表紙:分散型臨床試験 (Decentralized Clinical Trials) の将来
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分散型臨床試験 (Decentralized Clinical Trials) の将来

The Future of Decentralized Clinical Trials

出版日: | 発行: FirstWord | ページ情報: 英文 | 納期: 即日から翌営業日

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分散型臨床試験 (Decentralized Clinical Trials) の将来
出版日: 2020年09月23日
発行: FirstWord
ページ情報: 英文
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

パンデミック以前、多くの企業は分散型臨床試験(DCT)の可能性を探求することに興味を持っていました。現在、このアプローチは、身体的接触を最小限に抑えながら患者を募集および維持するために不可欠だとみなされています。より速い結果、より短い商品化までの時間、一般諸経費の削減、および現場の負担軽減など、多くのメリットがあります。 DCTは、従来の臨床試験の実践に取って代わることは決してないかもしれませんが、プロセスを根本的に合理化する可能性があります。多くの業界専門家は、分散型研究が「ニューノーマル」になる可能性があると考えており、DCTモデルにスムーズに移行するために医薬品企業はどのような変更を加える必要があり、どのような課題を克服する必要があるのかという問題を生み出しています。

当レポートは、分散型臨床試験 (Decentralized Clinical Trials) について取り上げ、ケーススタディ、DCTの新しい使用とそのメリット、克服すべき規制、オペレーションおよび患者の課題、医薬品企業とCROが把握・対応する必要のある9つの重要な問題などについて分析しています。

目次

主題の要約

調査手法と目的

重要考察のサマリー

問題と考察

  • DCTに対するCOVID-19の影響
    • 問題のサマリー
    • 質問
    • 重要考察
    • 引用符のサポート
    • インテリジェンス表
  • 求人・インテリジェント患者オリエンテーション
  • 患者経験 (PX:ペイシェントエクスペリエンス) ツール
  • データの所有権とセキュリティ
  • データ管理
  • 患者の安全
  • DCTを促進する革新的な技術とツール
  • DCTの政策環境
  • DCTのパートナーシップ
  • 将来のDCT成功の保証
目次
Product Code: 596201714

COVID-19 has driven innovation in clinical trials, but what happens next and how can pharma prepare?

Pre-pandemic many companies were curious to explore the potential of decentralized clinical trials (DCTs), but now see this approach as a necessity for recruiting and retaining patients while minimizing physical contact. The advantages are many: faster results, shorter time to market, reduced overheads and reduced on-site burden. While DCTs may never replace traditional clinical trial practice it has the potential to radically streamline the process. Many industry thinkers believe decentralized studies may become the 'new normal,' raising the question: what changes must pharma make to smoothly transition to the DCT model and what challenges must it overcome?

To help you understand the drivers and limiters of a DCT future we interviewed, in The Future of Decentralised Clinical Trials, knowledgeable experts to give you a clear perspective of the current environment and future development pathways this rapidly emerging field could take.

Experts explore decentralized clinical trials

  • What factors/issues in patient experience should researchers consider in DCTs?
  • Setting meaningful clinical endpoints for DCTs is critical-what does pharma need to take into account?
  • How will companies overcome data ownership, privacy and security challenges?
  • What advantages will pharma get from the effective use of continuous patient data?
  • In what ways can pharma use predictive analytics/modelling to increase the likelihood of DCT study success?
  • How might the regulatory landscape change post-COVID-19 and what will it look like in the next 5-10 years with respect to DCTs?

What are Decentralized Clinical Trials?

The term 'decentralized clinical trial' has often been used interchangeably with virtual, remote and hybrid trials. While definitions vary, the key difference between approaches is that while 'virtualized' can refer to trials that are conducted without human participants, in silico, or to trials that require no site visits, 'decentralized' is more inclusive and can refer to fully remote studies or hybrid studies that use a blend of technology and traditional trial methods.

Read Virtual Medical Conferences: The new normal? to hear from leaders in the field about their virtual conference experiences over the last few months of the pandemic as well as their thoughts on what the future holds for the medical events sector.

What our experts say...

"Virtual meetings have expanded the global reach: Virtual meetings broadens accessibility, enabling people that would otherwise have not been able to participate, to take part. In addition, it also widens accessibility in terms of conference content through having information available on-demand. This way, knowledge can be harnessed from any location at one time and be shared with a wider audience." R'Kes Starling, CEO Reveles Clinical Services.

"The rate-limiter for DCTs tend to be the availability of robust endpoints that can be captured at a decentralized site. The slow but steady adoption of digital endpoints will be the catalyst for more studies to embrace DCTs and decentralized research methods. Out-dated and fragile endpoints that require patients to visit a site to avoid any semblance of noise will remain a barrier to adoption; sponsors must embed time into their development plan to evaluate and invest in novel digital endpoints." Craig Lipset, Founder of Clinical Innovation Partners.

