By Raphael Yaakov and Ozgur Guler,PhD
February 15, 2021
Blockchain technology has boldly entered the clinical research realm with the promise to change the industry in ways we cannot yet begin to fathom. We witnessed the rise of Bitcoin, a cryptocurrency that makes it possible for people to transfer funds between one another without going through a bank or clearinghouse. This disruption moved finance functions from a centralized to a decentralized point of authority, significantly reducing operation costs, enabling real-time transactions between institutions, and reducing the risk of hackers or bad actors capturing transaction information or diverting payments.
The disruption in clinical research is imminent. The COVID-19 pandemic pushed us closer to the precipice of a digital revolution. We have seen an increase in adoption of telehealth modalities like wearable and connected devices. An interest in decentralized or virtual trials intensified across different therapeutic areas offering a unique opportunity to reach a diverse pool of participants, improve compliance and retention, and to shorten the clinical trial cycle (Read more on vRCT). In wound care, there was an increased uptake of telehealth and remote patient monitoring modalities (to learn more on telehealth, click here). The challenge that curtailed enthusiasm was the growing concern around data privacy and security. This is where the value of blockchain begins to unravel.
Blockchain, reduced to simplest terms, is a growing list of records which are bundled together into blocks linked using cryptography. The record is checked and verified by nodes, which are connected to each other and constantly exchange the latest data. The accepted records are added to a block which contains a unique code referred to as cryptographic hash or hash codes. Hash codes connect blocks together in a specific order and generate a unique string of letters and numbers that makes data secure. A change or modification to the data would generate a new hash, which would break the chain and reveal the intrusion. With this technology, medical history and other records can be securely stored. Contrary to digital currency, which uses permissionless blockchain internal data storage application can be permissioned blockchain. Permissioned blockchains are private blockchains that have clearly defined governance and can only be accessed by credentialed users. By design, a blockchain is resistant to modification of its data.
Blockchain can create an audit trail for regulators that is easy to decipher and validate. As new data is entered or changed, hashes accumulate sequentially, creating a digital signature for the block of data. If patient-reported data is changed or erased, by a research site user for example, the user’s changes are appended to the original data. This increases transparency and visibility of any potential data corruptions. Beyond enabling security and privacy, blockchain puts patients at the center of care. Patients can aggregate their own health data, which until recently has been disjointed because of the lack of interoperability between various electronic medical records, across different providers and institutions.
A distributed ledger of blockchain hashes can be maintained for all collaborating parties. Another benefit would be real-time reporting of adverse events, which can boost the safety and efficiency of clinical trials. Blockchain can enable smart contracts where a serious adverse event would generate a code which can be reported directly to investigators and regulators, increasing transparency and accountability.
Blockchain technology has a wide range of applications. It can also drastically transform clinical supply chain. Where current processes are fragmented due to data silos, blockchain can give greater visibility across all supply chain activities. Convergence with internet of things (IoT) and artificial intelligence (AI) will create new opportunities. Amazon’s Quantum Ledger Database (QLDB) is an interesting example of a serverless platform that can enable real-time flow of data, workflow and analytics. Since there are no servers to manage and no read or write limits to configure, it can easily be scaled to support demands of an application. This technology holds great promise for a broad range of applications across healthcare and life sciences, presenting a path forward for precision medicine and improving outcomes.
The views and opinions expressed here are those of the authors and do not necessarily reflect the official policy or position of any other agency, organization, employer, or company.
Raphael’s experience spans across public health, clinical research, and technology. He has helped support key initiatives in patient education programs, global epidemiological surveillance to managing phase I-IV multinational drug and device studies. He completed his undergraduate course work in life sciences at the Pennsylvania State University and holds a MS with a concentration in pharmacoeconomics and outcomes research from University of the Sciences in Philadelphia. He currently serves as the VP of Clinical Development at eKare Inc.
Özgür Güler is an imaging scientist specializing in 3D wound imaging and computer vision. Prior to eKare, he was a researcher at the Sheikh Zayed Institute (SZI) for Pediatric Surgical Innovation in Washington DC, where he developed the segmentation and classification algorithms that laid the groundwork of the eKare inSight system. Dr. Güler received his PhD from the Medical University Innsbruck in Austria with focus on image‐guided diagnosis and therapy, MS in Computer Science with focus on image‐guided surgery and BS in Computer Science from Leopold‐Franzens University Innsbruck.