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Background <p>As healthcare stakeholders aim to support patient-centered care, patients play an increasingly important role in pharmaceutical and medical technology development and healthcare decision-making. Patient engagement (PE), patient experience data (PED), and meaningful integration of PE to enrich PED have been evolving rapidly. This landscape review focuses on emerging PE/PED practices and guidelines in 2023.</p> Methods <p>References published between January–December 2023 on the use of PE and PED from health technology assessment (HTA) and regulatory bodies in different countries, three peer-reviewed journals, and referred resources from collaborators were analyzed. These references were compared with those in our previous publication (August 2021–January 2023, 17-month period).</p> Results <p>Overall, 28 references from HTA/regulatory bodies, 26 from peer-reviewed articles, and 17 referred resources were identified. Eight references on PE and PED integration (PE + PED) were identified in 2023 from HTA/regulatory bodies, compared with none in the previous 17-month analysis. Emerging trends on the role of PE, PED, and real-world evidence in HTA/regulatory deliberations, transparency and geographic variations in the use of such evidence and practices, and gaps thereof have been highlighted.</p> Conclusions <p>The increase in PE, PED, and PE + PED references worldwide in 2023 versus the prior 17-month analysis suggests accelerated adoption of PE + PED practices. However, a need remains for comprehensive, actionable guidance on best practices for use of PE and PED for harmonization and incorporation into HTA/regulatory processes. Patient input—essential for evidence-based decision-making—provides valuable insights that enhance care quality, treatment relevance and effectiveness, and builds trust and sustainability.</p>

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Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: Where Are We Today?

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年4月10日

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  • Neil Bertelsen,
  • Elisabeth Oehrlein,
  • Bronwyn Lewis,
  • Tiffany Westrich-Robertson,
  • Jim Elliott,
  • Tom Willgoss,
  • Nidhi Swarup,
  • Ify Sargeant,
  • Oishika Panda,
  • Maria M. Marano,
  • Hayley Chapman,
  • Nicholas Brooke

摘要

Background

As healthcare stakeholders aim to support patient-centered care, patients play an increasingly important role in pharmaceutical and medical technology development and healthcare decision-making. Patient engagement (PE), patient experience data (PED), and meaningful integration of PE to enrich PED have been evolving rapidly. This landscape review focuses on emerging PE/PED practices and guidelines in 2023.

Methods

References published between January–December 2023 on the use of PE and PED from health technology assessment (HTA) and regulatory bodies in different countries, three peer-reviewed journals, and referred resources from collaborators were analyzed. These references were compared with those in our previous publication (August 2021–January 2023, 17-month period).

Results

Overall, 28 references from HTA/regulatory bodies, 26 from peer-reviewed articles, and 17 referred resources were identified. Eight references on PE and PED integration (PE + PED) were identified in 2023 from HTA/regulatory bodies, compared with none in the previous 17-month analysis. Emerging trends on the role of PE, PED, and real-world evidence in HTA/regulatory deliberations, transparency and geographic variations in the use of such evidence and practices, and gaps thereof have been highlighted.

Conclusions

The increase in PE, PED, and PE + PED references worldwide in 2023 versus the prior 17-month analysis suggests accelerated adoption of PE + PED practices. However, a need remains for comprehensive, actionable guidance on best practices for use of PE and PED for harmonization and incorporation into HTA/regulatory processes. Patient input—essential for evidence-based decision-making—provides valuable insights that enhance care quality, treatment relevance and effectiveness, and builds trust and sustainability.