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<p>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.</p>

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Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年5月27日

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  • Alison Bond,
  • Tracey Robertson,
  • Christine Fletcher,
  • Elizabeth Theogaraj,
  • Greg Jordinson,
  • Scott Askin

摘要

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.