Revolutionizing Clinical Trials with the IoT and Blockchain Technology
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CBDS Health is a health technology company focused on revolutionizing the clinical trials space through the deployment of information technologies including the internet of things (IoT), big data analytics and blockchain.
The Company’s virtual clinical trials platform is a cost-effective solution for researchers and contract research organizations (CROs). CBDS Health is currently enhancing this platform by incorporating blockchain for the onboarding and tracking of patient information pertinent to clinical trials and health monitoring.
The CBDS Health Clinical Trials platform, was developed by ORCATECH, which is an academic sister organization originated at the Oregon Health and Sciences University (OHSU). The Company acquired the IP for the virtual clinical trials platform from OHSU. The platform incorporates state-of-the-art monitoring sensors and wearable technology in the home to track patient data in real-time and real-world scenarios. To date, the platform has been used in over 60 studies with over 1,000 participants and has captured over 1 million hours of continuous home monitoring data. All this information has resulted in over 130 peer reviewed publications.
CBDS Health’s mandate is to improve the platform by incorporating blockchain to effectively and securely track, store and share patient information in clinical trials. This added layer will enhance the clinical trial process as it provides solutions linked to patient onboarding and retention, improved data accuracy, security and regulatory compliance, all of which mitigate reputational and financial risks for trial sponsors.
ORCATECH has been supported by multiple collaborators that include Pfizer, General Electric, Microsoft, Phillips, Intel, Vtech, Sony, Novartis and Lilly. With the support of these partners and a group of research collaborators led by OHSU, CBDS Health aims to target the clinical trials market associated with Alzheimer’s, Parkinson’s, mild cognitive impairment and pain management. Currently developing the additional layer to their platform, the company expects to see revenue from clinical trials in Q3 of 2018.
CBDS Health is led by a management team with valuable experience in both the health science, IoT and network development spaces. The management team is also significantly invested in the company as primary stakeholders.
- Building blockchain into applications within the existing virtual clinical trials platform
- Enhancing the platform security, transparency, data accuracy and data sharing
- Platform delivery via cloud deployment to client entities like CROs for clinical trials
- Targeting initial clinical trials in Alzheimer’s, Parkinson’s, mild cognitive impairment and pain management
- Experienced team of health science and network development specialists
Clinical Trials on Blockchain
Enabling clinical trials with the Internet of Things (IoT)
Healthcare systems maintain significant amounts of patient information that needs to be collected, shared, analyzed and stored. With the development of digital tools and the internet, this information has transitioned from being managed manually and on paper, to being incorporated into digital systems. Following this trend, components of the IoT—interconnected devices/sensors that can be used to passively or actively gather and analyze real-time data—have been deployed to play a role in patient monitoring. Similarly, the IoT is also proving applicable to clinical trials as it provides real-time health and behavioral information of test subjects in real-world environments.
According to MarketResearch.com, the IoT market in healthcare will be worth $117 billion by 2020, with a cumulative annual growth rate of over 30 percent. Contributing to this market, CBDS Health has the world’s first virtual clinical trial platform developed by ORCATECH, a sister organization developing and implementing clinical research technologies at the Oregon Health and Sciences University (OHSU).
CBDS Health’s cloud-based IoT platform uses state-of-the-art sensors, wearables, surveys and other tools to detect digital biomarkers—human physiological and behavioral measures—and collect and analyze real-time and historical patient data associated with cognition, physical function, behavior, genetics and others. As such, the company’s pervasive computing solution continually monitors multiple symptoms, tracks medication intake and uses self-report surveys to collect critical information, continually providing data from over 200 patient homes. This approach has already turned the clinical trial process on its head, reducing paperwork, increasing real-world and real-time tracking that can be done outside of a clinical setting, and making data analysis much more efficient.
Using their experience in developing robust data collection and analysis systems within an IoT framework, CBDS Health is now enhancing the cloud platform by incorporating blockchain.
Adding blockchain to the equation
Originally launched as an underlying structure to digital currency, blockchain is a permanent, real-time ledger tracking and storing information regarding transactions. At any point in time, those transactions can be seen by anyone in the network, making it a transparent system. Applicable beyond digital currencies, blockchain can also be used to transfer information between multiple parties in a secure fashion, and it is in this manner that it can play a transformative role in the realm of clinical trials.
Introducing blockchain into its virtual clinical trial platform, CBDS Health will use the blockchain ledger to store, review and transfer patient information (e.g. passively captured data, survey answers, video or phone chats, patient registration). In this manner, the company is addressing some of the most pertinent obstacles to effectively completing clinical trials such as reproducibility, patient attrition, data sharing and lack of collaboration between various parties contributing to the trial. As the industry faces pressure to improve patient retention while managing the ever-increasing cost to do so, incorporating blockchain into clinical trials introduces new solutions and efficiencies to the sector.
