March 18, 2019 | Clinical research is a complex process involving various actors where trust, data sharing, security, and visibility need to be established from clinical trial participants, physicians, researchers, service providers, sponsors, and regulators. This is where blockchain comes in, says Disa Lee Choun, Director Head of Innovation, Global Clinical Sciences & Operations at UCB.

Lee Choun has over 15 years of experience in the pharma industry, focusing on clinical trial innovation from blockchain, sensors, devices, AI, and robotics. She now co-leads the blockchain work group within PhUSE, a non-profit organization acting as a global platform for the discussion of topics encompassing the work of data managers, biostatisticians, clinical data scientists, and eClinical IT professionals.

On behalf of Clinical Research News, Lee Yuan spoke with Lee Choun about the challenges of adopting blockchain in clinical research, as well as use-cases of it being effective.

Editor’s note: Yuan, a Conference Producer at Cambridge Healthtech Institute, is planning a track dedicated to Blockchain in Pharma, R&D, and Healthcare at the upcoming Bio-IT World Conference & Expo in Boston, April 16-18. Lee Choun will be delivering a co-presentation with Adama Ibrahim on the program. Their conversation has been edited for length and clarity.

Clinical Research News: What do you feel are the biggest challenges in blockchain adoption in industry and why?

Lee Choun: There are many different challenges. In my view, one is the maturity of the technology, also the scalability, the data ownership, the complex technology ecosystem, and governance. The complexity around governance, [includes] the lack of regulations, the standardization, and change management, just to think of a few.

All these challenges make it more difficult to scale up. Scaling up solutions is tough due to both complex internal processes and external governance and adoption.

One challenge is trying to identify the right use-case where we can apply this DLT (Distributed Ledger Technology), blockchain. I think not everything fits like a glove, so we need to do a lot of investigation and exploration to see what fits, to see what will work and what will not In few years’ time, we might see the technology mature. We also might see more advances not just the platforms and protocols, but also in developers being able to come with some of the solutions that we currently don't have such as storing bigger data size, designing green technology with bigger processing power, etc.

I think data ownership is one of the key questions we need to answer and define when it comes to this technology. Right now, as an example, we aren't even able to resolve the question of who owns medical health records. As a patient, I don't even know if I own my records. We all assume we do, but these are owned by the organizations that hold your data, and of course, accessing and the idea of aggregating all your health data is challenging and complex especially if a person moves to a different region, let alone to a different country. If looking at the whole ecosystem of blockchain, and all the different stakeholders that play into this, it is not just one company’s job, but it requires a collective effort.   effort; This is why we formed the PhUSE Blockchain Workgroup with other companies and recently we started the IMI (Innovation Medicines Initiative) Blockchain Enabled Healthcare consortium where we have private and public partners, to help in trying to resolve some of the  challenges that we see today.

Speaking of use-cases and finding the right use-case, where do you see blockchain technology being the most effective for clinic trial professionals? And why?

Yes, so there are many use-cases being discussed and shared. UCB is part of the IMI Blockchain project, a €18 million project funded by  EU and nine pharma companies.  It includes 13 participating companies from universities, hospitals, and technology companies . We are looking into  four main areas or categories: supply chain,clinical trials, health data, and others (procurement).  In supply chain, the focus is on  drug provenance, starting from the shipment of ingredients sent to manufacturing and then the drugs shipped all across the different points to distributors, and to the pharmacies where we would have the full traceability of the journey of the product to avoid issues like counterfeiting, etc.

In terms of clinical trials, the focus is about  accelerating the drug development process, starting from identifying and recruiting the right patients on day one.

According to literature, 87% of patientsare motivated to share their health data for research (PhUSE How Blockchain Can Transofrm The Pharmaceutical And Healthcare Industries, 2018  https://www.phuse.eu/documents/working-groups/deliverables/phuse-blockchain-white-paper-final-version-1-18843.pdf ). If we take that number of patients, and they're waiting to share the data through blockchain, having that ability to share and having that privacy element embedded as well, as part of blockchain, we're able to already assess whether the patients will qualify or not for the clinical trial. Looking at the inclusion/exclusion criteria, we can readily already establish that, and have the patients involved in clinical trials from day one. That's the scale of the process, because what we've seen in general [is that] the recruitment time takes 1/3 of the clinical trial timelines. If we reduce that element, imagine the time the drugs will be out there in the market for patients in need. That's one of the specific use-case that we've been looking into.

The other one, in terms of data provenance, we're looking at is  the data quality. This would improve drastically as the process would be more automated with how the data move from one place to another in a standard way. The idea is that all the different stakeholders that are involved in delivering a service in the clinical trials, would have access to that information where exchange can take place, where we're able to see real time information securely. Eventually, at the end of the clinical trial we can pass back the data to the patient we collected, for example any vital signs, or any tests that they’ve done, basically hand back the data to the patients and have this form part of their electronic health records. This would be an  ideal situation. and something we want to explore.

From the regulator point of view, for example FDA or EMA, if they are granted access to the clinical trial blockchain, they can see the real time information and be able to do ongoing reviews and assessments. Because at the moment the reviews are done at the end of clinical trial or during submission for new drug approval. If the regulatory bodies become part of the blockchain network, imagine the level of transparency that they would have.  This would change the whole process not only for  pharma, researchers but also the regulatorybodies. I think there's a lot of benefits with blockchain, we need to identify the right use cases and leverage the expertise of different companies via different workgroups and consortiums like PhUSE Blockchain workgroup and the IMI Blockchain Enabled Healthcare.  Cross-industry collaboration is key for early adoption of a new technology like blockchain.