Maintaining security and privacy is a major challenge within the clinical research industry. Blockchain technology could address that challenge, by enhancing data integrity.  Blockchain is best known as the infrastructure behind crypto-currency transactions, however it also offers significant advantages for any environment where sensitive data is captured and shared.

Unlike traditional databases, where a single resource holds and manages all of the data collected, blockchain is a peer-to-peer network of ledgers. Each ledger in the chain stores a block of data, creating a permanent digital history with a unique hash ID that can be viewed by anyone allowed on the network and that ledger. Each individual is given a digital “key” which authenticates any transactions they make on the network and more importantly, their data within each block.  This decentralized approach means no single individual controls the data, and if anyone tries to alter any piece of data, everyone on the network can see that it has been changed, thus enhancing security and privacy.

What does this mean to clinical research?

Blockchain has significant implications for data security, data privacy, and data verification in a clinical research environment. The virtually immutable environment of blockchain means patient information can be instantly stored, verified, and protected from misuse.

One of the largest hurdles in drug and device development today is addressing the vast concerns around data integrity, data transfer and data transparency.  As the use of mobile devices, sensors and wearables continues to reshape how we conduct research, it will be critical to safeguard data within. Additionally, the need to validate the structure and ‘chain of custody’ for clinical research data is required. The question at large for the life sciences community is, ‘how will this be reasonably accomplished?’

Examples of blockchain across all phases of development

Blockchain offers solutions that can be leveraged across the clinical trial.  During recruitment periods, patients can be remotely enrolled in a virtual trial, and all individual health records can be stored in the blockchain to be accessed and validated upon consent. The blockchain ensures  informed consent has been captured from the identified patients, and not an imposter or stand-in.

During the trial, the investigative product can be traced from inception to consumption at an individual patient level, ensuring quality is documented and maintained. In addition, using remote patient authenticated mobile and wearable devices, validated patient data can be securely captured real-time and immediately retrieved by relevant stakeholders with verified identities and qualifications within the blockchain. The blockchain also allows safety monitors the ability to  review adverse events and trigger notifications to verified stakeholders within seconds for further processing, while patients in a medical crisis can also provide ER physicians with access to their blockchain so they can understand how the treatment may be affecting their health status.

These are just a few of the data management scenarios that are possibilities for sponsors who leverage blockchain as part of their clinical trial environment.

Pilots and auditors

Current trends in the industry indicate that blockchain usage could soon be a reality. The US Food and Drug Administration (FDA) is actively evaluating the use of innovative technologies, including artificial intelligence and blockchain, to drive clarity and efficiency into clinical research, to improve traceability in the supply chain, enhance data integrity, and privacy.

A few pharma companies have also started to test the benefits of blockchain in a clinical setting. In February, Boehringer Ingelheim (Canada) announced a partnership with IBM to integrate blockchain technology into clinical trials. Their goal is to validate blockchain technology’s ability to enable data integrity, transparency, and patient empowerment to improve quality and safety while reducing costs.

The 2019 DIA conference in San Diego held several workshops and events exploring potential applications of blockchain, including a forum on technologies transforming clinical research, a session on how life sciences can leverage blockchain, and a workshop demonstrating how blockchain can be used for patient verification.

Implications moving forward

All signs point toward growing excitement around blockchain’s potential to address many of the data security challenges our industry faces. However, its use in this environment is still very new, and many sponsors are wary of whether regulators will embrace this new data management environment. While regulatory decision-makers may recognize the benefits of blockchain, we must be sure field auditors are trained on how it works as there is a concern they will challenge the acceptance of clinical data captured in a blockchain, despite the proven security features. It is important for companies who embrace the use of blockchain to clearly define its intended use and the types of data they intend to protect.

Such fears are a common part of adopting any new technology, particularly in such a highly regulated environment. Fear can be alleviated by starting with pilot projects that capture a subset of low risk clinical data in a blockchain as well as working with quality auditors and regulators during trial planning to ensure they approve of the blockchain strategy. It will be imperative to develop an overarching quality governance focused on the oversight and integrity of data produced at all stages of clinical research. Companies must also show control over blockchain’s intended use by applying pre-defined computer systems validation and robust change management processes.

Embracing this iterative approach will make it possible for sponsors to work out the kinks, and prove to decision makers that this technology is safer, more transparent, and easier to manage than many of the data management tools that we use today.  

See also: The Future of Blockchain in Healthcare

Written by:
Julie Ross
President
Advanced Clinical

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Julie is a tenured executive leader responsible for all aspects of strategic planning, corporate alliances, sales and marketing, operations, financial management, and regulatory compliance at Advanced Clinical. Previously with inVentiv Health Clinical, Ms. Ross served as Senior Vice President of Global Strategic Services and had oversight of Feasibility, Patient Recruitment and Retention, Global Study Start-up, Document Management and Publishing, Expedited Safety Reporting, Grants and Contracts, Clinical Trial Supply Management, and Medical Writing. She has a therapeutic specialty in urology and gastroenterology and has consulted with many clients developing products in BPH, MED, OAB, and IBS.