Contributed Commentary by Mike Novotny

September 19, 2018 | The healthcare industry has been home to some of the most remarkable innovations in modern history, yet is behind most other industries in implementing new technology. Consider electronic data capture (EDC). The inception of EDC in clinical trials dates back decades, but only recently has its use become standard throughout the industry.

In this context, it’s surprising to see blockchain—an innovation most notably associated with cryptocurrency—catch the attention of organizations and professionals in the healthcare space. In a late-2016 Deloitte survey, 35% of respondents in the healthcare and life sciences industry expressed plans to implement blockchain within the next year, outnumbering respondents in industries including manufacturing, financial services, and media who expressed similar plans. Respondents in healthcare cited clinical trial records among the top three areas in their industry that could benefit from blockchain.

For many in the clinical research and broader healthcare industries, however, blockchain remains a vague concept with unclear benefits. What is blockchain, exactly? What are its benefits for clinical trials, and what are some important considerations before clinical research organizations can fully take advantage of those benefits?

Understanding Blockchain In Clinical Trials

The central purpose of blockchain is to store digital information on a distributed network to make a shared and continually reconciled database. In essence, blockchain is a distributed electronic ledger that keeps track of data, whether that data is related to financial transactions, product inventory, healthcare data, or anything else. One of its most valuable features is that it guarantees the validity of a transaction by recording every change across the entire distributed network.

One can imagine the applications of something like this in a modern clinical trial setting, in which so much depends upon having a fast, easy, and transparent way to locate and share large quantities of data with specific individuals, often across long distances. Blockchain is perhaps most immediately applicable to clinical trials through audit trails. Good clinical practice requires as much transparency as possible regarding where and when data was entered, and by whom—as well as other information such as who has permission to access what data. Audit trails provide this insight, and blockchain can take it to the next level by improving privacy, security, and transparency.

The benefits of being able to control access to data via a decentralized ledger like blockchain are many, not least of which is that it would make operations at sites, CROs, and sponsor organizations much more efficient. While industries are still coming to terms with the security implications of the technology—there have been, for example, several blockchain hacks in the cryptocurrency world—organizations can protect against risk by keeping their blockchain technology private rather than publicly distributable.

What About The Regulatory Side?

Slow adoption of technology in healthcare is often the result of the regulatory scrutiny the industry works under. This scrutiny is no surprise: the work of researchers and developers of medical products, after all, has a tremendous impact on public health. As a result, any time a technology from outside the traditional eClinical space enters a clinical research setting, compliance becomes a major question. Will the use of blockchain—or other innovations such as mHealth, wearables, AI, and bring-your-own-device, for that matter—meet the regulatory guidelines that were developed around the use of EDC, eSource, and other traditional eClinical platforms?

The first regulatory question raised around a publicly-accessible data storage network like blockchain is likely to center around data security. Clinical trials contain a wealth of sensitive data, whether it’s proprietary information on a medical product’s safety and efficacy or personally-identifiable information belonging to clinical trial patients. Implementing new ways of storing and accessing that data raises important questions and concerns about security and accessibility. But one of the things that makes blockchain so groundbreaking is its ability to make data completely visible, completely password protected, or somewhere in the middle. Users can allow access to certain pieces of information while blocking others.

The implications for clinical trials, in which there has long been a tug-of-war between those advocating for increased data transparency and those fighting to keep sensitive data private, are significant. This can go a long way toward, for example, enabling researchers to meet regulatory requirements around reporting clinical trial results without putting personally-identifiable information at risk.

Clinical trial regulators have already started work to pave the way for blockchain. The FDA, for example, spearheaded an initiative last year to define the best way of using blockchain to exchange health data. With these efforts underway, and with the potential of blockchain becoming increasingly clearer, we could be on the cusp of a new era of data storage in healthcare and clinical research.

Mike Novotny is the founder and CEO of Medrio. Mr. Novotny applies 20 years of experience in research and software to his eClinical SaaS vision. Prior to founding Medrio, he was president of Ninaza, an EDC software company, and previously held roles at the U.N. and at VISA. He holds a BA from Stanford University and an MBA from Columbia University. Mr. Novotny can be reached at mnovotny@medrio.com.