Decentralized clinical trials (DCT) attempt to reduce or eliminate study site visits for patients, thereby easing participation and improving patient retention. This is accomplished through the use of Internet of Things (IoT) technology such as smartphones or tablets for patient data collection, medical sensor or wearable devices, and cellular connectivity for secure data transmission.
According to Applied Clinical Trials, drug-based interventional DCTs only experienced a 7% CAGR between 2014 and 2019, and that rate jumped to 77% between the second halves of 2019 and 2020, following the onset of the pandemic.
The most common connected health devices used in DCTs fall into two primary categories: consumer-grade health monitoring devices and medical-grade wearable technology. These devices are equipped with sensors and connectivity to take biometric readings and transmit those readings to cloud-based platforms and APIs where they can be viewed and analyzed by healthcare providers and researchers.
Medical devices may be used to collect patient data remotely, and connectivity is needed to transmit that data to the cloud so that it can be accessed by healthcare providers and clinical staff. Some devices may be equipped with embedded cellular connectivity, while others — like Bluetooth-enabled medical sensors — may rely on a hub for cellular connectivity, such as a smartphone, tablet, or another connected device.
In some decentralized clinical trials, devices may be provided to the patients by their care providers or clinical staff. IoT managed services providers help companies deploy connected health solutions with a suite of services that includes hardware procurement, configuration, kitting, shipping, reverse logistics, and warehousing.
Comprehensive Mobile Device Management (MDM) 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 that result in lower risk, reduced costs, and improved efficiency in the operation and execution of clinical trials.
IoT enablers help companies cut through the complexities and reduce risk, but it’s important to select a partner who understands the unique requirements of life sciences, pharmaceutical, and clinical research companies across the globe. Regulatory compliance, technical ability, ecosystem, and logistics are exceptionally important to consider when looking to decentralize clinical trials.
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. This is done through a suite of managed services that includes mobile device management (MDM), wireless connectivity, deployment and logistics, and project management — all provided from FDA registered and ISO 9001/13485 certified facilities.
Download the eBook, “Roadmap to Decentralized Clinical Trials” to learn more about the Connected Health technology used in decentralized clinical trials.
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