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<p>As digital measures continue to transform drug development, clinical practice, and patient experience, there is an increasing need for standardization in the development, validation, qualification, and regulatory acceptance of these measures. A multi-stakeholder project, led by the Digital Evidence Ecosystem &amp; Protocols (DEEP), in collaboration with EFPIA (European Federation of Pharmaceutical Industries and Associations) and the EMA (European Medicines Agency) was initiated to explore whether the DEEP platform could foster and facilitate regulatory qualification of digital measures in several ways: e.g.: pre-competitive collaboration for evidence generation, structured presentation of evidence to support qualification requests and explore utility with a view to lifecycle management of qualified measures, as well as the utility of the DEEP platform to potentially facilitate aspects of the EMA Qualification of Novel Methodologies. Working with stakeholders from eight pharmaceutical companies, a real-life use case was explored to investigate the potential of the DEEP platform and Stack Model for procedural and life-cycle management. The proof of concept supported the DEEP stack model’s utility to support regulatory review and acceptance of novel endpoints through standardization, data reusability, and structured approach to validation of digital endpoints. This paper presents the methodology used to conduct the proof of concept in a structured approach, as well as the results and learnings and can serve as a basis for how to structure other explorations with regulatory authorities, following principles of agility.</p>

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Navigating the EMA qualification of novel methodologies for digital endpoints: lessons from the DEEP project proof of concept

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月10日

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  • Lada Leyens,
  • Mireille Muller,
  • Cathelijne de Gram,
  • Bola Grace,
  • Rauha Tulkki-Wilke,
  • Parla Yuksel,
  • Aude Clement,
  • Igor Knezevic,
  • Felicitas Illa Schmid,
  • Kai Langel,
  • Claire Lansdall,
  • Carrie Annalice Northcott

摘要

As digital measures continue to transform drug development, clinical practice, and patient experience, there is an increasing need for standardization in the development, validation, qualification, and regulatory acceptance of these measures. A multi-stakeholder project, led by the Digital Evidence Ecosystem & Protocols (DEEP), in collaboration with EFPIA (European Federation of Pharmaceutical Industries and Associations) and the EMA (European Medicines Agency) was initiated to explore whether the DEEP platform could foster and facilitate regulatory qualification of digital measures in several ways: e.g.: pre-competitive collaboration for evidence generation, structured presentation of evidence to support qualification requests and explore utility with a view to lifecycle management of qualified measures, as well as the utility of the DEEP platform to potentially facilitate aspects of the EMA Qualification of Novel Methodologies. Working with stakeholders from eight pharmaceutical companies, a real-life use case was explored to investigate the potential of the DEEP platform and Stack Model for procedural and life-cycle management. The proof of concept supported the DEEP stack model’s utility to support regulatory review and acceptance of novel endpoints through standardization, data reusability, and structured approach to validation of digital endpoints. This paper presents the methodology used to conduct the proof of concept in a structured approach, as well as the results and learnings and can serve as a basis for how to structure other explorations with regulatory authorities, following principles of agility.