According to a white paper just published by a blockchain development company, LedgerDomain, preliminary testing of a blockchain-based network, called KitChain, met or exceeded the expectations of the pharma companies and service providers who joined in the effort. The goal was to simulate “tracking shipments of packaged drug product –‘kits’ – being sent to clinical pharmacies at medical centers in the United States.” The participants, led by Pfizer and Biogen, formed the Clinical Supply Blockchain Working Group (CSBWG) to manage the group and coordinate testing. A more sophisticated test, using “real data run in parallel with a live study” is to be run this year, and there is talk of transitioning the CSBWG to a not-for-profit entity for governance and, presumably, an ongoing industry service.
Clinical trials have aspects that are similar to the commercial pharma supply chain—but also have many differences. Chain of custody and chain of identity are crucial, and there is often an elaborate process of bringing together the drug being tested with comparator products and diagnostic equipment. For its part, LedgerDomain developed the iOS app as a layer on HyperLedger Fabric, one of the open-source blockchain infrastructures being developed currently. LedgerDomain brings two proprietary tools, the Selvedge app platform, and the DocuSeal “framework,” which enables “smart contracts and application logic” according to the firm.
The heart of the test was straightforward: sending an advanced shipping notice, and returning a proof of delivery message, using iPhones or iPads to interface with the network. Among other things, the test validated the basic appeal of blockchain technology applied to clinical trials: time-stamped, auditable records of transactions; and the outline of how data gets permissioned among users. Overall, participants in the test rated KitChain at 3.8 on a 1-to-5 scale, with 3.0 being “acceptable.”
Other participants in CSBWG are: AstraZeneca, Merck, GlaxoSmithKline, Thermo Fisher, IQVIA, UCLA, Deloitte, Marken, Bracket, and Almac.