Blockchain is Coming — Ready Or Not, Expert Warns Clinical Research Site Executives

May 29, 2018

Blockchain technology offers a lot of promise to sites but it can also destabilize those companies that don’t properly prepare for it, a site executive warned her fellow professionals Tuesday.

When Wendy Charles, the operations manager and researcher at Rocky Mountain Poison & Drug Center at Denver Health asked an audience at the MAGI Clinical Research Conference 2018 East in Arlington, VA, how many had heard of blockchain, very few hands went up. When she asked them how many of their companies were already using blockchain in their business, no hands went up.

“This is coming,” Charles said, “and blockchain will be a part of your everyday life in the near future so it’s important to be aware of what people face.”

Blockchain, sometimes called distributed ledger technology, is a decentralized, digital ledger that tracks transactions across computers. (Its best known example is the cryptocurrency Bitcoin.) It’s already disrupting other industries and it’s appealing to site professionals because it offers transparency, immutability, a clear audit trail and “smart contracting” technologies that promise to make recruiting easier and to give subjects more and better control over the data, Charles said.

The technology has drawbacks, though. The first is that it’s not well understood in the profession, Charles said.

“How does a university prepare for this? How does a site incorporate it?” she asked. “Imagine going to your IRB and saying, ‘Our sponsor would like to put our subject data in the blockchain and the IRB will have all kinds of questions and concerns because they are not familiar with this technology. And they may not even know what kinds of questions to ask in order to ensure that there are appropriate subject protections in place.”

Another concern is the legal and regulatory uncertainties around distributed ledgers, Charles said.

“States are still grappling with how to manage the concept of smart contracts — is that a true contract, especially when used for transactions? The state of Vermont, for example, has put forth legislation to allow notaries in a blockchain — is that legal? They’re trying to make it so. More and more states are looking at the legislation and questions of, ‘Is this binding? Who’s liable?’” she said.

Finally, Charles said, the security risks of distributed ledger technology are “not well known.” In June 2016, for instance, hackers made off with $55 million from a blockchain cryptocurrency fund known as the Decentralized Autonomous Organization by exploiting some of its smart contracting code, Charles said.

If site professionals are considering adopting blockchain technologies, they should focus on three main areas, Charles said:

  1. Permission. Public blockchains (such as Bitcoin) allow literally anyone to make a transaction on them; private ones (already used by big banks, for instance) restrict the people who can make transactions on them. Sites will want to think carefully about who can alter a blockchain — the goal is to secure the chain without over-centralizing the data (thus making any security breaches even more catastrophic), Charles said.
  2. Governance. “It’s an ongoing process,” Charles said and “one of the biggest questions for consortium blockchains because if there’s a group of companies that’s getting together to share a blockchain, who’s in charge? Who makes the decision? Who’s responsible for maintenance? Who’s responsible if there’s a problem?”
  3. Security. “There are vulnerabilities at specific points,” Charles said of distributive ledgers. “Try to think about how often you’ll want to have a risk assessment and what kinds of connections do you want to have with your blockchain.”

IEEE, the nonprofit technology group, runs its own web page dedicated to blockchain in clinical trials, Charles said. You can find it here.

-William Myers