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December 20, 2021updated 07 Jan 2022 6:46am

Virtual Clinical Trials: Technology Trends

Fully virtual or decentralised trials involve all elements of the trial being conducted remotely and using technologies and processes such as eConsent, telemedicine, electronic clinical outcome assessment (eCOA), remote patient monitoring (RPM), mobile health (mHealth), wearables, and digital biomarker collection.

By GlobalData Thematic Research

Virtual trials help in reducing patient burden, increase patient satisfaction, and improve retention rates.

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Listed below are the key technology trends impacting the virtual clinical trials theme, as identified by GlobalData.

Wearable technology

Significant developments have occurred in wearable devices and sensors that continuously monitor and collect patient data in a convenient and non-invasive manner. Trial participants can use smartwatches, skin patches, and even smart clothing to monitor measurements such as heart rate, blood pressure, oxygen saturation, respiratory rate, electrocardiogram (ECG), and glucose levels, as well as movement-based metrics such as tremor, gait, and seizures.

wearable devices can be paired with virtual trial platforms or other eClinical software to track and store patient data, which can be then be reviewed and analysed by research staff and investigators. Many companies are offering traditional research-grade wearable devices for use in clinical trials, such as ActiGraph.

mHealth

Wearable devices, smartphones, tablets, and mobile apps form a core part of virtual trial technology. Apps are used throughout the virtual trial value chain, such as patient recruitment and enrolment, eConsent, collection of eCOA and data from connected devices, patient communication and engagement, micro-reimbursements, facilitating telehealth visits with investigators.

Most players in the virtual trials space provide their patient-facing services on customisable and compliant app-based platforms for their clients, ensuring that the patient experience is convenient, seamless, and secure. Patients can also use their own smartphone or tablet to download and use these apps.

Telemedicine

Telemedicine became an invaluable tool during the Covid-19 pandemic, allowing patients to connect with and receive care from providers while maintaining safety and minimising risk of transmission. Telemedicine companies reported unprecedented demand for their services and with some temporary reimbursement policy changes becoming permanent, telemedicine will likely find a lasting place in the delivery of care post-pandemic.

Technology and connectivity disparities

A key requirement for the successful implementation of virtual trials is the availability of a smartphone or tablet and broadband internet connectivity. A major challenge for many populations such as the elderly, rural communities, or low socioeconomic populations is a lack of equipment, infrastructure, and adequate internet connectivity. Many people who cannot afford extra minutes on wireless plans, or simply do not have access to smartphones, may therefore not be able to participate in virtual trials. Governments will need to ensure that investments are made in infrastructure to prevent a digital divide in clinical research.

Cloud computing

The use of cloud-based virtual trial platforms allows for the robust and secure collection and synchronisation of vast amounts of data from multiple disparate sources, interoperability between different eClinical software systems, secure single access for study teams, and support for advanced analytics and insight generation.

Cloud computing allows for the rapid scale-up of trials to serve a large number of patients and the use of multiple languages to deploy trials across geographies. Cloud-based systems also support personalised patient engagement and communication and give trial participants a seamless and interactive user experience.

5G

5G networks have the potential to improve all critical components of virtual clinical trials. The speed of these networks can help patients living in rural or remote areas to participate in trials, enhance telemedicine capabilities, and allow the capture and transfer of large, high-quality images or files from patients, home healthcare companies, laboratories, and other diagnostic providers.

5G networks will also allow for the use of more connected devices in trials, with an enhanced collection of data from wearables and other sensor-based devices. Data capture is also more reliable when conducted with high-speed networks.

Artificial intelligence (AI)

AI and its application in data analytics have the potential to enhance many aspects of the virtual trial value chain. It can be used to enhance clinical trial design, identify hypotheses, and minimise potential risks. Machine learning (ML) and natural language processing can be used in participant recruitment by using electronic health records (EHRs) and data from connected devices to match patients with trials and then recommend these trials to the patient or their physician.

AI allows the large-scale mining and advanced analysis of the vast amount of data generated from many different digital sources in virtual trials to identify trends, flag issues, and enhance interpretations of trial findings. AI, for example, can support patient retention by tracking non-adherence to the investigational drug, notifying research staff of any deviations, and allowing staff to take timely preventative measures.

Blockchain

Blockchain has the potential to enhance virtual clinical trials in several ways, including increased transparency, allowing the traceability of informed consent, and improving the quality and reliability of clinical trial data. Some common challenges of virtual trials include data reliability and integrity issues, low compliance, data security and privacy issues, and poor informed consent management. Blockchain technology can act as central data storage for virtual clinical trials and provide the data integrity, data security, and data privacy that is required by regulatory agencies.

Common problems with informed consent include failure to obtain written informed consent, unapproved forms, invalid consent documents, and failure to re-consent after protocol changes. Blockchain provides a means of time-stamping consent forms that cannot be tampered with. It also enables storing and tracking the consent in a secure and verifiable way, and enabling the sharing of information across different sites in real-time.

Cybersecurity

The healthcare industry is a key target of malicious cyber threat actors due to the vast amount of valuable and sensitive data it holds. The digitisation of the healthcare industry is providing more avenues for cybercriminals to steal personal and proprietary data, including from medical health records and connected medical devices. Connected devices that collect personal health data, such as wearables, frequently exchange data with paired devices via Bluetooth, which makes them especially susceptible to hacking.

This is an edited extract from the Virtual Clinical Trials – Thematic Research report produced by GlobalData Thematic Research.

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