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Virtual Clinical Trials – Thematic Research

The increased use of virtual components such as eConsent, telemedicine, remote patient monitoring and wearables in clinical trials over the past decade has led to fewer trial delays or terminations due to low participant numbers. in this report we discuss howCOVID-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, and many companies will continue to use virtual trials post-pandemic.

Kitty Whitney, Director of Thematic Analysis at GlobalData, comments: “GlobalData’s Clinical Trials Database reveals that, of the total 14,000 trials that were suspended, terminated, or withdrawn between 2011 and July 2021, 30% were due to the low number of trial participants. The proportion of trials with low accrual issues decreased from 32% in 2011 to 19% in 2020.

“Additional analysis shows that the percentage of clinical trials using virtual components has increased from 1.3% of all trials in 2011 to 2.5% in 2020. By July 2021, this had increased to 3.5% – no doubt driven by the ongoing impact of COVID-19.”

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Virtual or decentralized clinical trials use digital technologies, such as eConsent, telemedicine, remote patient monitoring and wearables to bring research closer to the patient. They also include direct-to-patient shipping of drugs to a patient’s home, as well as in-home care with mobile nurses.

Whitney continues: “The traditional clinical trial model is outdated and is causing issues for patients, trial sites and sponsors. These include low recruitment and retention rates, which lead to trial delays and increased costs for sponsors.”

Recruitment and retention issues are often due to the distance from a patient’s home to a trial site and the number of visits required. Virtual trials represent a viable solution to these issues and have been shown to reduce patient burden by decreasing or even eliminating physical site visits.

Whitney adds: “While COVID-19 shone a spotlight on virtual trials, data show that the shift towards virtual trials was underway before the pandemic. Companies who are not already integrating virtual components into trials need to adapt their research models to become more patient-centric in order to recruit and retain more participants and improve trial efficiencies overall.”

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 also 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.

Companies mentioned

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

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