Blockchain technology is revolutionizing how data integrity is ensured in clinical trials by offering a transparent and secure way to record and access trial data, increasing trust and compliance.
Regulatory bodies such as the FDA and EMA are committed to upholding data integrity in clinical trial research, and rightfully so. Neglecting proper data integrity protocols in the collection, storage, and analysis of trial data can jeopardize the safety and effectiveness of products and compromise patient confidentiality.
With remote and decentralized trials becoming more commonplace, protecting the integrity and security of data is more critical — and complicated — than ever. Clinical trials have become increasingly intricate, yet much of the industry has failed to take advantage of advancements like blockchain technology that could lead to faster approvals and better patient outcomes.
Blockchain Brings Real Value to Clinical Trial Management
While some companies have transitioned to paperless processes, many still hesitate to embrace purpose-built digital solutions that utilize cutting-edge technologies like blockchain, machine learning, and data analytics. These innovative solutions have the power to propel clinical trials forward while simultaneously ensuring regulatory compliance for manufacturers.
The potential of blockchain technology is immense, and blockchain's integration into clinical trials could be a game-changer in the pharmaceutical industry.
"Blockchain technology presents a unique opportunity to address common threats to the data integrity collected in clinical trials..."
Study Recognizes Blockchain as an "Innovative Tool in Data and Software Security"
According to a study published by the National Library of Medicine, which delved into the potential of blockchain technology in facilitating clinical trial data management, it was concluded that "blockchain technology presents a unique opportunity to address common threats to the integrity of data integrity collected in clinical trials and ensure that the analysis of these data comply [sic] with prespecified plans." (1)
The 3 Biggest Benefits of Blockchain Technology
Before we examine the value blockchain technology brings to clinical trial management, let's define it. Simply put, a blockchain is a bunch of blocks linked together. Each block contains data that can be linked to another block, forming a blockchain. The link is secured by a unique key (cryptography that includes a hash and a pointer). A distributed ledger keeps track of everything.
The benefits of blockchain when it comes to clinical trial data are:
- Blocks of data are immutable and can be relied upon.
- The data can be traced back to the source.
- The blocks of data are secure.
Blockchain technology creates an unchangeable and cryptographically linked transaction record, establishing a definitive and trustworthy source of information over time.
With blockchain, clinical trial data can be relied upon, traced back to its source, and protected from unauthorized access. This technology brings a new level of data integrity and security to the pharmaceutical industry, ensuring that crucial trial data is accurate and trustworthy.
Using Blockchain to Ensure Quality Product Data and Maintain Data Integrity
When we combine blockchain, data integrity, and digitalization, we begin to deliver on the ALCOA attributes: Attributable, Legible, Contemporaneous, Original, and Accurate. Here's how:
ATTRIBUTABLE: With blockchain, you can trace data back to its source. This ability to trace data lineage is a significant advantage in clinical trials. By leveraging blockchain technology, researchers and regulatory bodies can have complete visibility into the entire lifecycle of trial data, from its origin to the final analysis.
LEGIBLE: Digital information is more legible and easier to decipher than handwritten data. This applies to all types of data that adhere to standards and protocols, such as ASCII, JPEG, PDF, XML, etc. Garbled or illegible data can be promptly identified. Furthermore, a digital system can automatically validate data at the point of capture, which helps ensure legibility.
CONTEMPORANEOUS: Digital information is more contemporaneous than handwritten information because it is captured at a "point in time." True, it can be recorded later, but that is why timestamps and secure logins are so important; they make it easy to trace back to the individual responsible for the data. All participants have access to the same version of the data. Any changes to the data are visible to all stakeholders, allowing for better data integrity checks and ensuring the data hasn't been manipulated.
ORIGINAL: The fact that blockchain will trace back to a source helps ensure originality. By allowing multiple parties or systems to contribute to the blockchain, verify it against the ledger, and validate the link (including pointers, encryption, and hashes), as well as the block data itself, an intrinsic system of checks and balances is established.
ACCURATE: The accuracy attribute is the least reliable when considering the ALCOA attributes and how blockchain can contribute. However, this is not a significant problem but something to be mindful of and address. There are alternative methods to ensure data accuracy, such as leveraging the functionality of smart contracts, which are self-executing contracts with predefined rules and conditions. These contracts can contain logic executed by another system to validate the data itself, offering a potential solution to the accuracy challenge.
According to Gartner, on average, poor data quality costs companies $15 million annually. From a financial perspective, enhancing data quality can significantly benefit a company's bottom line.
Applying Blockchain to Achieve "Data Integrity by Design"
We've discussed how the immutability of blockchain makes it excellent for data integrity because it proves that data is original, unchanged, authentic, and verifiable. One minor change invalidates the entire chain making it easy to identify which change or corruption occurred and where. This can apply not only to validation data but also to audit trails.
For clinical trials, personally identifiable and personal health information are sensitive, and blockchain controls access by allowing and revoking access. But this must be designed into the application, which is data integrity by design.
Pharma Companies Using Blockchain Technology
The Blockchain Technology in Healthcare Market Report 2023 lists Pfizer, Sanofi, and Novartis as some of the pharmaceutical companies using blockchain technology to enhance operational efficiency, expedite research and development, and decrease the costs associated with drug development.
As the use of blockchain technology in drug development continues to gain traction among pharmaceutical and biopharmaceutical innovators, it opens up lucrative opportunities for those involved in the blockchain market for drug discovery and clinical trials. Projections indicate that this market will experience a robust growth of over 22% in the next decade, with the potential for widespread adoption across different types of blockchain, end-users, and geographical regions. (2)
Integrating Blockchain with Other Technologies and Use Cases
The versatility of blockchain technology goes far beyond its application in clinical trials. Integrating it with other cutting-edge technologies like artificial intelligence and the Internet of Things (IoT) can impact the efficiency and effectiveness of validation and quality control efforts.
We truly are living in exciting times!
- “Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study”, National Center for Biotechnology Information. Accessed on August 1, 2023.
- “Blockchain Technology in Healthcare Market: Distribution by Type of Blockchain, Type of End-User, and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2025”, Research and Markets.com. Accessed on August 1, 2023.