Blockchain technology first came on the scene in 2017. Since then it has generated high expectations: blockchain applications in clinical trials have always had the potential to automate outdated ways of working and rapidly piece together disparate data sets, in a secure and auditable manner. Somehow, it seems as if blockchain failed to live up to its potential as the pharma industry struggled to implement it within the sector.
And then, COVID-19 hit, and the pandemic may just be the ultimate push blockchain needs to accelerate its implementation as a solution to some of the long-standing issues facing clinical trials and associated supply chains in healthcare.
Data stored within blockchain is auditable, trackable, immutable and can be used to create a longitudinal record of a patient’s health status, as well as participation in clinical trials. With the advantages it brings in terms of security, and the validating nature of the technology, blockchain application in clinical trials can unlock actionable insights to help navigate through this crisis. For a more detailed look of how blockchain works, please take a read of my original article here.
COVID-19 spurs on virtual trials
The effect of the pandemic was alarmingly immediate on clinical trials. Many trials experienced delays or were put on pause as hospitals that serve as trial sites were overwhelmed with COVID-19 patients and were no longer available. The number of disrupted clinical trials has continued to grow over the last three months, with suspension of enrolment accounting for 61.5% of the disruptions.
This has led to an increasing push towards virtual trials or at least elements of virtual trials that are now more likely to come to the forefront faster than they otherwise would have done due to the pandemic. In its most extreme form, a virtual trial has the potential to completely separate patients from direct contact with a trial site or provider, and where patient recruitment, consent and data collection are all conducted virtually. This could immediately help trials that are being met with patient quarantine and travel limitations, clinical site closures and interrupted supply chains.
How can blockchain technology help virtual trials?
Up to this point, many obstacles have hindered the popularity of virtual clinical trials: lack of data integration and unclear regulatory acceptance being the major ones stopping pharma companies and CROs from incorporating virtual components into their trials. This is where the implementation of blockchain arguably has its strongest use case. It has the potential to aggregate data coming from clinical sites, investigators and patients in a secure, transparent and auditable manner that allow for effective analysis and alleviates pressures to follow procedures, document things correctly and any medical dispensing errors. Furthermore, in the midst of a global pandemic, pharma regulators (who have arguably been slow to accept technology adoption in the past) are now more than ever likely to acknowledge the need for change and acceptance of digital endpoints in clinical trials. The Dutch government is a great example of senior political leadership now working to deploy a blockchain-based solution to ensure transparency across the medical supply chain in the fight against COVID-19 – read about their ‘Tech against Corona” initiative here.
Specific, working cases include Pfizer and Biogen’s joint design of KitChain: an iOS-based application designed to fit into the clinical trial supply chain workflow. It provides an immutable digital record for inventory and event tracking, and also enables users to securely send messages between shippers, recipients and third parties. Over the longer-term, the group envisions a blockchain platform that supports the performance requirements of the clinical supply chain, streamlines collaboration and cements a single version of the truth.
Who is using blockchain applications in clinical trials?
So, what companies are bringing blockchain to clinical trials?
- IBM and Boehringer Ingelheim entered a collaboration in 2019 to test the capabilities of blockchain technology in clinical trials management (specifically, patient recruitment and retention).
- Technology specialist Alten Calsoft Labs also launched its blockchain initiative, BioPharma Ledger, with Clinlogix as its first customer – one of the first CROs to officially pilot and implement a blockchain platform in real world clinical trials.
- Sphereon, through its work within the Triall Foundation, is also perhaps a blockchain specialist to keep a close eye on – last summer, the Triall Foundation initiated the use of its blockchain application Verial in a first real-world clinical trial (phase II, <50 participants) as a pilot to optimise usability. The clinical document management solution enables users to establish verifiable proof of the integrity and authenticity of essential research documents, and to establish an immutable audit trail of their evolution over the course of a clinical trial. This has the potential to fully answer calls for precise documentation and data transparency from the FDA, EMA and other regulatory bodies.
Despite these first initiatives for blockchain, many big industry players are still holding back. The major problem is the lack or perceived lack of a regulatory pathway for the approval of products where blockchain has been used in the virtual trail. Through a COVID-19 lens, this perspective will change considerably, as pharma companies and regulators are forced to accelerate technological changes and look towards enhancing and digitalising the clinical supply chain in the increasing prevalence of current or future pandemics.
M&A activity in blockchain solutions for clinical trials
Does this mean M&A activity in blockchain solutions for clinical trials is imminent? The short answer is blockchain has yet to pass the hurdles in its implementation within clinical trials (the most obvious being clear regulatory acceptance) before it starts to attract strong investment in this space. However a surge in recent investment within leading virtual clinical trial companies is inevitable as the pandemic has produced a steady stream of sponsors looking to change their protocols to rescue ongoing trials. Only in May, Medable raised $25m in funding to expand its global platform for decentralized clinical trials led by GSR Ventures, with additional investment from existing investor PPD.
Other key virtual trial companies to keep a close eye on include VirTrial, Science 37 and Clincal Ink: all experiencing a surge in business in both March and April. It will be interesting to watch how and if these companies accelerate their employment of blockchain solutions in the near-term; The good news is that the COVID-19 spotlight may be the much needed push comes to shove for regulatory bodies and the pharma industry to work with virtual trial companies and finally put the implementation of blockchain into practice.