Leveraging Blockchain for Clinical Trials/Research

Groundbreaking Technology Key for Improving Clinical Studies, Unlocking and Securing Data and Enhancing Patient Safety and Engagement

When you consider the exorbitant costs and excessive timelines associated with new drug development, it’s no wonder that pharmaceutical companies are eager to improve on the clinical trials process, and more rapidly and thoroughly demonstrate safety and efficacy of new medicines to get US FDA (Food and Drug Administration) or other regional authority’s approval. Many people involved in that process are now exploring how blockchain technology can be tapped to conduct better and faster clinical trials that will accelerate innovation in healthcare, and do so with data governance that gives patients peace of mind, and that can further lead to improved patient engagement and safety.

Why Blockchain?

Blockchain technology allows a network of computers to agree at regular intervals on the true state of a distributed ledger. Such digital ledgers can contain different types of shared data, such as transaction records, attributes of transactions, credentials, or other pieces of information. What’s more, these ledgers are digitized, eliminating paper trails and documentation requirements. Also, privacy can be set to whatever parameter is needed, and data is decentralized on the blockchain so that there are multiple copies simultaneously updated from input at multiple sources. In effect, blockchain offers a solution for clinical trials that surmounts legacy data management platforms, where data sharing amongst various data silos with ensured privacy continues to prove challenging to the point of being insurmountable.

Because all participants on a blockchain have the same viewing capability, and transactions are time-stamped, and are immutable (cannot be changed, only appended), and are replicated in every node providing inputs, all participants can verify the data and confirm its integrity. For clinical trials, ensuring data integrity is a professional and ethical obligation to protect patients and deliver reliable results that can lead to new lifesaving medicines and treatments. Today, blockchain is emerging as a technology that can revolutionize the process of ensuring data integrity. In the position paper, “Blockchain technology for improving clinical research quality,” Mehdi Benchouf and Philippe Ravaud outline the complex flows of heterogeneous data and metadata that circulate in a clinical trial, and demonstrate the numerous healthcare stakeholders and documentation that can be stored safely and securely in a blockchain.

Figure 1. Clinical trial complex data workflow encoded in Blockchain

Unlocking Trapped Data

Healthcare data is no longer just an output from an internal source (i.e., a diagnostic test); it is now also generated from new external sources (i.e., AI, IoT, ML, etc). While there is a good deal of excitement this new data and how it can be used for such things as disease prevention and treatment, precision medicine, and improving patients’ quality of life, questions remain as to how data is stored, shared and protected. The reality is that whether patient health data is generated from a diagnostic test or from newer technologies, the result is the same: the information is typically hoarded in one silo, centralized database waiting to be accessed by a privileged few. As a result, to maintain data privacy, data sharing takes a back seat, so that much needed information cannot be leveraged to improve patient safety and advance healthcare. Blockchain has proven the ability to equally manage data sharing and data privacy through its application of bitcoin. This unique ability affords the opportunity to close the disconnect between clinical and medical to drive innovation in drug development and advance precision medicine.

Creating Inclusive Patient Engagement

There are some daunting facts relating to patient engagement in today’s clinical trials that are of concern, including:

• Less than 5% of adult cancer patients participate in oncology trials
• Fewer than 1 in 20 Americans know where to find relevant information on trials
• 80% of clinical trials fail to meet their enrollment timeline

These circumstances are further exacerbated by significant challenges in patient recruitment and retention, where the cost has continued to rise, and is estimated to consume between 30%-35% of clinical trial budgets, especially at phases II and III. On a blockchain, a clinical trial researcher or investigator could search candidates based on specific genetic, therapeutic, demographic, and geographic criteria without even knowing the patient’s name. In effect, blockchain can transform the patient engagement model by empowering patients to manage their complete electronic health record and giving consent to be searched for trial participation.

Transforming medical records into a node on the blockchain allows individuals to grant permissions to share what data they want and when, and consenting to be “searchable” from any researcher in the world while retaining anonymity. This allows clinical researchers to evaluate qualified candidates for a study, and data from a clinical trial participant would be appended to the blockchain record in real-time, thus allowing permissioned network physicians ready access. When fully leveraged, blockchain can close the disconnect between clinical and medical research while empowering a patient full governance of their individual medical records.

Enabling Blockchain: Overcoming Challenges

Emerging technologies naturally come with the art of the unknown. They have not been fully tried and tested; however, they hold promise to bring measurable benefits to humanity. Regarding blockchain, many have argued that the technology works and it is ready to be used in a variety of applications. That said, there are challenges directly related to clinical trials, although not necessarily technology concerns with blockchain adoption, but rather more to do with the processes, protocols and, potentially, policies that would need to change to make blockchain work the way it should. Some primary concerns are:

• In a patient-data driven blockchain model, who owns the data and who will/should pay to develop that blockchain?
• How do we validate the data inputs coming into the blockchain?
• What is the patient’s incentive for collecting/managing their own health record?
• How will e-consent function with blockchain and smart contracts?
• How will blockchain comply with GDPR, FDA, and other regulatory agencies as it relates to patient privacy?
• And, there is plenty of more

Building Consensus on Blockchain for Clinical Trials

The IEEE Standards Association (IEEE SA) will be hosting the Blockchain for Clinical Trials Forum on 12 February 2018 in Orlando, FL. This is one-day forum will discuss the applications for blockchain in clinical trials/research, the status of current pilot studies, different cutting-edge approaches, and a full hands-on attendee-driven discussion on how to resolve critical challenges to accelerate industry-wide adoption of the technology. Register today.