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Decentralized Clinical Trials: How Connected Health Helps Ensure Patient Safety

4 minute read

According to ClinicalTrials.gov, there are currently more than 360,000 registered studies taking place in all 50 U.S. states and 219 countries. Historical data from the site shows that this number has been steadily rising since it was first made publicly available in the year 2000.

The increasing need to develop therapeutics for chronic diseases, as well as the demand for COVID-19 treatment and vaccines, is driving the continued growth of clinical trials. The clinical trials market is expected to grow at a compound annual growth rate (CAGR) of 5.7% from 2021 to 2028, to ultimately reach an expected $69.5 billion, according to a report from Grand View Research.

Impact of COVID-19 on Clinical Trials

With the increased awareness of health threats — viral pathogens in particular — amid the COVID-19 pandemic, patient safety has been brought to the forefront of clinical trial operations. According to an article in the U.S. National Library of Medicine, the COVID-19 pandemic has created innumerable challenges for clinical trials, including reducing the risk of spreading the virus, staff shortages, travel restrictions, supply chain interruptions, equipment shortages, funding uncertainty, and more.

Over 1,000 clinical trials were suspended in March and April 2020 due to the global pandemic. The primary consideration on whether to suspend or continue a clinical trial is the safety of trial participants, per guidance issued by the U.S. Food and Drug Administration (FDA). Patient safety takes such priority in clinical trial operations that the FDA even suggests that trial sponsors should evaluate alternative methods, many of which are incorporated in decentralized clinical trials.  

How Connected Health Helps Ensure Patient Safety

Connected health refers to a model of healthcare management that utilizes technology for remote delivery of services, such as remote monitoring, data collection, telehealth, and more. Connected health devices are used to collect patient data, including biometric screenings through connected medical devices and patient-provided data through electronic diary methods such as eCOA and ePRO.

Connected health technology helps keep trial participants safe in several ways. By using telemedicine appointments instead of in-person clinic visits, patients reduce their risk of potential virus exposure. Remote patient monitoring tools help trial participants better manage chronic conditions and be proactive in their treatments. Electronic methods of patient data collection, such as eCOA and ePRO, provide improved data accuracy for better patient care and a simplified experience.

How to Decentralize Clinical Trials

While there are many benefits of connected health for decentralized clinical trials, especially when it comes to patient safety, it takes a significant amount of expertise and experience in the Internet of Things (IoT) to ensure a smooth deployment. IoT managed services providers like KORE handle the complexities of connected health for decentralized clinical trials so that life sciences companies can focus on cutting-edge clinical research.

KORE powers connected health devices with a combination of wireless connectivity and network management, mobile device management, and deployment services, reducing time-to-market and total cost of ownership for life sciences companies running decentralized clinical trials.

Are you ready to decentralize your clinical trials? This Decentralized Clinical Trials Readiness Assessment can help you determine if a traditional clinical trials model, hybrid approach, or fully virtual clinical trials model is right for you.

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