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评论:西北伦敦临床试验联盟:临床试验实施的效率与创新。

Commentary: The North West London Clinical Trials Alliance: efficiency and innovation in clinical trial delivery.

机构信息

Cancer Research UK Convergence Science Centre, Imperial College London & The Institute of Cancer Research, London, UK.

NIHR Research Delivery Network, London, UK.

出版信息

Trials. 2024 Jul 29;25(1):509. doi: 10.1186/s13063-024-08344-x.

Abstract

BACKGROUND

The set-up, activation, and delivery of clinical trials is pivotal for the advancement of medical science, serving as the primary mechanism through which new therapeutic interventions are validated for clinical use. Despite their critical role, the execution of these trials is often encumbered by a multitude of challenges. The North West London Clinical Trials Alliance (The Alliance) was established to address these complexities. It aims to bridge the gap between emerging scientific research and its clinical application through strategic collaborations among healthcare and research entities, thereby enhancing the regional ecosystem for clinical trials.

MAIN TEXT

This commentary aims to offer clarity on the fundamental insights that underlie The Alliance, providing a comprehensive understanding of its operational structure and the ecosystem it has fostered to optimise clinical trial delivery and revenue generation. The strategy employed by The Alliance centres on the cultivation of strategic partnerships across a broad spectrum of stakeholders. This approach addresses key operational challenges in clinical trial management, facilitating improvements in the development, setup, activation, and recruitment stages. Notably, The Alliance has reduced the average time to initiate trials to 19 days, compared to the standard 75 days typically observed for commercial setups in North West London. The effectiveness of The Alliance's framework was notably demonstrated during the COVID-19 pandemic, particularly with the expedited recruitment performance in the Janssen COVID-19 vaccine study conducted at Charing Cross Hospital. This instance highlighted the Alliance's capability to meet and exceed recruitment targets promptly while maintaining diversity within study cohorts. Additionally, The Alliance has effectively harnessed digital technology and infrastructure, enhancing its attractiveness to commercially funded studies and illustrating a sustainable model for clinical trial financing and execution.

CONCLUSION

The North West London Clinical Trials Alliance represents a strategic response to the conventional challenges faced in clinical trial management, emphasising the importance of cross-sectoral collaboration and resource optimisation. Its efforts, particularly highlighted by its response to the COVID-19 pandemic, provide a case study in enhancing trial delivery and efficiency with significant implications for both regional and global clinical trials research communities.

摘要

背景

临床试验的设立、启动和实施对于医学科学的发展至关重要,是验证新治疗干预措施是否可用于临床的主要机制。尽管它们具有重要作用,但这些试验的执行往往受到众多挑战的困扰。西北伦敦临床试验联盟(联盟)的成立是为了解决这些复杂性问题。它旨在通过医疗保健和研究实体之间的战略合作,弥合新兴科学研究与其临床应用之间的差距,从而增强临床试验的区域生态系统。

主要文本

本文旨在阐明联盟的基本见解,全面了解其运营结构和培育的生态系统,以优化临床试验的交付和收入生成。联盟的策略侧重于在广泛的利益相关者中培养战略伙伴关系。这种方法解决了临床试验管理中的关键运营挑战,促进了开发、设立、启动和招募阶段的改进。值得注意的是,与西北伦敦的商业设置通常需要 75 天相比,联盟将启动试验的平均时间缩短到了 19 天。联盟框架的有效性在 COVID-19 大流行期间得到了显著体现,特别是在查令十字医院进行的杨森 COVID-19 疫苗研究中加快了招募表现。这一实例突出了联盟在迅速满足和超过招募目标的同时,保持研究队列多样性的能力。此外,联盟还有效地利用了数字技术和基础设施,提高了对商业资助研究的吸引力,并为临床试验融资和执行展示了可持续的模式。

结论

西北伦敦临床试验联盟代表了对临床试验管理中传统挑战的战略应对,强调了跨部门合作和资源优化的重要性。它的努力,特别是在 COVID-19 大流行期间的应对措施,为提高试验交付和效率提供了一个案例研究,对区域和全球临床试验研究社区都具有重要意义。

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