Boehringer Ingelheim (Canada) Ltd. (BI) and IBM Canada are partnering to make clinical trials safer and more efficient through the use of blockchain.

In a Canadian first, blockchain technology will be used in parallel with traditional techniques to log and track patients’ journeys throughout a pilot project beginning this month.

“The blockchain system will log what the patient’s consent directive is, and then track the patient’s progress through the trial,” Bryan Addeman, blockchain market leader at IBM Canada explained in an email. “The idea is that when the patient comes in for a trial visit, the clinical site will have a portal where they can view which procedures the patient has consented to, and more importantly, which they have not consented to for that specific visit.  The hope is that risks to violating the patient’s consent can be identified and resolved before they happen, improving patient safety.”

The system will provide a single source of truth that is always up-to-date, and grants each stakeholder (patients, clinical sites, pharmaceutical sponsors, regulatory inspectors, and others) access to only the information they are allowed to see, protecting patient privacy.

Dr. Uli Brödl, vice-president, medical and regulatory affairs, Boehringer Ingelheim (Canada) Ltd.

Dr. Uli Brödl, vice president, medical and regulatory affairs, Boehringer Ingelheim (Canada) Ltd., said that BI started thinking about the value proposition of blockchain for healthcare in 2017, and approached IBM in mid-2018. It is already using the technology in supply chain management and is looking at other business applications such as data sharing and payment systems.

“Since we are in the clinical trial business, we realized that the ecosystem is very complex, with many stakeholders, resulting in limited trust, transparency, little patient empowerment, high inefficiency, process inefficiency, that may impact trial quality and increases cost,” he said. “With this in mind, since we believe in partnering for success, we approached IBM with the project to ultimately improve patient care and serve patients in the healthcare system.”

He went on, “Our understanding and hypothesis is that blockchain technology in healthcare improves trust, transparency, patient empowerment, and in clinical trials, via process automation reduces human error, therefore increasing trial quality and patient safety at reduced cost.”

Addeman said that, while this is the first application in clinical trials, he has seen increasing activity around blockchain in healthcare in the past year, much of it involving patient consent for access to their health records. Identity management and claims verification are two other hot topics. He said that while many blockchain use cases require a certain level of adoption before we see benefits, the BI project is exciting because it has the potential to immediately improve patient safety.

It also has the potential to be used in multiple types of trial, according to Brödl. “The concept should be applicable to any disease area and should be applicable to prevention trials as well as treatment trials,” he noted. “The technology and the value proposition of the technology are pretty much disease agnostic.”

Results on the pilot projects are expected in the second half of this year.

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