An iPhone App is the “frontend”–and a blockchain server platform is the “backend”–of a solution now available for the logistical challenges of increasing numbers of complex clinical trials of investigational pharmaceutical products. Participants are members of a nonprofit consortium evolved out of the “Clinical Supply Chain Blockchain Workgroup” (CSBWG) that The Pfizer Blockchain Center of Excellence initiated in November 2017, and with representatives from drug companies and others involved in the clinical trial supply chain. Here’s our take about KitChain – and how it’s transforming the logistics of clinical-trial supply chains.
After months of analyzing problems of drug manufacturers, medical center testing sites, principal investigators, as well as shipping agents in coping with much greater demand for clinical trials—often under time pressure—the consortium produced a white paper detailing a blockchain solution. It also created and extensively tested a new iPhone App, KitChain. It’s an app that members of the consortium use to access the blockchain. They use it to “track and trace” the supply of the required investigational new products from the manufacturer to “acknowledge consumption” by the patient.
The Challenges for Clinical Trial Logistics
The white paper explained that medical centers involved in running clinical trials had been encouraged to manage their supply chains. However, the demand for trials was overwhelming their efforts. This resulted in rejected requests for taking on trials or long delays. The need for timely, effective trials made headlines with the testing of the vaccines for coronavirus. However, thousands of other experimental new drugs required the same testing—often with a sense of urgency.
The white paper put it this way:
“Both clinical studies and their attendant supplies are exploding in number, complexity, and scope, with increasingly specialized storage conditions and shorter windows of expiration. Clinical sites are struggling to meet these demands, which have slowed enrollment and sometimes forced them to turn away new studies. With personalized medicine on the horizon, these trends are likely to become even more challenging.”
The consortium for use of the blockchain, and the App to access the platform, are now active. The United States views it as a B2B consortium open to healthcare enterprises, drug manufacturers, as well as logistics providers.
Tackling the logistics issues of clinical trials presented the working group with complex, sensitive issues:
- The end-users of the experimental drugs, patients voluntarily enrolled in a trial, have to receive their drug doses on an exact timetable. Otherwise, the validity of the trial (dosages, their timing, assured patient compliance) is at risk.
- Most trials are double-blinded. Clinicians administering the new drug, and patients themselves, do not have access to know which patient receives the drug and which patient a placebo.
- Medical center administrators have many trials to manage simultaneously. Verification of shipping and delivery of the experimental drugs must be flawless. (Based on its surveys, the CSBWG expected an average of 21 users at each member organization, with each such group sending an average of 7,800 messages each month.)
- Data gained from tracking patients through a clinical trial is confidential to the investigators; in some cases, it requires deletion—destroyed—when it has served its purpose.
Key Elements of the Blockchain Solution
The consortium’s task, as reported in the white paper, was to match the capabilities of blockchain—interoperable, transparent, and auditable platforms accessible as needed and permitted—with the challenges of clinical trial logistics:
- The blockchain can provide advanced shipping notification to medical centers, principal investigations, and participating clinicians; tracking of all shipments; and proof-of-delivery.
- Smart contracts can encrypt agreements that ensure a given block, with its data, is accessible only to those with permission and so protect data, which becomes immutable when that block is closed, providing an auditable and interoperable—but also immutable—digital record of the data.
- The problem of data that must later be deleted from all records is solved by creating databases linked with but not part of the blockchain ledger.
Other, but closely related, issues were disparate parties involved in the chain of custody; the “comparator” products that medical centers purchase from other vendors; regulatory reporting; limits to onsite (medical center) storage capacity; incorporation of internet technology (IoT) devices; and facilitation of payments.
The Hyperledger Fabric Protocol
The protocol layer chosen by the working group is Hyperledger Fabric. It is a platform that is an open-source framework hosted by The Linux Foundation. Fabric networks are permissioned. This means the authentication of all participating members’ identities. It’s a feature that the Working Group deemed as essential and explained in the white paper. Namely, the data privacy, as well as security demanded by healthcare, require a shared-permission blockchain-based system.
Access by KitChain
The working group viewed, as the heart of their effort, KitChain, the mobile application giving all consortium members easy access to the supply chain workflow. (The name of the App reflects the shipping of most experimental new drugs in the form of kits.) It employs XML-based messages securely between shippers, recipients, as well as interested third parties. In the final pilot test of KitChain, the Working Group members took different “roles” within the supply chain, such as shipper or recipient. They independently evaluated the performance. The white paper also reports that KitChain scored a rating of 3.8 out of 5.0. The Working Group views this as comfortably surpassing the requirements set for it.
The sponsorship today of KitChain is by the Blockchain for Clinical Supply Chain-Industry Working Group. Members at this time are Pfizer, Biogen, AstraZeneca, Merck, GlaxoSmithKline, Thermo Fisher, IQVIA, UCLA, Deloitte, Marken, Bracket, and Almac.
Bringing up-to-date the problems that the CDBWG sketched in the white paper, KitChain reports that over the last decade the number of active clinical studies has almost doubled. It reported that “clinical pharmacies are bursting at the seams.”
Without attention to the logistics challenge that this presents for clinical study sites, KitChain predicts, needed drug trials could remain “in limbo” for months or years.
Largest Pharmaceutical Blockchain Consortium
The CSBWG has become the world’s largest pharmaceutical blockchain consortium, with members reporting combined annual revenue of $250 billion. Sponsors now also include chief marketing officers, contract research organizations, academic medical centers, and one courier. “These leaders all envision a collaborative blockchain solution as a paradigm shift to deliver a win for patients awaiting new medicines.”
The KitChain site succinctly summarizes its strengths for visitors seeking the app and thus access to the blockchain platform:
- Tracking products and supply shipments anywhere in the supply chain in a system integrated with that of partners in the supply chain.
- Security of the supply chain ensured by blockchain technology.
- Reduced paperwork and manual records across the entire supply chain.
- Collaboration among pharmaceutical companies working together in a shared clinical supply chain.
Potential of the Blockchain Solution
The National Center for Biotechnology Information reported some 10,974 ongoing trials enrolling 2.8 million subjects. The potential scope of the KitChain system seems unlimited. Some 60 percent of those trials are testing drugs—KitChain’s focus. But there also are behavioral trials (10 percent of the total) and tests of biologics (10 percent). The latter two fields appear to offer scope for the blockchain solution even if, and when, all pharmaceutical companies have adopted it.
ClinicalTrials.gov reports that as of March 2022, slightly more than half of “clinical studies” (not all are investigations of new drug or technology trials) are outside the United States. It should not be long before the “collaborative blockchain solution…paradigm” becomes a U.S. export.