In a previous article, we introduced clinical trials and explained why they are so important to our health systems. In this article, we address how blockchain can help tackle some of the issues that make today’s clinical trials overly complex, lengthy and inefficient.

This article is the first in a three-part series on blockchain in clinical trials, and was adapted from the Triall whitepaper (which you can download by following this link). Triall’s mission is to enable a future of smarter, safer and more-efficient clinical trials by delivering blockchain-enabled solutions for clinical trial professionals.

Blockchain: the next paradigm shift in information and communication technology?

As blockchain is being explored and adopted by more and more startups, large companies, and governmental organizations, many consider it to incite the next paradigm shift in the way we exchange and communicate data and information. The technology that has become famous for underpinning cryptocurrencies is now being leveraged in various ways. Many of these center around bringing trust, integrity, and automation to processes that require a multitude of independent stakeholders to collaborate efficiently and safely across organizational boundaries and data systems.

Blockchain ledgers can be used to offer indisputable proof of data being recorded at a set time under a verifiable condition, or to automate and streamline the execution of contractual agreements by programming these into blockchain-registered smart contracts. But blockchain ledgers can also function as a trusted layer for cryptographic identity and access management, making use of so-called Decentralized Identifiers (DIDs): unique blockchain-registered identifiers that enable decentralized verification of identities and their credentials.

We’ll address DIDs and their relevance for clinical trials in the second part of this article series. In the current part, we’ll cover blockchain’s functionalities with regard to data integrity, traceability and auditability.

The first clinical trial on the blockchain

Did you know Triall is the world’s first organization to implement blockchain technology in a live and running clinical trial? Read about it here.

The value of blockchain for clinical trials

Clinical trials require efficient communication of sensitive information among many different specialty stakeholders

So how does all of this relate to the clinical research industry? Clinical trials involve many different specialty stakeholders often spanning organizational and national boundaries. To illustrate, a typical ‘Phase 3’ clinical trial may comprise over 50 research sites across more than 15 countries. Clinical trial stakeholders are seen to operate in relative isolation, each applying their own software systems, data formats, workflows, and organizational structures. Furthermore, they are reluctant to share clinical trial-related data and documents across organizational boundaries in fear of security and privacy breaches.

Clinical trial data volumes are increasing

At the same time, clinical trials are becoming increasingly data-heavy. A phase 3 trial now collects over 1 million data points, which is roughly double the amount observed 10 years ago and this trend is likely to increase. Whereas simple paper and electronic forms used to be the only sources of clinical data in the past, the emergence of electronic health records, wearables, and other smart mobile devices is spurring the number of data inputs in a clinical trial. To safeguard the safety and quality of medical solutions, rules and regulations stipulate that all data events are meticulously documented.

Clinical trials are complex, lengthy, and resource-inefficient

It follows that the increasing complexity and digitalization of today’s clinical trials as well as the high number of segregated stakeholders lead to various process inefficiencies. The following sections will address some of the consequential persisting issues currently experienced by the clinical trial industry and will explain how blockchain technology can play a fundamental role in tackling them, focusing on data integrity, traceability, and auditability.

Data integrity — Assuring authentic clinical trial evidence

In accordance with international Good Clinical Practice regulations, the many stakeholders involved in a clinical trial are required to store trial-related documents and keep a record of document changes. These may be subject to inspections by sponsor representatives (independent monitors) and regulatory authorities at any point during a trial to verify the quality and integrity of the trial’s operations. Ultimately, the clinical trial documents combined should provide regulators with conclusive evidence that the investigational product is safe and effective, and qualifies for market introduction.

Fraud and misconduct

Unfortunately, fabricated or concealed clinical research data continues to be an issue. Over recent years, marketed drugs have been recalled for lacking safety or efficacy on several occasions, putting clinical trial subjects and patients at risk. Whereas the pharmaceutical industry was once held in high regard for its pivotal role in the advancement of human health, these cases of error or misconduct as well as other negative media coverage have reduced trust in the industry among both consumers and regulators. As a result, clinical trial stakeholders experience problems with recruiting patients in their clinical trials and these issues have led to even more stringent regulatory requirements, adding to the burden of documentation for clinical research professionals.

