Blockchain Use in Research

Applied Clinical Trials

The core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data.

The core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data. The excitement around using blockchain technology in health care is also growing. Proponents point to blockchain’s potential to liberate data from entrenched silos, empowering patients to securely “own” their data. This is a shared source of truth and has the capability to transform the clinical research industry. And what drives this technology is the drive to revolutionize patient care.

In addition to increased costs, today’s researchers face the challenges of accurately reproducing data, efficiently sharing data (including personal data), privacy concerns, and patient enrollment strategies. This is where this level of “disruptive innovation” steps in and drives this technology forward. The best part about blockchain is that data stored in a blockchain is essentially impossible to hack, infringe, or steal, because the ledger is not kept on a single repository, but is spread throughout multiple databases in replicate copies. The advent of companies connecting their devices to mobile apps and the cloud will rightly necessitate greater consideration and discussion of cyber security risks. With enormous amounts of clinical trial data being generated every day, and pressures from commercial and regulatory agencies to overcome big data hurdles, it’s becoming obvious that legacy data management systems are not powerful enough to process and retain the data extracted from all the current research studies, posing problems for patient privacy, as well as data integrity.

A major win for using a blockchain the biopharma industry can be seen in how patient data is collected, stored and its accessibility. It is imperative for investigators to have the ability to locate individuals for studies. With current technologies, however, data is scattered across multiple proprietary systems that are often independent and incompatible with each other, making it extremely difficult to recruit individuals for trials.

A blockchain could also streamline the communication between doctors and patients during the trial. This kind of AI has the tools to provide smart contracts that endorse transparency and traceability over clinical trial sequences and can provide financial incentives for a patient’s participation and sharing of their data. This kind of organizational transparency and inclusivity can empower patients and doctors and improve the delivery of care.

Another benefit of utilizing this level of innovation would be the ability for patients to better connect with individuals who have similar conditions (e.g., in rare disease populations), which can enhance trial referral potential. We need to remember that patient engagement is a key driver for any research and so we need to ensure that patient’s can find information that is available and has real value.

There are some daunting facts relating to patient engagement in today’s clinical trials that are of concern. According to writers at Beyond Standards, some of these concern include:

· 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.

What is Needed to Employ This AI Ecosystem

1. Design Model and Roadmaps

- Need to demystify what blockchain is and its real value. Show industry doubters that this is not just a big hammer looking for a nail. Its real value could create greater data security and transparent governance models

- Help create mind maps for workflows and processes 

- Plans to establish trust among the various actors in clinical research is also essential, in the form of clinical research contracts, consents, and agreements.

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. Some areas that still need to be reviewed before this form of disruptive technology takes hold are:

· 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 digital signatures be employed? 

· How will blockchain comply with GDPR, FDA, and other regulatory agencies as it relates to patient privacy?

This new-age artificial intelligence is going to break ground in the biopharma industry, but when is truly yet to be seen. The industry is looking for the companies that want to be the leader of the pack and make a move on this new machine learning. However, in the immediate future, a more realistic goal might be to address issues around data integrity, reproducibility, and regulation, like GDPR transparency. While leaders in the industry try to adopt blockchain within the clinical research ecosystem, the most immediate need is arguably for resources to help them identify its intrinsic value. This level of innovation can be a win-win-win for investigators, pharma companies, and patients. 

 

Jeff Parke, Site Activation Coordinator, IQVIA