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Blockchain is moving toward definitive uses in clinical trials to enhance clinical supply capabilities, with the potential of enabling data ownership for patients.
Applied Clinical Trials
has featured articles and discussion around the concept of blockchain (
) and (
). But it’s becoming a bit clearer that blockchain is moving toward definitive uses quickly in the clinical trials world.
At the recent CBI Interactive Response Technologies (IRT) 2018 conference, Imran Shakur, Senior Manager, Clinical Supply Capabilities for Biogen, and Chad Sklodosky, Director, Digital Clinical Supply Chain at Pfizer presented on the topic “Leverage Blockchain Technology to Enhance Supply Chain Management.” Sklodosky described a November 2017 blockchain workshop held at Pfizer’s Research Technology Center in Cambridge, where over 50 participants from various companies discussed 12 use cases, of which two working groups were advanced.
The one discussed at this conference was the Clinical Supply Blockchain Working group, whose long-term vision is to “develop a fully interoperable, transparent, and auditable platform that enables Investigational Product (IP) to be tracked from point of manufacture to the point of which it is consumed by the patient.” Sklodosky outlined the working group’s timeline around clinical supply, with the 2023 goal of having fine-tuned a process that will be scalable to the ecosystem.
The second use case that the group decided to advance was patient data donation and clinical research, which was not presented at this conference, but more can be learned from this paper issued by Deloitte and Pfizer (bit.ly/2OnmVm8)
In this outline, the patient becomes the owner of their data and chooses where that data is stored and shared in the trusted blockchain network. As the paper points out, the patient could seek out clinical research opportunities or donate their data to research efforts. While CISCRP has conducted many studies on the altruistic reasons people participate in clinical trials-to help others benefit-this data donation would surely take that step one further.
Hu-manity.co agrees that data ownership is fundamental, however, it also believes individuals should be paid for their data. I refer to this news blurb, bit.ly/2DnpiEo, and this longer article about one of the co-founders, bit.ly/2zqlD4i. Hu-manity.co is partnering with IBM to use its blockchain platform as its global consent ledger, whereby people will manage consent, authorization, and commercial use of their personal information. This information is not limited to medical, health, or research data, but is definitely a part of co-founder and COO Michael DePalma’s larger position, as quoted in the referenced article. He also says in the article “there is a massive amount of valuable data being generated, but none of the profits are being filtered back to the people who create the value.”
In the business case use above, data ownership is not the question. Those that consent into the private clinical supply chain process participate around the data flow. Interestingly, during Shakur’s presentation he said that blockchain in this case could appear to be doing away with IRT. However, he explained that IRT is actually blockchain “lite” and experts in IRT are needed to guide the forward solution.
While the way data is collected and stored in this industry evolves from legacy to cloud-based systems; integration issues and actionable insights around data, it’s the data itself that is moving into the center stage.