The iPhone app is the “front end” Blockchain The server platform is the “back end” of a solution that addresses the logistical challenges of increasing the number of complex clinical trials of investigational new drugs. Participants are members of a non-profit consortium that evolved from the “Clinical Supply Chain Blockchain Workgroup” (CSBWG). Pfizer Blockchain Center of Excellence Launched in November 2017, it was launched with pharmaceutical companies and other representatives involved in the clinical trial supply chain. Our view of KitChain is how this is transforming the logistics of the clinical trial supply chain.
The consortium details blockchain solutions after months of analysis of shipping agency issues to address the much larger demands of pharmaceutical companies, medical center test sites, principal investigators, and clinical trials. I have created a white paper to do.Also Created a new iPhone app and extensively tested it, KitChain. This is the app that members of the consortium use to access the blockchain. They use it to “track and track” the supply of the required investigational drug from the manufacturer in order to “acknowledge consumption” by the patient.
Clinical Trial Logistics Challenges
The white paper explained that the medical centers involved in conducting clinical trials were encouraged to manage the supply chain. However, the demand for testing overwhelmed their efforts. As a result, the trial request was rejected or there was a long delay. The need for timely and effective testing Coronavirus vaccine test.. But thousands of other experimental new drugs required the same test — often with a sense of urgency.
The White paper Say this:
“Both clinical trials and their associated supplies are exploding in number, complexity, and scope with increasingly specialized storage conditions and shorter expiration dates. These trends can be even more difficult as personalized medicine is imminent, which is struggling to meet, which delays enrollment and sometimes forces new studies to be rejected. I have.”
A consortium for using the blockchain and an app for accessing the platform have been activated. The United States sees this as a B2B consortium open to healthcare companies, pharmaceutical companies, and logistics providers.
By addressing the logistics issues of clinical trials, the working group had complex and delicate issues.
- Patients who are end users of experimental drugs and who are voluntarily enrolled in the study should receive the drug dose on an accurate schedule. Otherwise, the effectiveness of the study (dose, timing, reliable patient compliance) is at risk.
- Most trials are double-blind. Clinicians and patients themselves who are taking new medicines do not know which patients receive the medicine and which are placebos.
- Medical center managers have many exams to manage at the same time. Verification of experimental drug shipment and delivery must be perfect. (Based on the survey, the CSBWG predicts an average of 21 users in each member organization, and each such group sends an average of 7,800 messages each month.)
- The data obtained by tracking patients through clinical trials is confidential researcher information. In some cases, it may need to be deleted (destroyed) when it serves its purpose.
Key elements of blockchain solution
As reported in the white paper, the consortium’s task is to address the capabilities of the blockchain, an interoperable, transparent, auditable platform that is accessible when permitted, as a clinical trial logistics challenge. Was to match.
- Blockchain can provide advance shipping notices to medical centers, key research, and participating clinicians. Track all shipments. And proof of delivery.
- Smart contracts protect your data because you can encrypt contracts that make certain blocks and their data accessible only to authorized persons. The data becomes immutable when the block is closed, providing auditable and interoperable, as well as immutable digital recording. data.
- The data issue that needs to be deleted from all records later is solved by creating a database that is linked to the blockchain but not part of the blockchain. ledger..
Another but closely related issue was the different parties involved in CoC. “Comparator” products purchased by medical centers from other vendors. Regulatory reporting; Onsite (medical center) storage capacity limits. Embedded Internet of Things (IoT) devices. And promotion of payment.
Hyperledger fabric protocol
The protocol layer selected by the working group is Hyperledger fabric. This is a platform that is an open source framework hosted by TheLinux Foundation.Fabric network approved.. This means authenticating the identities of all participating members. This is a feature described in the white paper that the working group considers essential. In short, data privacy and the security required by medical institutions require a blockchain-based system with sharing permissions.
Access by KitChain
At the heart of their efforts, the working group considered KitChain, a mobile application that provides easy access to supply chain workflows for all consortium members. (The name of the app reflects the shipment of most experimental new drugs in the form of kits.) It’s an XML-based message securely between shippers, recipients, and interested third parties. Is adopted. In KitChain’s final pilot test, members of the working group played various “roles” in the supply chain, including shippers and recipients. They evaluated their performance on their own. The white paper also reports that KitChain received a rating of 3.8 out of 5.0. The Working Group believes this comfortably exceeds the set requirements.
KitChain is sponsored today by the Blockchain for Clinical Supply Chain-Industry Working Group. Current members are Pfizer, Biogen, AstraZeneca, Merck, GlaxoSmithKline, Thermo Fisher, IQVIA, UCLA, Deloitte, Marken, Bracket and Almac.
latest Problems sketched by the CDBWG In a white paper, KitChain reports that the number of active clinical studies has nearly doubled in the last decade. It reported that “clinical pharmacies are rupturing at the seams.”
KitChain predicts that if we don’t pay attention to the logistics challenges this poses to clinical research sites, the required clinical trials can remain “deadlocked” for months or years.
Largest Pharmaceutical Blockchain Consortium
CSBWG has become the world’s largest pharmaceutical blockchain consortium, with members reporting a total annual revenue of $ 250 billion. Currently, sponsors also include Chief Marketing Officer, Contract Research Institute, Academic Medical Center, and one courier. “All of these leaders envision a collaboration blockchain solution as a paradigm shift to bring victory to patients waiting for new drugs.”
The KitChain site briefly summarizes its strengths for visitors looking for an app, that is, access to the blockchain platform.
- An integrated system with supply chain partners to track product and supply shipments anywhere in the supply chain.
- Supply chain security guaranteed by blockchain technology.
- Reduce paperwork and manual recording across the supply chain.
- Collaboration between pharmaceutical companies working together in a shared clinical supply chain.
Potential of blockchain solution
The National Biotechnology Information Center We reported approximately 10,974 ongoing trials enrolling 2.8 million subjects. The potential range of the KitChain system seems to be unlimited. Approximately 60% of these trials are drug tests that KitChain focuses on. However, there are also behavioral tests (10 percent of the total) and biopharmacy tests (10 percent). The latter two areas appear to provide a range of blockchain solutions, whether or not all pharmaceutical companies have adopted blockchain solutions.
ClinicalTrials.gov Report As of March 2022, more than half of the “clinical trials” (not all new drug or technical trial studies) are outside the United States. It won’t be long before the “collaborative blockchain solution … paradigm” becomes an export to the United States.