Growing blockchain pilots to prove value in clinical trials

Acceleration of decentralization and digital technologies during the Covid-19 pandemic brought new challenges for secure data handling. While current data processes are prone to duplication and need manual verification, new technologies, such as blockchain, are being tested in the clinical trial industry.

Triall, a blockchain-integrated eClinical platform provider, recently announced a partnership with the Mayo Clinic to advance clinical trial data and study management. Triall’s blockchain solution will be incorporated into a two-year multi-center pulmonary arterial hypertension study, supporting all core trial activities, such as data capture, document and study management, and eConsent.

Quite simply, blockchain is a public and immutable ledger, or database, maintained by many individuals rather than a single entity, explains Hadil Es-Sbai, CEO of Triall. Blockchain can either be private, maintained by a select group of people or organizations from sites, sponsors or CROs, or public, operated outside the clinical study team.

While blockchain has been buzzing around various industries, its use and benefits are not well defined in healthcare, especially in clinical trials. Current literature lacks extensive examples of blockchain integration in clinical trials, says a recently published article. While it has the potential to streamline the data processing process, improve the participant experience and reduce the cost of clinical trials, it must overcome misconceptions and the industry’s lack of knowledge.

Improve trial management and costs

Data is at the heart of every clinical trial, and by anchoring it on a blockchain, it is time-stamped on an immutable ledger. Such a process allows regulators, monitors or scientific journals to verify whether data was present at a particular time and whether it has been changed since then, says Es-Sbai. “It increases resilience against corruption or manipulation of data and can help prevent data dredging, p-hacking and HARKing (hypothesizing after the results are known),” he adds.

A Japanese breast cancer clinical trial incorporated a blockchain-based system to test its ability to protect medical data. The researchers confirmed its resilience to data tampering, but also observed “survival with minimal downtime and secure clinical data capture” during an Amazon Web Services (AWS) cloud server shutdown in 2019.

Usually, the collected data is owned by the sponsor, which raises the question of ownership of patient data. Blockchain opens the door to the use of decentralized identifiers (DID), which means that patients either fully or partially own and control their data, and that it can be used for future research purposes, explains Es-Sbai. This can motivate patients to participate in clinical trials, expand the health data pool for researchers, and can facilitate the screening and recruitment process by finding participants based on their disease profile, he adds.

DID-enabled infrastructure called verifiable credentials (VCs) can also be used to identify and verify the credentials of principal investigators and field personnel. By including medical licenses, training certificates or clinical trial experience in specific health indications, it enables CROs to speed up the onboarding process and delegate responsibility, says Es-Sbai.

Blockchain also has the potential to reduce clinical trial administration costs and visit time. A blockchain pilot was deployed in an active clinical trial (NCT03635099) to compare it with conventional trial management. Researchers found that blockchain reduced the overall average monitoring visit time from 475 to 7 minutes and costs from €722 to €10 per participant/visit. The majority of pilot participants indicated that using the blockchain approach increased their confidence in ensuring their safety and well-being.

Needs education and regulatory guidance

While study participants rated the blockchain technology favorably, study coordinators and clinical research associates (CRAs) had mixed feelings about it, likely due to changes in operational models and parallel execution in the main trial.

The authors of the study identified that the clinical trial industry will need to overcome technological and non-technological barriers to fully integrate blockchain. They also noted that health authorities do not accept blockchain as a tool to support routine clinical trials, and the reported cost savings remain “elusive”. In fact, education and the development of best practices are warranted, as well as guidance from regulators on their stance is needed to accelerate the implementation process, says Es-Sbai.

There is still much to learn about what should be out “on the chain” and what should be left out. “Simply putting everything on a blockchain does not address persistent problems in clinical research, and may introduce more problems than it solves,” explains Es-Sbai. For example, adding data and documents directly to a public blockchain violates privacy regulations, such as GDPR and HIPAA. Sponsors should identify such pitfalls and use this technology only where it adds value, he adds.