Blockchain in Clinical Trials

Doug Bain, Chief Technology Officer at KCR

This morning, I was on the verge of posting the following;

Block Chain in clinical trials software — 1% patient functional impact. 0.25% software development user stories. 20% marketing messaging. Now lets get back to work…

However, that is a simplification of the value of blockchain in clinical trials. This is probably true from a software development perspective, but the impact might be greater. Lets discuss…

Historic use of blockchain methods

I am going to attempt to describe the historic use of a blockchain style method in a clinical trial system.

I am going to go back in time to when EDC was typically online / offline. This was when the internet was in its infancy. We could communicate through the internet, but it was patchy at best. The term blockchain had yet to be invented. This example comes from a product I was latterly responsible for — IBM Clinware RDE (EDC).

The challenge we faced was that we had computers running software at investigator sites that had to work securely. We didn’t want the database tampered with. We used blockchain technology to achieve this. Here is the principle.

An audit trail in the EDC system — well known today of course as it forms part of the FDA regulation 21 CFR Part 11 — holds a record of changes to values. In many instance, it holds records of all actions. It became what is often referred to as a Transaction Log. Blockchain today calls them Ledgers.

In our particular system, not only did we store the values in the log, we used one way encryption to store an encrypted copy of the data being stored. This encrypted value could be compared at any time against the unencrypted value to check whether the data had been tampered with.

The second step we took was to store not just an encrypted copy of the current record. We also stored an encrypted copy of the previous record in the stack of records. What this meant was that if either the value was changed, or, the order of records were changed, then we knew tampering had occurred. This is basically one of the premises of blockchain though simplified.

The reason this was used in offline Site EDC was that we needed to ensure the integrity of the data even though the database was stored on potentially an open computer.

Roll-forward 25 years and we have a similar requirement for patients. A patient might be asked to complete a symptom diary. At the time they suffer the symptom, they are offline. They need to be able to record the symptom without an internet connection. So… we need to store the data locally, in their phones memory.

Of course, this memory is likely to be well protected itself. However, the protection is only as good as the person using it in a BYOD (Bring Your Own Device) situation.

So — blockchain could potentially have a function similar to our use of the method in Clinware for things like eConsent, Diary entries or Wearables data storage.

Identity Assertion

Our next challenge that is applicable to our use case for blockchain — patient data capture — is to ensure the initial and ongoing identity of the patient and other interacting parties. Blockchain is not a complete solution to this but could help facilitate this through the secure sharing and assertion of the ‘blockchain’ across multiple replicating parties. The difference between the official definition of Blockchain and the Clinware implementation described above is that multiple parties can assert the validity of a blockchain. In a clinical trial, the actual parties that could provide the assertion would be limited to a site asserting the patient and the sponsor asserting the site. In a single instance platform, we might have additional assertions of the validity of a site and a sponsor.

Blockchain for process contracts

This is not something we did with Clinware, but something could be done to expand on the work we did with the Clinpal platform. Clinpal makes extensive use of configurable workflow to control the lifecycle of forms, patients, sites and users. We also see extensive use of workflow in the Veeva Platform.

One challenge that we see is that these platforms have no means of asserting and supporting external parties that wish to participate in a workflow activity. For example, a step in the lifecycle of a patient might be to send some data to a lab for processing. Today, the activities that occur between sending and receiving the samples / data to and from the lab are out with the scope of any workflow. We just don’t know if the lab received and is processing the lab sample.

Blockchain might prove useful in maintaining an assertion of the identify of participants in the workflow process and even to log the activities they perform.

Conclusion

So — going back to my initial assertion. Blockchain is a tiny portion of the software and functionality of an eClinical software product, but it might prove useful. The question I would raise is whether the tools that support the development of software with Blockchain are sufficiently mature and efficient to return sufficient net value.

  • This article was originally published on LinkedIn on March 24, 2022*

About KCR:

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, and Warsaw, Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

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This series will feature blog submissions from a variety of KCR leaders on industry news, hot topics and all things clinical research.

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KCR is an international clinical development solutions provider for the bio-pharmaceutical & medical device industries.

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