Bond Alison, Robertson Tracey, Fletcher Christine, Theogaraj Elizabeth, Jordinson Greg, Askin Scott
Director, Global Regulatory Policy and Intelligence, Amgen Ltd, 4 Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, United Kingdom.
Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
Ther Innov Regul Sci. 2025 May 27. doi: 10.1007/s43441-025-00796-w.
The expansion of the use of decentralised elements in clinical trials in the European Union is driven by the opportunities they offer, including their potential to enhance trial access and improve research outcomes. Despite these potential benefits, several regulatory, operational, and technological challenges impede their widespread adoption. This paper, developed by members of the European Federation of Pharmaceutical Industries and Associations, proposes strategies and policy recommendations to overcome these barriers. Through harmonised regulatory frameworks, improved data validation methods, and increased stakeholder collaboration, the use of decentralised elements could become a standard practice in clinical research as part of the clinical trial toolbox to be deployed as appropriate, thereby enabling innovation and allowing for equitable access to clinical trials for diverse populations.
欧盟临床试验中分散式元素使用的扩大是由它们所带来的机遇驱动的，包括增强试验可及性和改善研究结果的潜力。尽管有这些潜在益处，但一些监管、操作和技术挑战阻碍了它们的广泛采用。本文由欧洲制药工业协会联合会成员撰写，提出了克服这些障碍的策略和政策建议。通过统一的监管框架、改进的数据验证方法以及加强利益相关者合作，分散式元素的使用可以成为临床研究中的标准做法，作为临床试验工具箱的一部分在适当的时候加以应用，从而推动创新并使不同人群能够公平参与临床试验。