"The regulatory landscape is already changing to support decentralized study approaches such as eConsent, eCOA, sensors, telehealth, and device-reported outcomes. As these solutions become more of the standard, regulators are expected to detail these solutions by name within updated regulations so that these solutions are less 'grey' in their descriptions of use and context in clinical trials. Many in our industry (including me) believe that hybrid decentralized studies will become the norm with regulators in the next 5-10 years." John Reites, President of THREAD.

Case Studies

  • How the FDA is facilitating DCTs during the COVID-19 pandemic
  • How Alexa is expected to enhance the patient experience of DCTs

What to expect

  • A detailed report which explores the emerging use of decentralized clinical trials, the practical advantages they provide and the regulatory, operational and patient challenges that must be overcome
  • An examination of 9 key issues which pharma and CROs need to understand and respond to
  • 17 targeted questions put to experts
  • Their perceptive responses that provided 44 insights supported by 42 directly quoted comments

Expert contributors

Contributors to this report were carefully selected and screened to ensure they:

  • Are a manager or executive who has been involved in planning or conducting DCTs
  • Had at least 3 years' experience in the field of pharma R&D
  • Had direct experience in creating or implementing solutions or strategies for DCTs in the last 24 months

Contributors to the report

  • Craig Lipset is a clinical trial expert, serving as an advisor and member of the Board of Directors for several technology and biopharmaceutical companies. His focus is on developing the intersection between research, digital solutions and patient engagement. For this report, Craig leverages his clinical trial experience, which includes eight years as the Head of Clinical Innovation at Pfizer. Craig also designed and launched the first fully remote virtual clinical trial for a new drug, among other innovations. He has been recognized for his achievements by reputable life science publications and is currently an Adjunct Assistant Professor in Health Informatics at Rutgers University.
  • R'Kes Starling is the Chief Executive Officer at Reveles Clinical Services. He is responsible for Pharmacy and Clinical Research Operations Management, with a focus on decentralized clinical trials. His expertise in this field encompasses hybrid/virtual clinical trials, clinical development Phases I-IV and policy and procedure development, among others. R'Kes also has over 15 years of experience in core competencies such as operations, regulatory compliance, sales, customer retention strategy and pharma distribution markets. His patient-centric approach has resulted in consistently high performances in his clinical trial operations.
  • John Reites is the President of THREAD, a unified global platform designed for Sponsors and CROs that decentralizes and automates how clinical research is conducted to make studies more efficient, comprehensive and inclusive. With over 18 years of experience in digital health and global drug development, John has strived to simplify clinical trials through decentralization and advance remote data capture from participants and sites during, in between and in lieu of in-clinic visits. John is a frequent keynote speaker at top tier industry events and serves as a guest lecturer on digital health, clinical research innovation and entrepreneurship at Duke University in the U.S.

Why choose FirstWord FutureViews?

FirstWord's FutureViews reports analyze in detail significant emerging technology and market trends that industry executives need to understand if they are to manage the opportunities and challenges that lay ahead. These concise and highly focussed reports:

  • Are based on primary research with experts whose knowledge and current experience is proven
  • Present clear expert insights free from secondary source information and spurious observations
  • Include only the latest research and content-we don't reuse or recycle content

Table of Contents

Subject synopsis

Research methodology and objectives

Key insights summary

Issues and insights

  • The impact of COVID-19 on DCTs
    • Issue summary
    • Questions
    • Key insights
    • Supporting quotes
    • Intelligence exhibits
  • Recruitment and intelligent patient on-boarding
    • Issue summary
    • Questions
    • Key insights
    • Supporting quotes
  • Patient experience tools
    • Issue summary
    • Questions
    • Key insights
    • Supporting quotes
    • Intelligence exhibits
  • Data ownership and security
    • Issue summary
    • Questions
    • Key insights
    • Supporting quotes
  • Data management
    • Issue summary
    • Questions
    • Key insights
    • Supporting quotes
    • Intelligence exhibits
  • Patient safety
    • Issue summary
    • Questions
    • Key insights
    • Supporting quotes
  • Innovative technologies and tools facilitating DCTs
    • Issue summary
    • Questions
    • Key insights
    • Supporting quotes
    • Intelligence exhibits
  • The policy environment of DCTs
    • Issue summary
    • Questions
    • Key insights
    • Supporting quotes
  • Partnerships for DCTs
    • Issue summary
    • Key insights
    • Supporting quotes
  • Ensuring the success of future DCTs
    • Issue summary
    • Key insights
    • Supporting quotes
    • Intelligence exhibits