The global COVID-19 pandemic undoubtedly has far-reaching implications. As the world adapts to new ways of doing business, contract research organizations (CROs) and trial sponsors must adapt their clinical trial operations as well. Adopting Internet of Things (IoT) technology for connected clinical trials can improve patient retention and recruitment, enhance the patient experience, achieve more accurate continuous monitoring, and reduce time to market for vital medical products. These outcomes are paramount to maintaining trial integrity during a public health crisis.
New FDA Guidance
In response to the novel coronavirus (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) issued new guidance for conducting clinical trials. The purpose of the FDA’s new guidance is to address the challenges that may arise from quarantines, site closures, travel restrictions, supply chain interruptions, and disease infections. These challenges must be addressed while assuring the safety of trial participants, maintaining compliance, and minimizing risk to trial integrity.
According to the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, issued in March 2020, “since trial participants may not be able to come to the investigational site for protocol-specified visits, sponsors should evaluate whether alternative methods for safety assessments could be implemented when necessary and feasible.” Such alternative methods include virtual visits, remote monitoring, and the use of electronic data sources.
Remote Monitoring of Trial Participants
Reduced site visits for trial participants due to COVID-19 shouldn’t negatively impact a clinical trial. In fact, remote patient monitoring and the use of ePRO/eDiary software, delivered through mobile devices, can improve the patient experience while reducing or eliminating the need to visit physical clinical sites. And because IoT technology and mobile devices provide patients with constant insight into their health, many feel more at ease when entering into early phase clinical trials.
The use of IoT technology for remote monitoring is supported by the FDA’s new guidance, which states “If planned on-site monitoring visits are no longer possible, sponsors should consider optimizing use of central and remote monitoring programs to maintain oversight of clinical sites.” IoT technology for remote monitoring can enable timely intervention and diagnosis, improved accuracy, proactive treatments, and better treatment outcomes. This level of monitoring can ensure the safety of trial participants, which according to the FDA is “paramount.”
Better Data and Faster Time to Market
Clinical trials depend on accurate, consistent data collection. The use of mobile devices, tablets, smartphones, wearables, and IoT technology can reduce errors associated with human data collection and provide medical-grade biometrics. 35.2% of respondents in a survey by Applied Clinical Trials answered that improvement in data quality was the biggest benefit of mobile devices and mHealth technology in clinical trials.
In clinical trials, patient engagement, retention, and data quality all play a role in reducing time to market. By delivering more accurate and timely clinical trial data, IoT technology accelerates the decision-making process, allowing sponsors to get their product to market faster. This is especially critical when developing necessary medical products during a public health emergency, such as the current COVID-19 outbreak.
Streamlining the Process of Connecting and Managing Devices
If not executed properly, the adoption of IoT technology in clinical trials can bring significant unexpected costs. Up to 50% of these costs can come from network communications, such as monthly wireless access fees which can be exacerbated by monthly data overages. To address these and other hidden challenges in IoT deployments, trial sponsors and CROs are embracing third-party service providers to manage the complexities and streamline operations.
KORE works with several leading CROs and pharmaceutical companies to streamline the process of sourcing, securing, and connecting mobile devices that are used for patient data collection within clinical trials across the globe. This is done through a suite of managed services that includes mobile device management (MDM), wireless connectivity, deployment and logistics, and project management.
Improved patient care, accurate and timely data, and speed-to-market for clinical trials are more important than ever. As COVID-19 changes the way trial participants are monitored and data is collected, connected devices and IoT technology enable sponsors and CROs to comply with new FDA guidance while reducing time-to-market.
Learn more about how IoT managed services from KORE Life Sciences can help reduce the overall cost of ownership for connected clinical trial deployments while lowering risk and improving efficiencies.
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