Last week, Triall presented at the Utrecht Blockchain Nights to discuss the relevance of blockchain-based mechanisms for clinical trials and international cooperation during infectious disease outbreaks. The night was hosted by Lisk Center Utrecht, a professional blockchain hub that aims to make blockchain tangible with real-life use cases to inspire corporates and innovators.
Utrecht Blockchain Nights
The Utrecht Blockchain Nights webinar consisted of 3 educational talks on the impact potential of blockchain technology for the Life Sciences & Health domains. Joost Flach (Head of Clinical Affairs at Triall) gave an overview of specific challenges in the clinical trial industry, outlining how blockchain technology can be applied to address these challenges and promote data integrity, auditability, and operational efficiency. Mark van der Waal (Head of Product Design at Triall) discussed the relevance of blockchain-based mechanisms in the context of shared innovation in the Life Sciences, taking the example of international research cooperation during infectious disease outbreaks. Lastly, Abe Scholte (Technical Consultant at Sphereon) zoomed in on the concepts of tokenization and tokenized ecosystems, reflecting on the current state of these topics in healthcare.
Blockchain-mechanisms for clinical trials
The clinical trial industry is responsible for the introduction of novel medical solutions to society, by testing these solutions for their safety and efficacy in human subjects. Over the past decade, clinical trials have become increasingly complex, regulated, compartmentalized, and data-heavy. While large pharmaceutical developers (‘big pharma’) are able to purchase all-encompassing IT systems that handle these difficulties, small-to-medium-sized organizations (making up over 70% of the industry) typically cannot. As a result, the majority of the industry experiences a lack of oversight over their clinical trial operations and activities. This translates into recordkeeping delays, costly reiterations, and many other resource-inefficiencies, ultimately delaying the time-to-market of novel medical solutions while also driving up their price.
Blockchain technology introduces unique capabilities for improving the reliability and efficiency of clinical trial operations, and may therefore contribute to accelerated and more-efficient development timelines. Using blockchain-registered immutable audit trails, verifiable proof can be established of the existence and authenticity of trial documents and other data objects over the full course of the clinical development timeline (typically spanning over 10 years). This mechanism can be used to promote the data integrity, traceability and auditability of increasingly complex and data-heavy trial operations. Moreover, a decentralized public key infrastructure with Decentralized Identifiers (DIDs) for identity and access management (IAM) can enable the safe and compliant transfer of data between organizations and software systems, thereby promoting interoperability and addressing the issue of data compartmentalization. As a final example, Joost touched upon the potential of smart contracts for workflow automation and stage-gated process evaluation. Smart contracts can be used to promote regulatory compliance and operational efficiency by asserting and automating rules for workflows, data access, and transactions.
Blockchain-mechanisms for international cooperation during infectious disease outbreaks
There are several persistent barriers that obstruct data sharing and cooperation between researchers in the context of epidemic emergencies. These barriers are rooted in a lack of trust among stakeholders, complex regulatory procedures, conflicting public and private incentives, and uncertain ownership rights. Mark discussed how a system that anchors into blockchain technology can support an ecosystem of R&D stakeholders by providing a common, inviolable, and verifiable layer of records for identities (e.g. for resources, individuals, and organizations), rules (e.g. terms and conditions for data access and benefit-sharing), and events (e.g. access events and transactions in the context of benefit-sharing). He explained how a combination of emerging standards (such as DIDs and Verifiable Credentials), blockchain proofs, and on-chain permissioning schemes enable such a system to facilitate and coordinate the sharing of sensitive and valuable resources across existing storage systems. The conceptualized system, which was recently published in Science Magazine, is the result of several years of collaboration between Life Sciences innovation researchers, and experts in infectious disease control at Vrije Universiteit Amsterdam, FutureLab, and the Center for Infectious Disease Control of RIVM (Netherlands National Institute for Public Health and the Environment).
The Science publication can be found here.