TransCelerate BioPharma发布资源以加速行业采用新发布的 ICH E6(R3)指南-动脉网

TransCelerate BioPharma Publishes Resources to Accelerate Industry Adoption of Newly-Released ICH E6(R3) Guidelines

CISION 等信源发布 2025-03-03 21:30

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New tools support sponsors in operationalizing important new guidelines to advance clinical trial conduct worldwide

新工具支持赞助者在实施重要的新指南方面，以推动全球临床试验的进行。

PHILADELPHIA

费城

，

March 3, 2025

2025年3月3日

/PRNewswire/ --

TransCelerate BioPharma

TransCelerate生物制药

(TransCelerate), a global nonprofit organization dedicated to improving the health of patients by accelerating and simplifying the clinical R&D process, today announced the release of

（TransCelerate），一个致力于通过加速和简化临床研发过程来改善患者健康的全球非营利组织，今天宣布发布

13 tools

13个工具

designed to assist pharma R&D sponsors and their ecosystem partners in adapting to the newly issued ICH E6(R3) Good Clinical Practice (GCP) guidelines. The new global guidelines, released in January by the

旨在帮助制药研发赞助商及其生态系统合作伙伴适应新发布的ICH E6(R3)良好临床实践（GCP）指南。今年1月发布的新的全球指南，由

International Council for Harmonization of Technical Requirements for Human Use (ICH)

人用药品技术要求国际协调理事会（ICH）

, emphasize flexibility, efficiency, and data quality in the conduct of clinical trials.

，强调在临床试验的进行中灵活性、效率和数据质量。

In anticipation of these new guidelines, TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today covers six focus areas: risk proportionality, monitoring, trial design, risk management, investigators, and data governance..

为应对这些新指南，TransCelerate 组建了一支专家团队，以评估指南内容并开发工具，支持 ICH E6 (R3) 的实施。今天发布的工具系列涵盖了六个重点领域：风险相称性、监查、试验设计、风险管理、研究者以及数据治理。

'The new guidelines represent an important step forward in protecting the safety, rights, and well-being of trial participants, enhancing the reliability of clinical trial data, and encouraging innovative approaches to trial design and use of technology. They will guide sites, sponsors and their service providers around the world to embrace quality by design and to act in a way that's fit for purpose and proportionate to the associated risks.

“新指南代表了在保护试验参与者的安全、权利和福祉，提高临床试验数据的可靠性，以及鼓励试验设计和技术应用的创新方法方面迈出了重要一步。它们将指导全球各地的研究机构、申办方及其服务提供商采纳质量源于设计的理念，并采取符合目标且与相关风险相称的行动。

These tools are designed to help stakeholders interpret and apply the guidelines and associated concepts,' said .

这些工具旨在帮助利益相关者解释和应用指南及相关概念。

David Nickerson

大卫·尼克森

, Head of Clinical Quality Management at EMD Serono, and executive sponsor of TransCelerate's ICH E6(R3) initiative. 'Innovation in clinical research is at the heart of TransCelerate's work, and we're pleased to facilitate adoption of these new guidelines.'

EMD Serono临床质量管理主管，同时也是TransCelerate ICH E6(R3)倡议的执行发起人。“临床研究中的创新是TransCelerate工作的核心，我们很高兴能够促进这些新指南的采用。”

As a critical part of this initiative, TransCelerate partnered with the

作为该计划的关键部分，TransCelerate 与

Association of Clinical Research Organizations

临床研究组织协会

(ACRO) to co-develop the tools related to risk management and data governance. This collaboration highlights the importance of leveraging shared expertise in addressing key challenges and optimizing clinical trial operations.

(ACRO)共同开发与风险管理和数据治理相关的工具。此次合作突显了利用共享专业知识应对关键挑战和优化临床试验操作的重要性。

'ACRO is proud to partner with TransCelerate in developing essential tools to facilitate the industry's shift to a more flexible, risk-proportionate, and innovative approach to clinical trials, as outlined in the new ICH E6(R3) guidelines,' said

“ACRO 很荣幸能与 TransCelerate 合作，开发必要的工具，以促进业界向更灵活、风险相称且创新的临床试验方法转变，正如新的 ICH E6(R3) 指南中所概述的那样，”

Sandy Kennedy

桑迪·肯尼迪

, Chief Quality, Regulatory Affairs, & Sustainability Officer at Fortrea and Vice-Chair at ACRO. 'By leveraging our collective expertise, we're confident these resources will help sponsors, CROs, and investigator sites optimize clinical trial operations—ultimately accelerating the delivery of new therapies to patients worldwide.'.

首席质量、监管事务和可持续发展官，Fortrea公司，ACRO副主席。“通过利用我们的集体专业知识，我们相信这些资源将帮助申办方、合同研究组织和研究者优化临床试验操作——最终加速新疗法在全球范围内的交付。”

The full suite of tools is available on TransCelerate's website. TransCelerate is seeking input on two additional tools—Data Life Cycle Framework (co-developed with ACRO) and Trial Design Start-Up—as part of a public review. TransCelerate invites interested stakeholders (including sites, CROs, sponsors, academics and clinical trial vendors) to provide their perspectives and comments on these tools .

TransCelerate的网站上提供了完整的工具套件。TransCelerate正在就另外两个工具——数据生命周期框架（与ACRO共同开发）和试验设计启动——寻求意见，作为公开评审的一部分。TransCelerate邀请感兴趣的 stakeholders（包括研究机构、CRO、赞助者、学者和临床试验供应商）对这些工具提供他们的看法和评论。

here

这里

。

TransCelerate will be hosting a webinar,

TransCelerate将举办一场网络研讨会，

Navigating ICH E6(R3): Tools & Resources for Understanding Changes and Supporting Adoption

导航ICH E6(R3)：理解变更和支持采用的工具与资源

, from

，来自

9:00 to 10:30 a.m. EST

上午9:00至10:30（东部标准时间）

打开

March 4, 2025

2025年3月4日

, together with ACRO, to discuss the ICH E6(R3) guidelines and how sponsors can leverage newly developed tools to support implementation. For more information or to register, visit

，连同ACRO一起，讨论ICH E6(R3)指南以及申办方如何利用新开发的工具来支持实施。欲了解更多信息或注册，请访问

https://awarenessandimplementation.transceleratebiopharmainc.com/ich-e6

。

For more information about TransCelerate's ICH E6(R3) work and to access the tools, click

要了解有关 TransCelerate 的 ICH E6(R3) 工作的更多信息并访问这些工具，请点击

here

这里

。

About TransCelerate BioPharma Inc.

关于TransCelerate生物制药公司

TransCelerate BioPharma

TransCelerate生物制药

(TransCelerate) is a non-profit organization that fosters collaboration across the global biopharmaceutical research and development community to drive innovation, simplify clinical trials and help bring new treatments to patients faster, safer and more efficiently. Headquartered in the

（TransCelerate）是一个非营利组织，致力于推动全球生物制药研发领域的合作，以推动创新、简化临床试验，并帮助更快、更安全、更高效地将新疗法带给患者。总部位于

Philadelphia

费城

area, TransCelerate has 20 member companies and a robust portfolio of initiatives focused on transforming connectivity, enabling information sharing and reuse, and driving innovative trial designs. For more information, please visit

区域，TransCelerate 拥有20家成员公司和一系列强大的项目组合，专注于转变连通性、实现信息共享和重用，以及推动创新的试验设计。欲了解更多信息，请访问

transceleratebiopharmainc.com

。

SOURCE TransCelerate BioPharma

资料来源：TransCelerate BioPharma

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