While the connected health technology needed to support decentralized clinical trials (DCT) has been available for quite some time, it’s still largely underutilized in clinical research as well as the broader healthcare community. According to a 2020 survey of clinical trial professionals by Informa Connect, decentralized and virtual trials still represent less than half of clinical research, with roughly one-quarter of ongoing trials incorporating DCT components.
Even though DCT represents a small but growing percentage of clinical trials, the benefits of decentralized trials are well documented. Hybrid and virtual clinical trials that rely on mobile devices result in enhanced data collection, improved patient experience, and accelerated time to market.
The traditional approach to clinical trials, which requires in-person visits at physical sites for recruitment, screening, treatment, and follow-up, and relies on paper diaries for the manual recording and transfer of patient data, is experiencing rising costs and increased safety concerns in the era of COVID-19 and beyond. These are issues that can be addressed — and mostly solved — through the use of connected health devices and Internet of Things (IoT) technology.
The hybrid approach to clinical trials includes elements of both traditional and decentralized clinical trials. In this model, some visits may occur virtually while still offering some in-person visits to physical sites. A primary differentiator between hybrid and traditional clinical trials is in the use of connected mobile devices and wearable technology for data collection, such as smartphones, handheld mobile devices, and connected medical devices like blood pressure cuffs, blood glucose meters, pulse oximeters, and more.
The decentralized clinical trial (DCT) model, also sometimes known as virtual clinical trials, is one where all aspects of the trial are technology-based, including recruitment, prescreening, treatment, and follow-up. In fully virtual clinical trials, there is no human-to-patient interaction at all.
DCT and fully virtual clinical trials leverage much of the same technology as hybrid clinical trials, including electronic diaries for eCOA and ePRO, wearable technology, and connected medical devices such as Bluetooth weight scales, blood pressure cuffs, and pulse oximeters. In addition, they rely on patient recruitment and retention platforms, e-visits, and video dosing regimens.
KORE has a tailored suite of managed services designed to make developing and maintaining decentralized clinical trial solutions easier than ever, and includes end-to-end project management, consulting, and comprehensive Mobile Device Management (MDM). These solutions are specifically built to meet the unique patient privacy and security requirements of the life sciences industry.
Clinical trial companies can improve and enhance data collection with custom controls from KORE — resulting in lower risk, reduced costs, and improved efficiency in the operation and execution of hybrid and decentralized clinical trials. Use this decentralized clinical trials readiness assessment to determine if a traditional clinical trials model, hybrid approach, or fully decentralized clinical trials model is right for you.
To learn more about the hidden challenges of creating decentralized clinical trials, and how to overcome them to ensure accelerated returns to your organization, register for the free webinar “The Insider’s Guide to Successful Decentralized Clinical Trials.”