Though the Covid-19 pandemic rages on across the world, a series of vaccines manufactured by leading pharma companies are shining a light at the end of a very long tunnel. The novel coronavirus has been with us for over a year now, and though likely that it will never be eradicated, vaccines will go a long way towards suppressing the danger for extended periods. Of course, a new, more virulent organism might rise from the primordial jungle or an animal host at any time. It is up to us, mankind, to keep a watchful eye on any emerging outbreaks around the globe.
Vaccination programs are the more visible aspect of a very long process that begins with research, which in turn leads to experimentation, and eventually the testing of a drug in animals first, and then in human clinical trials. These trials are the cornerstone of medical research, as they enable the testing of potential treatments in a range of human volunteers. Blockchain technology does have a part to play in clinical trials, and we’ll be discussing that in just a moment.
In this piece, we’ll discuss the role of blockchain in clinical trials, and we’ll also talk about how decentralized ledger technology can become the foundation for a solid supply chain structure.
Blockchain: A decentralized solution for the future of clinical trials
Data management in clinical trials
Clinical trials are essential to determine the safety and viability of new drugs intended to enter the market, or to find alternative uses for drugs that are already commercially available.
Pharmaceutical trials generate a vast amount of data, and meaningful collection and interpretation of such data is crucial to determine the integrity and validity of the outcomes.
The problem arises when trying to manage medical records, patient-reported data, drug safety and dosage parameters, data arising from biological samples, and data coming from many other sources. There is a lot of information available, and investigators are partial to taking the somewhat misguided ‘more is better’ route. This blunt approach often places a burden on trial participants in the form of countless and repetitive questionnaires, multiple sample taking, and other annoyances at times when the subject’s health may be in serious jeopardy. And furthermore, much of this data might never be looked at, analyzed, or used in any way.
The collection, analysis, and validation of clinical data is therefore an inherently complex and costly process that involves a lot of moving parts, which quickly becomes its own Achilles’ Heel. There are simply too many sources and many ways in which data can be misinterpreted or maliciously altered or misused.
Take Case Report Forms (CRFs) and patient diaries, for example. These are usually paper-based data collection methods that are still widely used today. CRFs are normally specific to each trial, and are utilized by hospitals, or whatever institution is running the trial, to collect patient data. Patient diaries are given to study participants so they can record medicine intake times and doses, any worsening of symptoms, etc.
CRFs and patient diaries are perfect examples of the inefficiencies currently faced by clinical trials, as both methods rely on hand-written notes from either patients or study staff. Either way, these notes can contain ambiguity, which might lead to being misread or misinterpreted, potentially compromising the study outcome and/or patient safety. Paper-based data is costly and awkward to store and manage, and can easily be misplaced or tampered with, which casts heavy doubts about its validity and reliability in a clinical setting.
Overall, only one in ten drugs being tested actually makes it to market. This is a huge failure margin, which means a lot of time, effort, assets, and data being wasted in the process.
Blockchain as a solution to clinical data management
Clinical trials pose challenges, due to their very nature. Blockchain technology can address some of them.
At its core, blockchain is a decentralized ledger that does exactly what it says on the tin. It is a chain of blocks that stores transactional data. All existing nodes in the network validate the transaction, which becomes immutable, i.e., it cannot be changed. Simple, yet incredibly powerful and versatile. Many industries such as manufacturing, fintech, entertainment, supply chain, and many more have already benefited from blockchain-powered platforms.
The current workflow of data during the lifespan of the clinical trial is fundamentally flawed, for the following reasons:
Data is created from multiple sources (hospitals, clinics, the study participants themselves, and so on). This data is entered into a centralized database management system, which is usually proprietary for each of these organizations. This amalgamation of data is then collated and analyzed by yet another set of specialized agencies that store it and manage it in their own preferred format. This means that the same data might be analyzed and presented to regulatory authorities in different ways and formats, creating confusion. The current data workflow actually hinders collaboration.
Blockchain offers a single, homogeneous, cohesive platform where all stakeholders can share and validate data through smart contracts and a consensus algorithm that ensures that all nodes (stakeholders in this setting) are in agreement before data becomes immutable.
But the potential benefits of blockchain in a clinical trial setting go far beyond data management. Blockchain can also improve efficiency in the subject enrollment process. By storing a patient’s medical record on the blockchain, sponsors can quickly access it and determine the patient’s suitability for an upcoming trial, for example. An additional benefit of this is that the participant can be issued their due compensation via blockchain, without the need for costly third-party institutions such as banks.
Blockchain for supply chain
Logistics, and the entire supply chain, are key elements in global commerce.
How a company produces, manages, transports, and delivers its goods or services will play a key role in determining its profitability, longevity, and popularity. Therefore, the planning, coordination, operation, control and optimization of the many activities, processes, and interactions involved in the whole supply chain environment play a pivotal role for a company, be it a multi-national or small, local firm.
Traditionally, the supply chain has been managed by a group of individuals who pool their resources together within their department. But the advent of blockchain technology is slowly permeating a lot of different industry aspects, including supply chain. Blockchain allows for the decentralization of supply chain management, particularly in terms of data management and scalability.
How can blockchain technology create a superior supply chain
We mentioned the Covid-19 pandemic earlier in this piece. The virus has disrupted the lives of billions of people, and laid waste to businesses worldwide. Supply chain, too, has been severely affected by the turmoil.
Blockchain technology could have offered a two-layered defense here: One, if used to track emerging pandemics as we discussed in this article, Covid-19 might have never occurred in the first place. And the second line of protection would have been in creating a more resilient supply chain to keep produce moving and transport goods (medicines, even vaccines) from point a to point b without preventable delays caused by inadequate paperwork or any other bureaucratic issue. How would blockchain overcome these barriers? Products tracked on-chain carry records of traceability, certifications, tariffs, and any other relevant data that would enable a speedy transit, even in the face of a pandemic, delivering goods on time when most needed.
Blockchain is fast emerging as the go-to piece of technology that enables a transformative leap for many industries, opening up new ways to do business and creating revenue streams.
When applied to clinical trials, blockchain can remove the current inefficiencies found in the flow of data during the trial, streamlining data management and sharing, and ensuring data transparency and immutability.
And if one considers the potential advantages of a blockchain-powered supply chain, the seismic shift towards a more efficient and transparent global commerce really is tectonic.