Clinical Research And The Impact Of Blockchain

February 15, 2019 | New technologies are developing that attempt to enhance the collaborative process between professionals across a plethora of industries. Blockchain is one technology that ignites this collaborative spirit, according to Adama Ibrahim, an associate director of clinical operations at Biogen.

With almost 18 years of experience in research spanning different phases of studies, therapeutic areas, as well as different regions and locations, Adama understands how the consolidation of information can influence and enhance the way companies approach problems and develop solutions.

On behalf of Clinical Research News, Lee Yuan spoke with Adama about the challenges in blockchain adoption, and where blockchain technologies can be the most effective for clinical trial professionals.

Editor’s note: Lee Yuan, a Conference Producer at Cambridge Healthtech Institute, is planning a track dedicated to Clinical Supply Management at the upcoming Summit for Clinical Ops Executives, SCOPE, in Orlando, February 18-21. Adama will be speaking on the program, discussing how the cross-industry collaborative evaluation of blockchain can transform the pharmaceutical and healthcare industry. Their conversation has been edited for length and clarity.

What do you feel are the biggest challenges in blockchain adoption in the industry and why?

The biggest challenge is the fear of the unknown. I think that is the number one challenge and it's huge because it's the personal fear that everyone has with something different and something new. Trying to address that means that we have to strip that fear to its core and understand what is it that makes people uncomfortable with change and new technology specifically. In our industry we are very regulatory driven, we are very compliance driven, we need to be inspection ready, and we need to make sure we are really protecting patient safety and also ensuring we are optimizing our resources the right way. So from that point of view, if you look at these challenges then it is a case of identifying tradeoffs. For example,  our legacy systems and enterprise database systems are working very well. And so it is very hard for us to really understand and see the vision that there is actually a new paradigm that can be introduced that can actually support and help us to move things a lot quicker, better, transparently, and address existing challenges. So I think the first and biggest challenge for me is definitely the human element.

The second challenge is the newness. This is also linked to the first but it's different in the sense that the emerging technology curve is slow. So that means that if you're not an early adopter as such, you are kind of going to be lagging behind in trying to even understand what it is from an educational point of view. So the fact that it is new means it's not out there, it's not widely used, people don't have that experience of touch and feel and learning and understanding of how to apply it. Once that lack of commonness or lack of availability or adoption levels has been addressed, I think the challenges will break down significantly.

And then I think the final thing is something that I think people should also address quite openly. It's not anything to do with technology breaking down or any of the other situations we have seen with similar new technologies, but it is actually the way that the value can be unleashed using this type of technology. It means that we get closer to patients, we get closer to owners of data. And that makes it quite uncomfortable again for people because it's something we don't typically do. As sponsors we have to be well away from the end user, so we have to have these third parties, we have to have data controllers, we have to have so many layers of road blocks between us. Blockchain strips that all away, and it means that there is enough protection inherently within the technology to enable us to communicate directly in a two-way fashion. So I think those three things are the immediate challenges.

As more people start adopting blockchain in their practices, where do you see blockchain technologies being the most effective for clinical trial professionals?

It is already being explored in proof of concepts in patient data and supply chain. For the patient data element, it's almost obvious because there are sensitive forms of patient data like genomic data that requires that level of protection in terms of coding and encryption, which is already happening. But also it's a very clunky system where you collect samples every single time you want to perform analysis where those samples also don't change. So it is important to understand how to repurpose those types of data forms. And so that value is already being piloted by several companies.

And from a supply chain point of view that's is applied in other industries such as consumer goods and retail, it is a case of and transferring process flows in logistics and the track and trace elements, and also authentication, especially for fraud prevention. It is something that can benefit the supply chain, not just within clinic research but all the way down to post-marketing. Once the drug is out there it is important to make sure that the continuous surveillance of compliance for making sure quality is intact, making sure that there are no breaches in the delivery, not just in terms of the fake medication coming out to patients but in terms of even within that process, cold chain for example, that there are no breaches in predetermined conditions.

So those are areas that I think will be at least advancing faster than other areas such as vendor payments and other kind of automated systems that you could build smart contracts around.

What do you think is the greatest advantage blockchain provides to the industry? Are there examples of it being used today?

I really quite strongly believe that we as an industry need to come together and collaborate a lot more, and this type of activity is opening up avenues for collaboration. We have been trying to advance this way of working across the industry within the PhUSE group. For PhUSE phase one we managed to deliver our whitepaper, which was a collaboration with seven pharma companies, regulators, academia, and consulting companies, and we have now taken it to the next level. Initially we thought, “Oh gosh, this is the first time pharma's coming to collaborate without having any formal governance and payment structure or strict guidelines to follow that limits free thinking.” We wanted to do this in a very different and more fluid way, and we managed to achieve that.

This year we have progressed into PhUSE phase two and we have now got vendor partners to join us and collaborate with each other. And that is interesting because we have taken all of our learnings from our phase one on how to build strong teams that come from competing parties to work together. To really advance this technology and development, we are now at a level where we are now getting our vendor partners to collaborate and co-create joint products. And it is something that is open source that we can really learn about together, and it is not requiring a massive investment from anyone apart from our brains, I guess, and our time and our enthusiasm.

So I think this is something I want to really support and continue to advocate, that people in the industry need to start thinking in this way. If you have an idea, there is bound to be somebody out there who is thinking about something similar and it is important to—so long as it's not obviously competing with something that you protect—put a lot of effort and energy into trying to progress using the absolute power of collaboration.