By Deborah Borfitz

February 10, 2022 | A 36-month PharmaLedger project sponsored by the Innovative Medicines Initiative and the European Federation of Pharmaceutical Industries and Associations is attempting to create a scalable blockchain platform with use cases for clinical trials as well as supply chain and health data. In the trials arena, the focus initially was on eConsent, but the public-private initiative is now intent on creating an end-to-end solution for clinical trial conduct, according to Baldwin Mak, leader of strategic feasibility and management at Boehringer Ingelheim, speaking yesterday at the Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida.

Problems in clinical trials often begin with informed consent because of paper-based processes and manual transcription and verification of data, he says. Any deviation from the consent document can negatively impact patients as well as the study itself.

Across multiple health agencies, over 50% of Good Clinical Practice inspection findings are related to the quality and completeness of clinical trial records, Mak reports. Between 2% and 7% are specifically about informed consent.

Such documents cover trial design, study purpose, risks and benefits of participation, alternative treatments, and individuals’ rights and privacy, Mak says, and define what can and can’t be done. It is important that subjects understand the content—and it be adhered to if they sign. Participants also need to be quickly informed of any changes.  

“We believe blockchain can help us adhere to consent and ensure patient rights and safety,” says Mak. As a distributed ledger, it can be used to capture agreements, transactions, and activities and shared among all members within the blockchain network. No changes can be made without other members being able to see and agree to those changes, he notes.

Blockchain can also serve as “one trusted, immutable source of truth” for conduct related to activities such as screening and the collection and analysis of samples, continues Mak. The information can’t be altered but it can be amended with the agreement of all network members.

Processes related to those activities can be automated once they’re on the blockchain and trigger notifications to re-consent patients if there is an update, he says. Smart contracts can also be used to manage access to sensitive data based on permissions.

A blockchain network for a clinical trial would have many potential ledger-sharing stakeholders—subjects, sites, sponsors, labs, ethics committees, and health authorities—and create transparency, security, trust, and efficiencies, says Mak. It can be a mechanism to “spot check” for errors and contain them.   

When subjects provide consent on the blockchain, that decision is visible to all, he says. And if they later withdraw their consent, that decision is immediately known by network members and triggers a stop to activities, such as analysis of a collected sample, in near-real time.

Combined Use Case

For the eConsent business use case, the goal was a digital solution that leverages the status of informed consent on the blockchain for study visits and data collection and use, Mak says. The idea was to increase awareness of what is happening in a trial and create transparency, data integrity, auditability, and trust.

Cross-industry collaboration on the use case began in the fall of 2020 by defining the required functions and technology, he continues. Work on a minimally viable product began last year and the final version had three user groups—subjects, sites, and sponsors/CROs.

When planning for the pilot began, it quickly became apparent that it had significant crossover with two other use cases for IoT and personalized medicine, Mak says. So, project leaders decided to combine all three use cases to create and test a more holistic clinical trial solution.

That integration work is now underway and is expected to launch this year, he says. The consent status of patients will be used to inform and manage wearable devices with the collection of data recorded on the blockchain. The ability of researchers to request access to data for secondary use, as allowed by patients, will also be tested.

Patients could thereby become “better partners in clinical trials and control what is happening with their data,” he adds. By enabling remote trials, the solution could also make studies more accessible.

This could translate into increased efficiencies and speed for study sites, says Mak. For sponsors, it could mean improved data quality, faster and lower-cost trials, and the ability to access data for the development of other compounds.

For labs, trial management via blockchain can help enforce compliance (e.g., halt assessment of a sample collected in error or respond to a patient’s withdrawal from a trial) and enable tracking and tracing of samples, he says. Ethics committees and regulatory authorities can likewise ensure compliance and reduce protocol deviations, as well as triage inspection of sites and do so remotely.

Barriers to adoption of blockchain technology need to be further explored, say Mak, including technological issues related to interoperability, scalability, security, and privacy. Ideally, study sponsors will one day be able to tie into the shared ledger via plug and play devices.

The PharmaLedger project has nearly 30 collaborators, including 12 global pharmaceutical companies and 17 public and private entities. The list includes Boehringer Ingelheim as well as Novartis, Novo Nordisk, MSD, the Polytechnic University of Madrid, and the Romanian software company RomSoft.