Blockchain Concepts Emerge in Clinical Trials

The application of AI, blockchain technology, and machine learning in clinical trials is sparking a lot of interest in the biopharmaceutical industry, and there was much discussion on the topic at PanAgora’s AI & Machine Learning in Clinical Trials Summit last month. In this interview, Munther Baara, Head of New Clinical Paradigms at Pfizer, will discuss his perspectives on how blockchain may impact clinical trials. PanAgora’s Clinical Trial Patient Experience Summit is occurring September 12-13, 2018 in San Francisco.

Moe Alsumidaie: Can you describe blockchain technology?

Munther Baara

Munther Baara: To start, it is important to note that, although the two are often discussed in tandem, blockchain is not cryptocurrency (e.g., bitcoin). Rather, blockchain is the technology on which cryptocurrency is built. Blockchain is a distributed ledger, which means each party in the blockchain network has access to-and control of-the entire ledger and its complete history. For example, if I have 1,000 copies of the ledger, each computer is a supervisor of one of the remaining 999 copies of this. Unlike the internet, blockchain is built from the ground-up with security in mind. So, blockchain offers a distributed database, which requires the use of cryptographic technology with an encrypted public-private key, to identify, authenticate, and authorize to execute transactions. That transaction then gets validated by a hash algorithm, and it’s immutable, meaning the records cannot be modified or deleted, only appended.

The pharmaceutical industry is interested in exploring whether blockchain may provide better data transparency processes, including an audit trail, in real time. The blockchain also embeds a smart contract, or self-executing contract, between the consumer and producer, which is written into the code. With these three elements combined-multi-user control, immutability, and efficient contracting-blockchain has the potential to help the industry aggregate data in a secure, trusted, and automatic way.

MA: Is blockchain being used in the health care or biopharmaceutical industries now?

MB: In the US, there have been some pilot programs, but I haven't seen full-blown implementation as the technology is still relatively new. However, I have seen more implementation in Estonia, where much of their electronic health records utilize blockchain. Estonia’s voting and national ID systems are already fully electronic.  In response to hacking attempts, Estonia developed blockchain technology to secure all its electronic health records and financial information. Canada and Austria are also working on blockchain implementation, and interest is growing around the world.

MA: Is blockchain a fad or is it here to stay?

MB: Blockchain is the next generation of the internet and-coupled with AI, machine learning, and predictive analytics-it may offer more control to individuals and companies.  

MA: How do you envision blockchain use in clinical trials?

MB: If clinical trials can employ blockchain technology, the aggregated data would be immediately available when a patient enrolls in a study, which can save time during screening. Research sites and sponsors would have the ability to view original and quality source documentation in real-time, which minimizes medical history data errors. Another benefit of using blockchain would be the ability for patients to better connect with individuals who have similar conditions (e.g., in rare disease populations), which can enhance trial referral potential. The drug supply chain could also be a great area where the industry can track investigational products all the way from inception to consumption, connect to the patients to gather medication adherence data, and facilitate drug accountability documentation. Sponsors can also use blockchain to register clinical trials and share study results with other researchers. Blockchain has the potential to be a game changer, as it would change the way we conduct business, not only in pharma but also globally across other industries.

Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.