Blockchain: authenticating clinical trial documents and data

A blockchain ledger can function as an immutable and cryptographically secured reference database against which trial-related documents can be compared in encrypted form. By creating and registering hashes of essential documents on the blockchain, while the original documents remain in their secure private repositories (please note that personal identifiable data is never stored on the blockchain!), users can prove that their documents and data have not been modified after registration. An identical document or data point produces the exact same hash code.

If a certain document produces a hash code that does not match the hash previously recorded and timestamped on the blockchain, this indisputably proves that the document has been changed. Using this simple mechanism, auditors (regulators, monitors, inspecting authorities) can verify that trial-related documents and data have not been altered or modified over the course of clinical development, which can take up to 10 years.

Blockchain technology thus becomes a means of promoting data integrity, by helping to assure the accuracy and consistency of data over its entire life-cycle. Those interested in manipulating the data set would find it near impossible to do so in a system that assures data cannot be altered as soon as it is collected. They would still be able to enter forged data, but this would be of no use since the significance of a clinical trial data set almost always only becomes clear after data collection has been concluded and the data set is ‘de-blinded’ for analysis (which shows how the investigational product and the placebo product are distributed across the pool of research subjects).

Traceability and auditability — Establishing an immutable audit trail of documents and changes

Lack of oversight for the majority of the industry

Academia and smaller industry players often lack the necessary technological infrastructure to support their clinical trial activities. As a result, this group (which conducts the majority of clinical trials) is hampered by a lack of oversight on their clinical trial processes and activities. These parties have no easy and secure way of viewing the complex network of data exchange, no real-time access to results as they are being made and no easy way to trace data back to its original source. In response, the U.S. Food & Drug Administration (FDA) has listed lack of data traceability as one of the top data issues in today’s clinical trials.

Costly reiterations along the clinical development chain

While academia and smaller industry typically perform the early stages of clinical development (phase 1–2), Big Pharma’s involvement is essential for completing the later stages (phase 3), ultimately bringing a candidate medical solution to market. Contrary to their smaller counterparts, Big Pharma companies are commonly supported by fully-integrated and all-encompassing technological infrastructures that help them maintain oversight and auditability. Nevertheless, when taking over projects from academia and smaller industry, they are often forced to reiterate research activities as they cannot ensure data quality and validity due to documentation and data inadequacies in previous trial phases. This results in an enormous amount of unnecessary costs and ultimately delays time to market as well as driving the commercial price of the medical solution under investigation.

Blockchain: enhancing data traceability and auditability

Blockchain technology enables clinical trial stakeholders to establish an immutable audit trail of documents, and data entries and their evolution throughout the entire timeline of clinical development. This functionality can revolutionize clinical trial data management by enhancing the traceability, auditability, and quality of clinical trial recordkeeping and data management. It fits perfectly within clinical research guidelines and regulations, which emphasize the importance of version control and state that previous entries are not allowed to be obscured under any circumstance. Moreover, it also improves the value proposition of smaller industry players who can now indisputably proof to potential partners when and under what condition their clinical trial data has been recorded.

In conclusion

Blockchain technology allows us to rethink the ways we organize business, networks, economies and the society at large. It promotes trust in a way that is radically different from current models, reducing the need for centralized regulators.

A one-stop solution?

But even though blockchain’s transformative impact is expected to be profound, the technology is not a panacea to all data integrity and trust-related issues. Blockchain should be implemented in conjunction with ‘traditional’ time-proven technologies, while following industry best practices and quality guidelines the world has so carefully developed over the past decades. When contemplating the use of blockchain, organizations should therefore always first consider whether a particular problem can also be solved using existing technologies (don’t be a blockchain solution in search of a problem) and whether implementing blockchain would actually ease the life of the end-user. Moreover, it is important to take note that for most data entries on the blockchain that are not related to monetary transactions (as these are validated by the network), data validation steps should still be conducted off-chain since the ‘garbage in, garbage out’ rule also applies to this technology.