Blockchain is the buzzword in healthcare IT. But what is it about blockchain that makes it so valuable for clinical research?

Currently, most electronic health records (EHRs) are scattered across several data silos, with healthcare providers only having access to data on their specific network. This means that patients don’t have access to their own records and medical history. In fact, essentially nobody has their complete longitudinal health data on hand.

That’s a problem in clinical research, because gathering patients’ full medical information is costly and time consuming, and centralizing medical records makes data vulnerable to security breaches. Additionally, it is the patient who is best positioned to access and aggregate his or her clinical and genetic data, because only they have a complete picture of where they have received care or which labs they used for medical testing.

Mobile applications are available that enable individuals to aggregate, organize and share their medical records from wearables, EHRs , physicians, medical labs and other sources. However, when these mobile applications are coupled with blockchain, they provide a tamper-resistant means of compiling and sharing each patient’s complete medical history, with immutable smart contracts that govern when and how data is shared, and digital time stamping of when the data was added or altered.

The IEEE Standard Association recently held a forum on Blockchain for Clinical Trials that gathered the industry’s major stakeholders (pharmaceutical companies, startups, government representatives, patient advocacy groups and academia). The focus was on developing technical standards and guidelines for the use of viable blockchain applications that will create a more inclusive patient recruitment program, restore data integrity and innovate drug development.

The forum identified use cases for blockchain application in clinical trials as well as barriers and challenges to be resolved before industry-wide adoption can take place.

During the discussion, the following important points were addressed:

  • Determining how blockchain can connect the data generated from medical care back to clinical research.
  • Using blockchain to ensure data integrity and retain patient privacy.
  • Recognizing how technical standards will accelerate adoption.
  • Understanding the patient perspective, including incentives, concerns and compliance.
  • Recognizing the benefits and challenges of public vs. private blockchain applications.
  • Understanding the legal and technical side of smart contracts for e-consent.

This forum represented the first step in the IEEE’s program for bringing this important industry initiative to fruition. Next steps include publishing an industry report derived from the forum discussions to provide viable use cases and associated challenges for blockchain in clinical trials, and recruiting working groups to develop frameworks for creating testbeds or process and policy guidelines to driving adoption of blockchain applications in clinical trials.

The conference revealed that government regulatory agencies like the Food and Drug Administration (FDA) are paying attention to blockchain, which is a positive step. E-contracting and e-consents are promising future developments if the clinical research community and regulatory bodies accept them.

Finally, is there really a use case for a virtual clinical trial in the digital world without actual research sites, CROs, physical clinics and the like? Only time will tell if this model will fit in the clinical trial world or whether a hybrid model will gain sufficient momentum to eliminate the need for reporting to a physical site.

There are already new innovative technological solutions and tools that enable organizations to plan and execute clinical studies. Future clinical trials would embrace the use of technology to enable patients to participate remotely, with the balance between virtual and in-person settings varying according to the needs of the study.

And as an incentive for sharing digital records or participating in the trial, blockchain enables the use of a digital currency as a reward. So it is conceivable that with wearable devices—some with FDA approval—the Internet of things of biological data will reach into the world of digital healthcare.

Blockchain has a definitive presence in healthcare IT, and clinical research and is a great fit for several use cases. The challenges of patient recruitment and engagement, longitudinal lifetime medical records starting with genomic data, clinical data end points and their validation, and verification of data are current challenges for clinical research.

From these developments, it looks like the industry is on the way to developing some great use cases and exciting new developments as blockchain gains adoption in healthcare.

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