Virtual Clinical Trials – Thematic Research

Virtual Clinical Trials Market Overview

Virtual clinical trials, also commonly referred to as decentralized clinical trials (DCTs), use digital technologies and other processes that differ from traditional trial models to bring research closer to patient’s homes in order to increase access to trials, as well as reduce inconvenience and burden on participants by decreasing the number of physical site visits. Virtual trials are also known as remote, siteless, hybrid, or digital trials. The examples of digital technologies used in virtual trials includes eConsent, telemedicine, electronic clinical outcome assessment (eCOA), remote patient monitoring (RPM), mobile health (mHealth), wearables, and digital biomarker collection.

An increasing number of trials were using virtual components before the COVID-19 pandemic. COVID-19 lockdowns and social distancing measures caused significant disruption to clinical trials and accelerated the use of virtual trials. Companies that had not considered this model before had no option but to rapidly implement new technologies and procedures to maintain business continuity. Research shows that many companies will continue to use virtual trials after the pandemic. Over the past 18 months, many leading clinical research organizations (CROs) and eClinical software providers have expanded their capabilities in response to the growing demand for these services. Several specialist virtual trial providers have also emerged in recent years and attracted considerable attention during the pandemic.

What are the key technology trends in the virtual clinical trials MARKET?

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, ECG, and glucose levels, as well as movement-based metrics such as tremor, gait, and seizures. These devices can be paired with virtual trial platforms or other eClinical software to track and store patient data, which can then be reviewed and analyzed by research staff and investigators.

mHealth: Wearable devices, smartphones, tablets, and mobile apps are form a core part of virtual trial technology. Apps are used throughout the virtual trial value chain, such as for 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 customizable and compliant app-based platforms for their clients, ensuring that the patient experience is convenient, seamless, and secure.

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 minimizing risk of transmission. Telemedicine was thus found to be a key technology that was used to mitigate the impact of the COVID-19 pandemic on clinical trial disruptions.

Cloud computing: The use of cloud-based virtual trial platforms allows for the robust and secure collection and synchronization 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. It also allows for the rapid scale-up of trials to serve a large number of patients and the use of multiple.

5G: 5G networks will allow for the use of more connected devices in trials, with enhanced collection of data from wearables and other sensor-based devices. Additionally, 5G will lead to improved delivery tracking and monitoring of cold-chain environments for direct-to-patient investigational medicines.

Artificial intelligence: AI and its application in data analytics have the potential to enhance many aspects of the virtual trial value chain. For example, AI can be used to enhance clinical trial design, identify hypotheses, and minimize potential risks. Machine learning (ML) and natural language processing can be used in participant recruitment by using EHRs and data from connected devices to match patients with trials, and then recommend these trials to the patient or their physician. Given the vast amount of data generated from many different digital sources in virtual trials, AI allows the large-scale mining and advanced analysis of these large data sets to identify trends, flag issues, and enhance interpretations of trial findings.

What are the value chain segments in the virtual clinical trials?

The virtual clinical trials value chain can be broadly split into the following categories: study start-up, trial operations, patient monitoring, and patient data management including electronic data collection (EDC) systems.

What is the impact of COVID-19 on virtual clinical trials?

While levels of disruption have fallen since June 2020, clinical trials are likely to remain disrupted by COVID-19 throughout 2021. The drug development was found to be the most impacted area of the pharma value chain in 2021.

Which are the public and private key players involved in the virtual clinical trials?

The leading public companies includes the Catalent Inc., IBM, Lash Group, Oracle, PRA Health Sciences, Science 37, Syneos Health Inc, Thermo Fisher Scientific Inc., Veeva and World Courier. The examples of private companies include Castor, Covance Inc., DHL, ERT, Marken, Medable, Medical Research Network Ltd., ObvioHealth and Parexel International Corp.

Virtual clinical trials market, by key players

To know more about key players, download a free report sample

Market report scope

Scope

• Key players in the virtual trial space: These include specialist virtual trial providers, CROs, eClinical solution providers, technology companies, contract development and manufacturing organizations (CDMOs), logistics companies, and in-home care providers.
• Thematic briefing including a definition of virtual trials and the different technologies and processes used, such as eConsent, eCOA, telemedicine, direct-to-patient supply, and in-home care, as well as a review of the benefits and challenges to implementing these types of studies.
• Key trends impacting the virtual trial space. Industry trends include the impact of COVID-19 on clinical trials and digital transformation in pharma, rise of the virtual trials specialists and the evolution of CROs, positive impact of virtual trials on accrual rates, and increased focus on patient centricity in trials.
• Technology trends include the role of wearable technology, mHealth, telemedicine, cloud, 5G, blockchain, cybersecurity, and artificial intelligence.
• Regulatory trends include the lack of regulatory frameworks for virtual trials, guidelines issues during COVID-19 to support continuation of clinical research, and the role of non-profit organizations such as the DTRA and CTTI in guiding companies to implement virtual trials. Macroeconomic trends including the increase seen in deals and jobs related to virtual trials since COVID-19.
• Value chain looking at certain aspects of virtual trials, including eConsent, eCOA, telemedicine, direct-to-patient supply, and in-home care.
• Industry analysis with a detailed analysis of virtual trials deals from the Clinical Trials database, as well comprehensive deals, jobs, and Influencer analyses. This section also includes case studies and survey and poll data.
• Profiles of private and public companies in the virtual trials space.

Reasons to Buy

• See who the leading players are in the virtual trials space by company type.
• See how the competitive landscape is evolving, with a review of company activity including mergers and acquisitions (M&A), strategic partnerships and funding deals, as well as a jobs analysis.
• See what trends are driving the use of virtual trials, and what challenges are impeding their uptake
• See which technologies and processes are being used to bring research closer to patients.
• Get a deep dive into clinical trial data, including the impact of COVID-19 on trials, the use of virtual components in trials over the past decade, and how virtual trials have improved trial accrual rates.