Don and Alex Tapscott, authors of Blockchain Revolution (2016), define blockchain as an “…incorruptible digital ledger of economic transactions that can be programmed to record not just financial transactions but virtually everything of value”.
Blockchain has been a talking point for many years, but with the maturity in public and private blockchain frameworks – Hyperledger Fabric and Ethereum, respectively – in 2016, further demystification of the technology, and more use cases getting discussed, it came into focus in 2017. Its inherent positive properties such as data security, privacy, reliability, and interoperability are creating excitement and impacting business in several areas.
I have previously touched upon this topic in a white paper (written along with my colleague Suhas J) titled ‘Harness Abundance the Blockchain Way’, with a focus on supply chain management. This time around, I will explore the versatility of blockchain in the context of life sciences and healthcare. The emphasis will be on tackling problems in the area of clinical trials, building trust, improving compliance, and enhancing efficiency.
Hurdles in Clinical Trials
Clinical trials are comprised of multiple phases, with each phase involving several stakeholders exchanging a variety of data related to drugs, patient health, collected samples, etc. This is in addition to the exchange of physical material such as drugs, sample tubes or vials, and medical apparatus and devices, among other things.
The clinical trial process must align with a well-defined and pre-agreed protocol from the very beginning. The average clinical trial can take anywhere between three to seven years, and therefore has major cost implications for the sponsor and the drug manufacturing company. Tufts Center for the Study of Drug Development has released an assessment of the high cost to develop and win marketing approval for a new drug.
Fraud in the clinical trial process is not uncommon, since the final goal of the drug manufacturer is to earn millions from the drug being tested. Consequently, there is a tendency to cut short processes and expedite the trial by fudging data without adhering to protocol and procedures.
A massive amount of data is produced and consumed during the entire clinical trial process. This includes statistics related to patient health and drug dosage, pathology and radiology reports and images, surveys, data related to medical devices and instruments, as well as safety and quality reports. All this data is consumed across a diverse set of stakeholders, including clinicians, doctors, facility administration, regulatory bodies, sponsor, and the pharma company itself.
With so many parameters making up the data supply chain, errors can happen either by mistake or intentionally. Fraud typically involves hiding or misreporting critical data points (fudged consent forms or altered trial results) in order to expedite the process, or to save face. Moreover, the protocol may not be shared with all the stakeholders, or may even be altered during the trial to favor a positive result.
Blockchain to the Rescue
Blockchain can play an important role in this data supply chain. From the very start, the protocol for the trial must be clearly defined and related data must be captured and simultaneously disseminated to all stakeholders, including the audit and regulatory authorities. Being part of the Blockchain network will ensure no aspect of the protocol is tweaked at a later point to suit one or more parties. As the trial progresses, the blockchain captures all potentially vulnerable data, be it the movement of drugs, supplies, medical devices or equipment used during the trial, or the generation and sharing of reports.
The integrity of the data thus becomes irrefutable and the need for steps such as source data verification become redundant. The adoption of blockchain and bringing all the different stakeholders into the network together with the clinical data management system will further speed up the clinical trial process and result in early decision-making with zero (or minimal) chances of manipulating the results. Smart contracts can also be used as ‘toll gates’ to verify the completion of a phase before the subsequent phase kicks off. This can be practiced across the three clinical trial phases and could also be used between phases at specific milestones.
To summarize, blockchain is a major opportunity for the clinical trial process – right from logging trial protocols and amendments to the protocol, to capturing all data flows across the different phases of the clinical trials, to even the point when the trial moves into the regulatory approval phase. The usage of Blockchain in the process will not only make the process transparent to the patients and all other stakeholders, but will also create efficiency, reduce the lengthy time period of trials, and bring in reliability while maintaining security and privacy.