We are excited to announce the world’s first clinical trial on the blockchain. A beta version of the foundation’s Verial software application was given green light for use in a real-world clinical trial and is now live in production, following positive assessment of its compliance with international regulations and quality standards for medical research. This marks an important milestone in a journey that we initiated over two years ago. Furthermore, to the best of our knowledge, this represents the first real-world implementation of blockchain in a clinical trial. Below, we’ll briefly introduce Triall, the Verial application, and our plans for a blockchain-enabled future of smarter, safer, and more-efficient medical research.
This post was adapted from this Medium article by Niels Klomp, Director of Technology / CTO for the Triall Foundation.
Triall Foundation: smarter, safer, more-efficient clinical trials
Triall brings together a consortium of clinical trial specialists and blockchain engineers, and was initiated to tackle some of the persisting issues that make clinical trial operations overly complex, lengthy, and resource-inefficient (have a look at this article to learn more about clinical trials).
Most importantly, due to trials involving many different organizations, locations, and data sources, virtually all clinical researchers experience issues with keeping track of their documents and data. Yet, increasingly stringent regulations demand meticulous documentation of all clinical trial conducts, and all documents and their changes should be auditable at any time.
Lacking oversight hampers recordkeeping, resulting in costly reiterations, errors, and even safety risks for patients and consumers.
We believe that applying blockchain technology in the collection and processing of clinical trial data will become the industry’s golden standard. Among other promising use cases (as outlined in the Triall whitepaper), blockchain can provide the many stakeholders involved in a clinical trial with indisputable proof that data has been recorded at a set time under a verifiable condition.
To improve the auditability and operational efficiency of clinical trial operations, Triall together with technology partner Sphereon is developing a series of modular applications on top of the blockchain infrastructure of the Factom Protocol.
Verial: a blockchain-enabled document management solution for clinical researchers
Verial represents the first application in this series. The clinical document management solution enables users to establish verifiable proof of the integrity and authenticity of essential research documents, and to establish an immutable audit trail of their evolution over the course of a clinical trial.
These utilities are powerful, as it generates proof that these documents have not been altered after registration. Hence, it promises to drastically improve the reliability and auditability of clinical research throughout the pharmaceutical development chain, and fully answers to calls for meticulous documentation and data transparency by the U.S. Food & Drug Administration (FDA), European Medicine Agency (EMA), and other regulatory authorities.
Following positive assessment of its compliance with clinical trial regulations and guidelines, we have initiated the use of Verialin a first real-world clinical trial (phase II, <50 participants) as a pilot to optimize usability. This will allow our development team to optimize usability and work towards a first release-candidate version.
The promising use case for blockchain in clinical trials
We strongly believe blockchain can revolutionize the way we approach pharmaceutical research and development, by assuring the integrity and transparency of clinical evidence, and by offering advanced solutions for managing identities and data access. Below, I’ll cover three examples of clinical trial procedures in which our in-development applications promise to add significant value.
- Informed consent
Patients should only be enrolled in a clinical trial after having provided their full, informed consent on the study design and procedures. Proof of informed consent takes the form of an Informed Consent Form (ICF), signed by the patient. Unfortunately, the ICF is regarded as one of the most fabricated documents in clinical research, and researchers are sometimes seen to enroll patients or even start data collection before the ICF is signed.
By registering a hash of the signed ICF on the blockchain, researchers can prove that the patient has consented to participate in the clinical trial in a timely, unfalsifiable, and verifiable way. Moreover, as clinical trial data-capturing tools may also be integrated with the blockchain layer, conditional terms can be set in place, such as only allowing data inputs for a specific patient after that patient’s ICF has been registered on the blockchain. In case there has been a change to the study design (as registered in a trial protocol document), data inputs could be allowed only after patients have consented to the protocol alterations.
- Predefined outcome measures
There have been numerous instances where researchers have changed their initial clinical trial hypothesis and analysis plan after analyzing their research data to beautify their trial outcomes — a process known as p-hacking or data dredging. This is a dangerous malpractice, and regulations therefore explicitly state that outcome measures need to be defined prior to the start of the study. By registering a hash of the Statistical Analysis Plan on the blockchain before the start of the trial, researchers can prove that they have adhered to the predefined outcome measures.
- Database lock
To prevent unintentional and unauthorized changes after final data entry, check-up, and analysis, regulations stipulate that the clinical trial database is locked after data collection has concluded (the ‘database lock’). Strikingly, there have been various cases where researchers did alter their evidence, with health-damaging and costly consequences.
Using blockchain technology, researchers can generate verifiable proof that their data set has not been altered. This can be done in an easy and efficient way, by generating and registering a single hash (32 bytes + optional metadata) of the entire clinical trial database (hundreds of GB).