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Virtual Clinical Trials – Thematic Research

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

Virtual clinical trials market, by key players

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Market report scope

Public Companies Catalent Inc., IBM, Lash Group, Oracle, PRA Health Sciences, Science 37, Syneos Health Inc, Thermo Fisher Scientific Inc., Veeva and World Courier.
Private Companies Castor, Covance Inc., DHL, ERT, Marken, Medable, Medical Research Network Ltd., ObvioHealth and Parexel International Corp

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.

 

Key Players

Medable, Science 37, THREAD, ObvioHealth, Studies&Me, Lightship, Parexel, Pharmaceutical Product Development (PPD), Covance, ICON, Syneos Health, UBC, Medidata, ERT, Signant Health, Medrio, Castor, Cloudbyz, TrialSpark, uMotif, AiCure, snapIoT, IBM, Veeva, DHL, World Courier, Marken, Yourway, Illingworth Research, Lash Group, Medical Research Network

Table of Contents

Executive Summary

Players

Thematic Briefing

Trends

• Healthcare Trends

• Technology Trends

• Regulatory trends

• Macroeconomic Trends

Value Chain

• eConsent

• Electronic Clinical Outcome Assessment

• Telemedicine

• In-Home Care

• Direct-to-Patient Supply

Industry Analysis

• The Impact of COVID-19 on Clinical Trials

• Virtual Clinical Trials Analysis

• Impact of Virtual Trials on Trial Accrual Rates

• Survey Data on the Adoption of Virtual Trials

Deals Analysis

• Mergers and Acquisitions

• Strategic Partnerships

• Funding Deals

Jobs Analysis

Case Studies

• The First Virtual Trial, Pfizer’s REMOTE, Was Terminated Due to Low Accrual Rates

• Specialist Vendor Science 37 Is Pioneering the Virtual Trials Space

• PPD Has Partnered with Specialists to Become a Leading Provider of Virtual Trials During the Pandemic

• LEO Innovation Lab Spin-Off Studies&Me Launches as a Virtual CRO With a Focus in Dermatology

• J&J Goes Virtual in Cardiology with its Heartline and CHIEF-HF Trials

Timeline

Healthcare Industry Polls

Social Media Influencers

Companies

• Public Companies

• Private Companies

Appendix

• Abbreviations

• Further Reading

• Related Reports

• Bibliography

• About the Authors

• Our Thematic Research Methodology

• About GlobalData

• Contact Us

List of Tables

Table 1: Healthcare Trends in the Virtual Trials Space

Table 2: Technology Trends in the Virtual Trials Space

Table 3: Regulatory Trends in the Virtual Trials Space

Table 4: Macroeconomic Trends in the Virtual Trials Space

Table 5: Examples of Virtual Trials by Pharmaceutical Companies

Table 6: M&As in the Virtual Trials Space, 2018-2021

Table 7: Examples of Strategic Partnerships in the Virtual Trials Space

Table 8: Examples of Funding Deals in the Virtual Trials Space

Table 9: Examples of Public Companies in the Virtual Trials Space

Table 10: Examples of Private Companies in the Virtual Trials Space

List of Figures

Figure 1: Who Are the Leading Players in the Virtual Trials Space?

Figure 2: Benefits of Virtual Trials

Figure 3: Challenges of Virtual Trials

Figure 4: Virtual Clinical Trials Value Chain

Figure 5: Examples of Virtual Trial Components Provided by Different Provider Types

Figure 6: Examples of eConsent Providers

Figure 7: Examples of eCOA Providers

Figure 8: Examples of Providers with Telemedicine Capabilities

Figure 9: Examples of In-Home Care Providers

Figure 10: Examples of Direct-to-Patient Supply Providers

Figure 11: Ongoing Disruption of Clinical Trial Activity Due to COVID-19

Figure 12: COVID-19 Will Continue to Impact Drug Development Activities in 2021

Figure 13: The Proportion of Trials Utilizing Virtual or Digital Components Has Increased Steadily Since 2004

Figure 14: eDiary Is the Most Common Type of Virtual or Digital Component Used in Trials

Figure 15: Metabolic Disorders Is the Leading Therapy Area for Trials Utilizing Virtual or Digital Components

Figure 16: Breakdown of Trials by Phase and Geography

Figure 17: Top 20 Sponsors of Trials with Virtual or Digital Components

Figure 18: Reasons for Clinical Trial Suspension or Termination, 2011-2021

Figure 19: Proportion of Trials Impacted by Low Accrual Has Decreased Over the Past 10 Years

Figure 20: Trials for Rare Cancers are Most Impacted by Low Accrual Rates

Figure 21: Clinical Trial Disruption Was a Primary Business Concern for the Industry in June 2020

Figure 22: Addressing Clinical Trial Disruptions Related to the COVID-19 Outbreak

Figure 23: COVID-19 Accelerated Use of Virtual Trials

Figure 24: Respondents Expect Virtual Trials to Be Used Frequently Within 1-2 Years

Figure 25: The Number of Deals in the Virtual Trials Space Has Increased Over the Past 12 Months

Figure 26: Partnerships Involving Specialist Virtual Trial Vendors, Most Common Since 2018

Figure 27: Specialist Virtual Trial Vendors Have Received the Most VC Funding Since 2018

Figure 28: Numbers of Posted Jobs Related to Virtual Trials Has Increased Since 2019

Figure 29: Jobs Related to eClinical Technologies Are More Common

Figure 30: Jobs That Mention Virtual or Decentralized Trials Have Increased Since Q1 2020

Figure 31: Virtual Trial Jobs by Geography

Figure 32: Top 20 Companies Posting Jobs Relating to Virtual Trials, 2019-2021

Figure 33: The Apple Heartline Mobile Application

Figure 34: The Virtual Trials Timeline

Figure 35: Therapy Areas Most Suitable for Use of Digital Health Technologies in Clinical Trials

Figure 36: Digital Measures with the Most Potential for Immediate Use in Clinical Trials

Figure 37: Main Benefits of Using Digital Health Technologies in Clinical Trials

Figure 38: Main Barriers to Using Digital Technologies in Clinical Trials

Figure 39: Impact of Digital Health Technologies in Clinical Trials Over the Next Five Years

Figure 40: Clinical Trial Trends in GlobalData’s Digital Pharma Influencer Database, January 2020 to April 2021

Figure 41: Examples of Top Posts Related to Virtual Trials, 2020-2021

Figure 42: Our Five-Step Approach for Generating a Sector Scorecard

Frequently Asked Questions

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.

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 private companies include Castor, Covance Inc., DHL, ERT, Marken, Medable, Medical Research Network Ltd., ObvioHealth and Parexel International Corp.

 

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