When you see the word “blockchain,” your mind probably jumps to Bitcoin and the cryptocurrency craze. I know mine certainly did. Don’t worry, this isn’t another crypto hype piece. As it turns out, blockchain technology is far bigger than its role underpinning cryptocurrencies. In the words of Aman Khera, the global head of regulatory strategy at Worldwide Clinical Trials and healthcare advisory board member at emTRUTH, “blockchain can be used for anything.”
I recently spoke with Khera about the exciting potential and current uses of blockchain technology in clinical trials, which she spoke about at this year’s DIA conference. Not only does she think blockchain can strengthen the integrity of existing clinical systems (EMRs, EDCs, CTMS), but most importantly, that it can empower patients by giving them more control and ownership of their clinical data. She also sees it as a means of breaking down data silos and improving collaboration in the clinical space.
What is Blockchain?
At its core, blockchain is a tamper-resistant, data encryption technology. The “blocks” are essentially data entries that have been (uniquely) encrypted, timestamped, and verified. Each block contains encryption from the previous block, which ties these data entries together into a “chain,” or ledger that is hard to counterfeit (e.g., inserting an unauthorized block in a chain). The blockchain operates on a distributed network of computers (often referred to as nodes), each maintaining an identical copy of the same database (the chain). Each time a new block is added to the chain, it’s validated across every node in this peer-to-peer network. The blockchain is considered tamper-resistant because in order to change a single data entry, you would need to alter every other block in the chain, across every node in the network, and re-validate the entire chain. According to Khera, this is nearly impossible. Because of this layered encryption, information stored in the blockchain cannot be altered retroactively.
Using blockchain doesn’t mean having to replace your entire IT infrastructure. In fact, “blockchain doesn’t replace anything,” Khera explains. “It enhances existing systems.” Think of it like adding a security plug-in to a web browser as opposed to changing the browser itself. It’s a way of improving both data integrity and transparency, and “making sure the right people have the right data at the right time.”
In a clinical setting, blockchain can be used to securely exchange study materials across institutions and among researchers. These transactions would be timestamped, and the information couldn’t be accessed or altered by anyone outside the blockchain, preventing data breaches. Khera says this has huge implications for interoperability and data sharing.
Imagine a sponsor specifically designing a blockchain-based platform for one of its clinical trials. When a new site opens, the site would immediately gain access to the trial blockchain. Protocols, SOPs, and regulatory documents could all be shared (securely) with the site upon joining, providing site staff with up-to-date access to these important files. This would limit back and forth correspondence with the sponsor and ensure that all sites are operating under the same protocol. The study-specific blockchain could also be used to improve the traceability and transparency of the drug supply chain by keeping a timestamped record of things like the chain of custody or temperature logs.
A secure blockchain would also theoretically make it easier to upload and transmit medical records between practitioners. Gathering medical history can be a bottleneck for patient enrollment. What if a patients’ medical records, or even old PET/CT scans, could be safely uploaded (with their consent) to a blockchain server and shared between hospitals? Integrating this technology into hospitals’ EMR and CTMS systems can help streamline data sharing and expedite patient enrollment.
Reliable Data And Real-Time Monitoring
Data sharing aside, Khera says integrating blockchain use into clinical trials would provide a tamper-proof audit trail for research data. Every transaction or change made to the data would be recorded and verified, ensuring the reliability of results and reducing the risk of data manipulation. This can enable real-time monitoring of trial data, where researchers can track and verify data points as they’re created. From a safety perspective, Khera adds, it can also be used to expedite the identification and reporting of adverse events. It can also reduce the potential for duplicate patient records or identity fraud.
Power To The Patients
While blockchain’s improvements to the operability of clinical trials is a fun selling point, Khera’s most passionate about its potential to empower patients. One way she’s seen this being done is by keeping patients’ informed consents on the blockchain. She says storing consent records on the blockchain gives patients more control over their data, “granting or revoking researchers’ access as needed.”
Data privacy is a growing concern, and Khera believes in using blockchain to not only protect patient data, but to grant them ownership of it. Giving patients access to the study blockchain would let them see how their data is being used, and this transparency could strengthen their trust in research. It would also allow them to access their test results (e.g., bloodwork, MRIs, and PET/CT scans), which they can then easily share with their primary physicians. Letting patients access this data directly instead of going through an administrative labyrinth would strengthen their sense of control and ownership. As Khera says, “if we give patients that empowerment, then they’re more likely to go onto a clinical trial and stay on the clinical trial.”
Blockchain can further improve the patient experience through it’s use in decentralized clinical trials (DCT). Allowing patients to access a study’s blockchain remotely through their own devices would make it easier for them to complete questionnaires or drug logs for participation in DCTs. It would also benefit the sponsor, who wouldn’t need to provide these devices to patients.
Khera says blockchain can also enable more effective reimbursements for study participants. You can cut administrative costs by using blockchain to automate payment processes, thus eliminating the need for intermediaries.
Where Are We In The Adoption Curve?
With these wide range of possibilities, you may be asking, why isn’t blockchain use exploding in the clinical space? Khera says the simple answer is a general lack of awareness. There are ongoing pilot projects and initiatives focusing on the proof-of-concept and feasibility of using blockchain to enhance clinical operations. These initiatives involve various collaborations between pharma companies, CROs, technology providers, and regulatory bodies.
Other barriers currently hindering the widespread adoption of blockchain in clinical trials include scalability issues, as well as concerns with interoperability, regulatory uncertainties, and integration into existing systems. “Not everyone wants to be an early adopter,” she says, “and a lot of people don’t want to be fast followers in this either, so they’re just kind of playing wait and see.” She says continuing these pilot initiatives to address concerns and establish guidelines and standards for implementation are an important step towards wider adoption.
Khera says a lot of large pharma companies are already looking into using blockchain technology in clinical operations. As an industry, we need to start sharing our experience using blockchain — the wins and the losses. “Only through collaboration in our industry can we move forward together,” she says. According to Khera, these pilot programs can be run using existing datasets. There’s no magic solution that will cure all the inefficiencies of clinical trial operations, and blockchain is certainly no exception. “While it may not be the golden ticket,” Khera says, “it can help.”