TrialSite News recently interviewed Daniel R. Wong of Bakar Computational Health Sciences Facility, University of California San Francisco. Mr. Wong, along with Sanchita Bhattacharya and Prof. Atul J. Butte recently envisioned and designed a comprehensive blockchain-based clinical trial management system. With their results published recently in Nature, they embarked on an innovative software development journey as they recognized that the monitoring and ensuring of integrity of data within the clinical trial process is not always feasible with the current research system. They envisioned and developed a solid prototype of a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially trustworthy.
As the UCSF designed the software, they utilized raw data from a legitimate, completed clinical trial; simulated the trial onto a proof of concept web portal service; and tested its resilience to data tampering. Moreover, they assessed its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. Their results reveal an improvement in the way adverse events were reported. In their study, they concluded that their software platform could offer an improvement in clinical trial data management, and could bolster trust, data validity and quality, and performance in the clinical research process, as well as the ease at which regulators can potentially oversee trials.
TrialSite News briefly caught up with Daniel Wong. He reported that in the blockchain-based system, they have envisioned a comprehensive service layer where the following clinical trial management capabilities could be managed:
- Electronic Data Capture
- Clinical Trial Management System
- Adverse Event System
- Integrated Response Technology
In this way, their clinical trial management system can also become a next generation, secure, blockchain service bus that can interoperate legacy underlying systems, such as electronic health records, legacy trial master files, and trial management systems. The UCSF team is planning to build out and scale the system. First, they are in the process of hiring a team to build out a commercially ready version—it is currently in a solid beta, early adopter mode. Second, they will utilize the system within the UCSF system. A nationally prominent academic medical center conducting hundreds of trials—from investigator initiated, to government-sponsored, to industry sponsored initiatives—the UCSF team has a powerful platform to test and harden the system.
Mr. Wong is confident, based on the prototype results, which reflect a compelling framework that could scale and ultimately contribute tremendous value. He noted that the clinical trials management space still, even in 2019, is struggling with a dependence on paper, compliance challenges, and software performance issues. The UCSF team is banking that a blockchain-based solution could be the path forward.
We were thoroughly impressed with Mr. Wong’s confidence, conviction, and vision to build and scale this UCSF-developed, blockchain-based, clinical trial management system. He exhibited an enthusiasm and openness that we found refreshing.
TrialSite News does have questions about blockchain technology. We believe there is a certain amount of hype associated with this technology. In some cases there may be compelling use—in others there could be a solution in search of a problem.
Some fundamental issues represent intriguing questions to consider. To start, we believe that if any organization is to consider developing a blockchain-based system, they could examine how the blockchain solves the core business use cases in a way that couldn’t be solved by more traditional, but well-known methods, such as digital signatures, best privacy and data protection practices, etc. Moreover, we asked Mr. Wong if there was any key benefit derived from blockchain’s distributed ledger paradigm. Interestingly, UCSF believes that the ability to secure, maintain and ensure validity of records could represent a fundamental benefit. However, blockchain use cases become intriguing with an absence of a central authority. In the case of the world of clinical trials, the FDA is an ultimate central authority—at least in the United States. Moreover, cryptocurrencies that rely on blockchain are known to have poor transaction confirmation times, which could generate some friction in use cases where transaction confirmation expediency is critical. Mr. Wong and the UCSF team don’t think this represents any obstacle for scale out with the system.
Other critical items to acknowledge include the critique that blockchain represents a computationally inefficient method of achieving the same thing as traditional cryptography (and digital signatures) in many use cases where it is now being applied. An MIT Technology Review article discusses the challenge of energy consumption of current widely used blockchain protocols. We were not able to address the potential future energy consumption challenges with the UCSF team. Perhaps their vision dovetails with those that foresee solutions.
As the UCSF team expands and proceeds with developing a commercially validated product, they have considerable potential to explore value-added market-based scenarios. Assuming they can build out a fully validated product that offers clear and compelling value internally, it could expand rapidly within UCSF—one of the most prominent research institutions in the United States. That reality could open up commercialization options which would afford Mr. Wong and the team intriguing choices.