According to the FDA, decentralized clinical trials (DCTs) are defined by “the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data.” What the FDA means is they are when all activities take place outside “traditional” trial sites. This is through telemedicine healthcare providers. DCTs 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 and solutions 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.
In a centralized trial, data is manually collected during the in-person appointment at a single point in time; however in a DCT, large amounts of data are collected at multiple points in time, revealing previously unknown relationships in data.
Benefits of Decentralized Clinical Trials:
The main potential negative of a DCT is that patients may need access to these resources, which can limit the information that can be collected.
In a DCT, some or all of a clinical trial's activities occur at locations other than a traditional clinical trial site. These alternate locations can include the participant's home, a local health care facility, or a nearby laboratory. 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.
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 DCTs, devices may be provided to the patients by their care providers or clinical staff. IoT managed services providers like us at KORE help companies deploy connected health solutions with a suite of services that includes hardware procurement, configuration, kitting, shipping, reverse logistics, and warehousing.
One solution that is used is Comprehensive Mobile Device Management (MDM); they are specifically 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 DCTs. This is done through a suite of managed services that includes 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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