The world today is buzzing with the topic of GenAI and while its supporters are abundant, there are of course those who believe that the enthusiasm around GenAI, like most fads, will eventually fade the same way as blockchain’s did. After all, it was only a few years ago that blockchain had taken the world by storm and everyone was talking about how it was the next big thing since the invention of the internet. However, less than a decade on from the peak of blockchain’s popularity, it is a technology that is often talked about as if it’s taboo.
The burst of the blockchain bubble has left many people skeptical of its potential for real world applications with the majority of online discussions on the technology being academic or research oriented. That being said, there is still enough chatter and belief among experts that Blockchain’s day in the sun is yet to come.
As a blockchain enthusiast myself, I will be exploring this claim through a three-part blog series talking about the role blockchain can play in the world of digital health and how it can help address gaps and issues present today. In this first post, I dive into the world of clinical trials and how they can benefit from the use of blockchain.
Clinical trials are often marred by inefficiencies, high costs, data inaccuracies, and trust issues between stakeholders like pharmaceutical companies, researchers, patients, and regulators. This leads to a lot of time and money being spent on verification of data, exploration of trusted partners and tools, and other such steps to establish smooth and streamlined trial operations while ensuring patient safety and regulatory compliance.
This effort of maintaining compliance across a complex and heterogenous ecosystem is one where blockchain can help create a more organized and efficient mechanism to ensure trust is maintained across all stakeholders. Elaborated below are some of the key aspects of how blockchain can help.
Data Integrity and Secure Storage
Clinical trials generate and manage large quantities of sensitive data in the form of patient identifiers, health records, and test results. Ensuring the safety and integrity of this data is not only important to ensure patient privacy and security but also crucial to the success or failure of the trial itself.
Blockchain’s decentralized nature and cryptographic encryption allow for safe storage of data even when present in an ecosystem accessible by multiple parties. Further, since all data transactions on a blockchain network are timestamped and verified by nodes across the network, it ensures that the trial data remains immutable and reduces the risk of data tampering.
Trusted Data Sharing and Enhanced Collaboration
Another data related challenge faced by trial teams is around the sharing of data between different entities. Clinical trials have multiple stakeholders and trust issues between them can lead to problems when data needs to be shared from one party to another.
As described with informed consent above, blockchain can make it so that data sharing can be regulated via the ledger improving transparency and as a result trust between stakeholders. In fact, blockchain can help take it a step further, and similar to the patient registry discussed above, anonymized trial data can be used to help inform other clinical trials of similar natures. This collaborative approach reflects the true strength of a decentralized and ledger-based network and can help with accelerated drug development timelines across the industry.
Improved Consent Management
One of the most complex aspects of a clinical trial is managing informed consent. Once a participant is identified to be eligible, collecting, storing, and managing their consent to the trial is yet another crucial task. The transparency and traceability provided by the blockchain ledger can easily be used to have patients capture a digitized Informed Consent where they can themselves control and log every step of consent, withdrawal, or re-consent.
Enhancing Regulatory Compliance
Maintaining regulatory compliance is one of the most crucial tasks in the administration and oversight of a clinical trial. Trials are subject to high scrutiny by regulatory bodies and are required to strictly abide by the guidelines put in place for them. Not only can smart contracts in a blockchain help to reduce the risk of non-compliance by ensuring the requirements are met in real time, but blockchain based networks can also help provide detailed audit logs with relative ease thus speeding up review processes.
So, does blockchain hold the key to transform and revolutionize the clinical trial process?
There is no denying the potential of blockchain in implementing a more trusted, transparent, and cost-effective clinical trial ecosystem. From streamlined operations to augmented patient experience, clinical trials running on a blockchain network definitely have the capability of being a welcome change for all those involved.
However, while the technology itself does show promise, the biggest hurdle to making this a reality lies in the mindset towards blockchain. For a decentralized network to succeed, multiple stakeholders need to all believe in blockchain as it can only truly flourish when multiple entities collaborate together. And that in turn can only happen once we break the stigma around blockchain and reintroduce the world to the benefits of this technology.
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