While we are all aware of the disruptions in the fintech industry brought about by blockchain technology, have we taken notice of how it has inspired the life sciences industry with achievable and some speculative deliverables? In this blog post, we will try to dissect some of the challenges faced in clinical trials and how blockchain technology can provide us with the answers.
Use Case 1: The US Food and Drug Administration requires the sponsor of the clinical trial or the principal investigator of a clinical trial to register the trial and report trial results and associated information in public repositories. But the compliance to the mandate is very low. Over and above, there are cases of data manipulation. A study by Seife C, which analyzed hundreds of clinical trial FDA inspection documents covering the 1998-2013 period, showed that a substantial number of them presented evidence of research misconduct, more than half of which were related to the failure to protect the safety of patients and/or issues with oversight or informed consent. Blockchain technology can bring in accountability and transparency into the reporting process of clinical trials, providing secure and synchronized data submission. The chances of data fraudulence reduce since every sequence of report submission is immutable and tamper-resistant. As a result, we will get an auditable and indisputable record of information.
Use Case 2: Blockchain technology can be used to create an inconvertible digital ledger to document the single point of origin of a compound or a substance and various compositional changes it goes through due to testing and approvals. Since the information resides within the decentralized framework, the management, administration, and security of data is now shared among the participants and there is no need of central server or agent to trust. This helps the life sciences organizations to continue to focus on their core practices without having additional concerns over data management, data origin, and data ownership. This approach will also provide more scalability and security than the prevalent centralized architecture with CROs. Also, in cases of global studies, data is collected from several labs across multiple countries. These data points need to be shared in an anonymized way, provided the information is traceable in case of adverse event reporting. Managing the final version and completeness of this data as well as tracking the status and return of clinical kits, blockchain technology can come as great help.
The study protocol, including the planned analysis and clinical outcomes it was supposed to test, can be ‘hashed’ in the block and publicized on the blockchain technology. The hyper ledger blockchain system may have the following touchpoints:
- High-resolution photos of medical reports
- Trial protocol
- Biological results
- Informed consent forms
- Certificate of authenticity from the PI
- Real-time record of every submission
- Record details
The Blockchain technology also provides cost-effectiveness by freeing up capital inflows, speeding up processing, and lowering the transaction cost.
Use Case 3: ‘Smart Contract’ in Bitcoin technology
Smart Contract can be described as a piece of code which is stored in the blockchain network. It defines the condition to which the all parties adhering to the contract agrees. If the required conditions are met, then certain actions get executed. The lack of interoperability when it comes to managing trial reports is not a secret. Smart Contracts can play a big role here. It can streamline processes for trials, improve access to cross-institution data, and can increase confidence in patient privacy.
Another benefit of introducing the blockchain applications to clinical trial could be that the study protocols can be kept under cover until the study has been completed. This may help in safeguarding sensitive trials of new therapies. The public key can be uploaded to the registry on the offset of the trial so that the protocol can be verified later without any concern about the study protocol being tampered with.
Last year, an American multinational technology company headquartered in New York had signed a research initiative with the FDA to define a secure, efficient, and scalable exchange of health data using blockchain technology. They will explore the exchange of owner-mediated data from several sources, such as EMR, clinical trials, genomic data, and health data from mobile devices, wearables, and IoT. The initial focus will be on oncology-related data.
On November 2017, Imperial College London hosted Blockchain Hackathon in Clinical Trials. During the hackathon, the main effort was to replace CRO operations with blockchain technology. The two finalists of the hackathon proposed using distributed ledger technology to operate all the transactions necessary between the pharma companies (the sponsor) and the clinical trial sites using blockchain network.
In an IBM report called “Healthcare Rallies for Blockchains – Keeping Patients at the Center,” conducted among 200 healthcare executives in 16 countries, 70% expect the greatest benefits of blockchain to be in clinical trial records, regulatory compliance, and medical health records.
In March 2016, the Computerised Life Events Assessment Record (CLEAR) project announced that it had begun recording information relevant to blockchain clinical trials on the MetroGnomo mutual distributed ledger.
Blockchain technology in healthcare heralds a major opportunity for clinical research. It can provide a proper structure to the huge influx of reports garnered from mobile devices, social network, and IoT data, consolidating the efforts of researchers and patient communities. We believe that there are many other possibilities for this powerful technology, which are yet to be discovered.