Blockchain is the buzzword in healthcare IT.

But what is it about blockchain that makes it so valuable for clinical research?

Currently, most medical records are scattered across several data silos, with healthcare providers having access to data on their networks, and patients having incomplete access to their own records and medical history. Gathering a patient’s full information is costly and time consuming. Besides being expensive to compile and maintain, centralizing medical records makes them vulnerable to security breaches. Today, patients themselves are best positioned to access and aggregate their clinical and genetic data because only they have a complete picture of where they have received care or with which labs they have interacted for medical testing. Mobile applications are available today that allow individuals to aggregate, organize, and share their medical records from wearables, Electronic Health Records Systems (EHRs), and medical labs. When these mobile applications are coupled with blockchain, they provide a tamper-resistant means of sharing each patient’s complete medical history, with immutable smart contracts, and digital time stamping with trusted sources.

The IEEE Standard Association recently held a forum on Blockchain for Clinical Trials to launch an industry collaborative of interested parties (pharma, startups, government, patient advocacy 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 for industry-wide adoption (from IEEE website). 

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

This forum represented the first step for IEEE in bringing this 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 test-beds or process and policy guidelines to drive adoption of blockchain applications in clinical trials.

Also at the conference it was revealed that government regulatory agencies like the FDA are paying close attention to blockchain; certainly a welcome and positive step. E-contracting and e-consents are promising future developments if the clinical research community and the regulatory bodies adopt them.

Finally, is there really a use case for a virtual clinical trial in the digital world without actual research sites and physical clinics. 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 multiple visits to a physical site. Health Wizz has developed the platform and tools that allow to plan and execute virtual clinical studies. 

Future clinical trials will definitely embrace the use of technology to allow patients to participate remotely, with the balance between virtual and in-person visits varying according to the needs of the study. And as an incentive for sharing digital records or participating in the trial, blockchain allows for use of a digital currency as a reward for participation. So it is conceivable that with wearable devices and with FDA approval, the internet of things of biological data will reach into the world of digital health care. 

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 are well known. Creating longitudinal lifetime medical records starting with Genomic data, clinical data end points and their validation, and verifying data being trustworthy are current challenges for clinical research. Looks like we are on to some great use cases with the buzz around blockchain in health care! If you are ready to address these challenges click here.