Blockchain in clinical trial supply chains: more hype than substance?

Blockchain technology, which safely and securely records valuable data, has emerged as a solution for transparently tracking complex supply chains. However, many experts doubt that pharma – usually a conservative and tightly regulated industry – will implement or benefit from this technology.

Experts say the pharmaceutical industry has little appetite for investment in blockchain, especially given the more promising options for supply chain tracking, such as radio frequency identification (RFID). Meanwhile, pharmaceutical supply chains are already heavily regulated, so the industry cannot benefit from blockchain the way other industries can.

“Blockchain is a big buzzword, but it’s not necessarily the answer in biomedical supply chains,” says Dr. Atul Butte, computer scientist at University of California Health. “There are many other proposed solutions out there.”

Can blockchain offer supply chain benefits?

Blockchain is a digital record-keeping tool, where every piece of data added to the blockchain ledger is transparent and secure, explains Chi-Ren Shyu, director of the University of Missouri Institute for Data Science and Informatics. All entries on a blockchain are immutable, making it impossible to retroactively manipulate data after it is recorded, he adds.

In pharmaceutical supply chains, blockchain can guarantee the reliability of all data recorded at each step of the supply chain, from the raw materials sourced to the doses at a trial site, says Shyu. However, it is not necessarily clear that reliability is a major concern in pharmaceutical supply chains in the first place, he notes.

Countries with large drug markets have tight regulations, so blockchain’s immutability doesn’t provide a huge trust advantage, Butte adds. Additionally, the transparency of blockchain is not necessarily an advantage in the clinical trials sector, he notes. Details of drug supply chains, including sensitive patient data such as whether a drug is an active treatment or a placebo, should still be secured in private databases, he explains.

Pharma slow to adopt

Although blockchain significantly improved the reliability of drug traceability, there are big questions about whether pharma would trust the new technology, says Shyu. Pharma is conservative when it comes to adopting new technology, especially when there are few use cases in other industries, he notes.

If blockchain sees widespread implementation, pharma will be among the latest industries to adopt, notes GlobalData analyst George Monaghan. “Blockchain skepticism is high at the moment,” he adds. GlobalData is the parent company of Clinical Trials Arena.

According to a 2022 GlobalData survey, which recorded responses from 114 pharmaceutical executives, only 6% reported prioritizing investments in blockchain. Meanwhile, 51% of executives reported prioritizing investments in artificial intelligence (AI), 39% in real-world evidence (RWE) and 18% in the Internet of Things (IoT).

Still, adoption expectations for blockchain have increased over the past year, notes Monaghan. In 2022, 21% of pharmaceutical executives said they could use blockchain within the next two years, up from just 13% in 2021, according to the GlobalData survey.

Alternative solutions to blockchain

Despite the skepticism surrounding blockchain, pharma may require changes to supply chain verification to meet stricter new regulatory requirements. In November 2023, the FDA’s Drug Supply Chain Security Act will go into effect, requiring device-level tracking of all drugs dispensed to patients.

As an alternative to blockchain in pharmaceutical supply chains, drug manufacturers can widely implement RFID, notes Butte. RFID uses radio waves to track individual drugs, materials and shipments with much greater precision than barcodes, allowing sensors to efficiently scan hundreds of individual devices simultaneously. Meanwhile, there is also research into adding quick response (QR) codes to pills to promote greater traceability of the drug, Butte adds.

Blockchain does not solve the problem of who owns the data management system for clinical trials, explains Butte. As a result, private secure databases, combined with more precise tracking mechanisms, may still be pharma’s best option, he says.

The future of blockchain?

Beyond pharmaceutical supply chains, there is also some interest in blockchain as a tool for recording data from clinical trials. The industry-wide push toward decentralization of clinical trials has raised concerns about patient control of data, and some companies are promoting blockchain as a tool to give patients more control over their data.

In terms of supply chains, the COVID-19 pandemic has highlighted the need to improve and digitize pharmaceutical supply chains. But at least for now, many industry experts don’t expect blockchain to lead the charge.

“My eyes are wide open to possible changes,” says Butte. “I just don’t see any strong use cases where blockchain can improve biomedical supply chains more effectively than the alternatives.”

Takeaway:

• Blockchain is a digital record-keeping system that is secure, transparent and immutable, potentially improving reliability in clinical trial supply chains.
• However, many experts are skeptical that pharma is ready to invest and see additional benefits in an already regulated industry.
• Pharma is a conservative industry, and biotechnologies have not prioritized investments in blockchain over other emerging big data technologies.
• Experts expect pharma to digitize supply chain tracking further, but most likely through less risky alternatives such as RFID traceability.

More on supply chain for clinical trials: Sustainable supply chains: clinical trials in a new era of limited resources.