,” write Sebastian Porsdam Mann et. al in the Journal of Medical Ethics.
Blockchain can also help with patient recruitment. Researchers can better identify qualified patients without compromising the privacy of those involved.
“Blockchain technology will be able to directly increase the quantity and quality of patients recruited for clinical trials in a number of ways,” says Gunjan Bhardwaj, CEO of AI and blockchain solutions provider Innoplexus. “This type of distributed ledger could allow individual patients to store their medical data by anonymous methods, thereby making it visible to trial recruiters, who could then reach out to the patients if their data qualifies for the clinical trial.”
Blockchain has the potential to create a better patient experience, extending its value beyond the data management systems and compliance regulations of researchers.
Clinical researchers have overcome countless challenges in the past two years. Embracing the opportunities presented through blockchain seems like the next logical step.
“In the midst of a global pandemic, pharma regulators (who have arguably been slow to accept technology adoption in the past) are now more than ever likely to acknowledge the need for change and acceptance of digital endpoints in clinical trials,” writes the team at merger and acquisition advisory firm Results.
However, there are limits that can prevent researchers from fully investing in blockchain technology for improved trials. These range from a lack of developed skills to slow industry adoption.
“Despite the promising value proposition of blockchain technology in clinical trials, broad adoption will require the industry to overcome technological barriers, including scalability and interoperability across different blockchain solutions, as well as non-technological barriers such as the cross-functional development of blockchain knowledge, skills, and regulatory frameworks,” write Baldwin C. Mak, et. al in an article for Blockchain in Healthcare Today.
For many, blockchain is primarily discussed in the financial sector as a way to protect various funds and investments. The system can also improve how researchers collect, sort and manage data. It can increase security and improve the patient experience.