ATMP clinical trials in the UK.

IF 2.4 4区医学 Q4 CELL & TISSUE ENGINEERING

Regenerative medicine Pub Date : 2024-11-16 DOI:10.1080/17460751.2024.2427505

Rehma Chandaria, Philippa Rice, Daniel Baston, Finn Willingham, Jacqueline Barry

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引用次数: 0

Abstract

Aims: The UK advanced therapy medicinal product (ATMP) clinical trials database, produced annually by CGT Catapult, aims to assess the progress and state of the UK ATMP clinical development landscape. The aim of this article is to highlight key findings from the database and put them into context within the global landscape and various initiatives intended to attract ATMP developers to the UK.

Method: A targeted search of GlobalData's clinical trial database was performed, followed by refinement so that only trials investigating products meeting ATMP definitions were included, and that each trial was only counted once in the analysis.

Results: The 2023 data show that the number of ongoing ATMP clinical trials in the UK has remained approximately static, in contrast to a 10% reduction reported globally. Approximately 80% of these trials were commercially sponsored. Although most ATMP clinical trials are early phase, there is evidence indicating progression to later phase studies.

Conclusion: The data indicate that the UK remains an attractive region for ATMP clinical trials. Factors including UK government investment in research, regulatory support offered by MHRA, and the Advanced Therapy Treatment Centre (ATTC) network of clinical sites, may contribute to the positive ecosystem available to developers of ATMPs.

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英国的 ATMP 临床试验。

目的：英国先进治疗药物产品（ATMP）临床试验数据库由 CGT Catapult 每年编制一次，旨在评估英国 ATMP 临床开发的进展和状况。本文旨在强调该数据库的主要发现，并将其与全球形势和旨在吸引ATMP开发商来英国的各种举措结合起来：方法：对GlobalData的临床试验数据库进行了有针对性的搜索，然后进行了细化，以便只纳入研究符合ATMP定义的产品的试验，并且每项试验在分析中只计算一次：2023 年的数据显示，英国正在进行的 ATMP 临床试验数量基本保持稳定，而全球报告的数量则减少了 10%。这些试验中约有 80% 由商业赞助。尽管大多数 ATMP 临床试验都处于早期阶段，但有证据表明，后期阶段的研究也在不断进展：数据表明，英国仍然是 ATMP 临床试验的理想地区。英国政府在研究方面的投资、英国医疗药品管理局（MHRA）提供的监管支持以及先进疗法治疗中心（ATTC）的临床基地网络等因素，可能有助于为 ATMP 开发商提供积极的生态系统。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Regenerative medicine 医学-工程：生物医学

CiteScore

4.20

自引率

3.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function*. Since 2006, Regenerative Medicine has been at the forefront of publishing the very best papers and reviews covering the entire regenerative medicine sector. The journal focusses on the entire spectrum of approaches to regenerative medicine, including small molecule drugs, biologics, biomaterials and tissue engineering, and cell and gene therapies – it’s all about regeneration and not a specific platform technology. The journal’s scope encompasses all aspects of the sector ranging from discovery research, through to clinical development, through to commercialization. Regenerative Medicine uniquely supports this important area of biomedical science and healthcare by providing a peer-reviewed journal totally committed to publishing the very best regenerative medicine research, clinical translation and commercialization. Regenerative Medicine provides a specialist forum to address the important challenges and advances in regenerative medicine, delivering this essential information in concise, clear and attractive article formats – vital to a rapidly growing, multidisciplinary and increasingly time-constrained community. Despite substantial developments in our knowledge and understanding of regeneration, the field is still in its infancy. However, progress is accelerating. The next few decades will see the discovery and development of transformative therapies for patients, and in some cases, even cures. Regenerative Medicine will continue to provide a critical overview of these advances as they progress, undergo clinical trials, and eventually become mainstream medicine.