表紙:バーチャル臨床試験:テーマ別調査
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バーチャル臨床試験:テーマ別調査

Virtual Clinical Trials - Thematic Research

出版日: | 発行: GlobalData | ページ情報: 英文 84 Pages | 納期: 即納可能 即納可能とは

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バーチャル臨床試験:テーマ別調査
出版日: 2021年08月05日
発行: GlobalData
ページ情報: 英文 84 Pages
納期: 即納可能 即納可能とは
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  • 概要
  • 図表
  • 目次
概要

従来の臨床試験モデルは時代遅れであり、患者、臨床試験実施施設、スポンサーに多くの問題をもたらしています。これらの問題は、主に、患者の採用率や定着率の低さに関連しており、臨床試験の遅延や高コストにつながっています。バーチャル臨床試験は、デジタル技術やその他の遠隔サービスを利用することで、患者の体験や満足度を向上させるとともに、研究を患者に近づけることで、これらの問題に対する革新的なソリューションを提供します。

COVID-19のパンデミックが起こる以前から、バーチャルコンポーネントを使用する臨床試験が増えていました。COVID-19によるロックダウンと社会的距離を置く措置は、臨床試験に大きな混乱をもたらし、バーチャル臨床試験の利用を加速させました。それまでこのモデルを検討していなかった企業は、事業継続性を維持するために新しい技術や手順を迅速に導入するほかはなく、多くの企業がパンデミック後もバーチャル臨床試験を継続して利用すると考えられます。

この1年半の間に、多くの大手臨床研究機関(CRO)やeClinicalソフトウェアプロバイダーは、これらのサービスに対する需要の高まりに対応して機能を拡張してきました。また、近年、いくつかのバーチャル臨床試験専門企業が登場し、パンデミックの際には大きな注目を集めました。

当レポートは、バーチャル臨床試験について調査しており、ヘルスケアやテクノロジー、規制の動向、臨床試験に対するCOVID-19の影響、業界分析、競合情勢、主要企業などの情報を掲載しています。

目次

目次

  • エグゼクティブサマリー
  • 市場企業
  • テーマ別ブリーフィング
  • 動向
  • ヘルスケアの動向
  • テクノロジー動向
  • 規制動向
  • マクロ経済動向
  • バリューチェーン
  • 電子版同意説明文書
  • 電子臨床転帰評価
  • 遠隔医療
  • 在宅ケア
  • 患者への直接供給
  • 業界分析
  • 臨床試験に対するCOVID-19の影響
  • バーチャル臨床試験分析
  • バーチャルトライアルがトライアル発生率に与える影響
  • バーチャル試験の採用に関する調査データ
  • 取引分析
  • 合併と買収
  • 戦略的提携
  • 資金調達の取引
  • 仕事の分析
  • ケーススタディ
  • 最初のバーチャルトライアルであるPfizerのリモートは、発生率が低いため終了した
  • 専門ベンダーのScience 37のバーチャルトライアルスペース開拓
  • PPDは専門家と提携し、パンデミック時のバーチャル臨床試験の大手プロバイダーとなる
  • LEO Innovation LabがStudies&Meを皮膚科に焦点を当てたバーチャルCROとして発表
  • J&Jは、HeartlineとCHIEF-HF臨床試験で心臓病のバーチャルを実現
  • タイムライン
  • ヘルスケア業界の世論調査
  • ソーシャルメディアインフルエンサー
  • 企業
  • 公開企業
  • プライベートカンパニー

付録

  • 略語
  • 参考文献
  • 関連レポート
  • 参考文献
  • 著者について
  • 当社のテーマ別調査手法
  • GlobalDataについて
  • お問い合わせ
図表

List of Tables

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

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
目次
Product Code: GDHCHT285

The traditional trial model is outdated and causes multiple issues for patients, trial sites, and sponsors. These issues are predominantly related to low patient recruitment and retention rates, leading to trial delays and high costs. Virtual trials offer an innovative solution to these problems by improving patient experiences and satisfaction with the use of digital technologies and other remote services, as well as bringing the research closer to the patient.

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.

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.

Table of Contents

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