Ensuring validity of collected data
One of the most pertinent issues facing clinical trials is the reproducibility of their data. Up to 70 percent of trials are not reproducible, and that is often linked to the fact that patient data cannot be validated , something that is solved by CBDS Health’s platform. On some occasions, the lack of reproducibility is a result of fraudulent data that has been fabricated or changed to help meet the goals of the trial. This brings additional costs—both monetary and reputational—to trial sponsors as they have to repeat certain aspects of the study and suffer from negative perceptions. Using better on-boarding and validation technologies combined with blockchain addresses this issue by improving the accuracy and the accountability of data collection through the implementation of permanent and auditable records that, for instance, include timestamps or other identifying indicators.
Addressing patient attrition
Another significant problem in the clinical trial space is patient attrition. According to a 2015 analysis of patient attrition, on average, 30 percent of patients in a clinical trial will drop out before finalizing the trial. As such, 85 percent of trials fail to complete due to patient dropouts. By increasing the security and validity of information, as well as reducing the amount of testing patients may have to undergo, CBDS Health anticipates that patient retention will increase. More stable patient retention rates in the industry will reduce the costs associated with attracting and retaining patients.
Improved trust between clinical trial stakeholders
In many cases, trials are conducted by a varied combination of researchers and CROs and these parties tend to be unwilling to be monitored by or share information with the other stakeholders in the trial. Blockchain addresses this barrier to collaboration by making all the information related to the trial available to the relevant stakeholders without risk and also allows for non-intrusive monitoring of the data and associated analyses as this data is captured by the different monitoring tools.
Streamlining regulatory reviews
The real-time availability of data also streamlines the monitoring done for regulatory purposes. Currently, regulatory reviews are conducted after studies have been performed, with issues only arising at a point where solving them would require repeating a portion of the study. Now, with the use of blockchain, regulatory reviews can be performed proactively, catching errors or concerns early on, thus reducing associated costs and improving the trial’s chances of success. Additionally, trial sponsors can ensure that their project is compliant throughout the entirety of the process.
Brian Leeners, BComm, LLB—CEO
Brian Leeners received both his BComm and LLB degrees from the University of British Columbia in 1992 and since that time has been focused on the management of private to public venture companies. In 1997, he joined his first public company where he became President and CEO in 1999. In 2002, he founded Nexvu Capital Corp, which is a venture capital firm focused on developing companies in the Resource and Technology Sectors. He was a founding board member of DigiBC and a former member of the Funding Review Committee in Computers and Computing for the Science Council of British Columbia as well a former member of the Business Advisory Board of the BC Advanced Systems Institute.
Jeffrey Kaye, MD—Chief Medical Advisor
Dr Jeffrey Kaye is the Layton Endowed Professor of Neurology and Biomedical Engineering at Oregon Health & Science University. He is the director of ORCATECH and director of the NIA – Layton Aging and Alzheimer’s Disease Center. His research has focused over the past two decades on understanding healthy aging using a variety of approaches ranging across the fields of genetics, neuroimaging, physiology and continuous activity monitoring. He leads several longitudinal studies of aging including the ongoing Oregon Brain Aging Study, the Intelligent Systems for Detection of Aging Changes (ISAAC) study and the ORCATECH Living Laboratory. The latter studies use pervasive remote sensing and computing technologies for continuous assessment of health and function among older adults in their homes.
He has received the Charles Dolan Hatfield Research Award for his work. He is listed in Best Doctors in America. He serves on many national and international panels and review boards in the fields of geriatrics, neurology and technology including as a commissioner for the Center for Aging Services and Technology (CAST), Chair of the International Society to Advance Alzheimer’s Research and Treatment (ISTAART), a member of the Advisory Board of AgeTech West, and on the Leadership Council of the Network on Environment, Services and Technologies for the American Society on Aging. He is an author of over 300 scientific publications and holds several major grant awards from federal agencies, national foundations and industrial sponsors.
Judith Kornfeld, MBA—COO
Judith Kornfield is the Chief Business and Operations Officer of ORCATECH. Through building worldwide strategic collaborations and alliances while positioning Intellectual Property assets and leveraging products in development, she specializes in bringing innovative medical technologies to prosper in the medical industry. Prior to joining ORCATECH she assumed executive business development positions of emerging medical technological companies in the specialty pharmaceuticals and medical device industries. Recently, she held the position VP of Business Development of TransPharma Medical, a company focused on developing pharmaceutical products based on breakthrough proprietary transdermal drug-delivery technology. She holds a bachelor’s degree in life sciences and an MBA, as well as an academic background in electrical engineering.
Daniel Starbuck—Chief Technology Officer
Daniel Starbuck has over a decade of experience building scalable enterprise business applications for a wide variety of clients, from large Fortune 500 companies to startups. He has extensive experience in the fundamentals of Blockchain. His knowledge and experience are the key drivers to designing and building the secure platform. His role and responsibilities include but are not limited to application architecture, project and staff management, idea and feature development and business strategy integration.
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