Patient engagement (PE) and patient experience data (PED) are increasingly valued but lack consistent integration and visibility in regulatory and HTA decision making.
This CIRS multi-stakeholder workshop explored practical steps for embedding meaningful PE and PED in regulatory and HTA processes.
Background
Patient engagement (PE) and the use of patient experience data (PED) are now recognised as essential elements in the development, regulation, and health technology assessment (HTA) of new medicines, helping ensure decisions reflect patient needs and priorities.
Building on earlier efforts — including the 2015 Centre for Innovation in Regulatory Science (CIRS) workshop and work by the Clinical Trials Transformation Initiative (CTTI), Patients Active in Research and Dialogues for an Improved Generation of Medicines (PARADIGM), and Patient-Focused Medicines Development (PFMD) — CIRS formed a Topic Group in 2022 of various stakeholders to suggest research activities in this area for the CIRS 2024-2026 Research Agenda. This culminated in a multi-stakeholder workshop held in the UK on 1–2 October 2025, which examined how patient input is being integrated and communicated in regulatory and HTA decision making.
The workshop brought together representatives from patient organisations, industry, regulators, HTA agencies and payers to discuss challenges, opportunities, share case studies, and develop recommendations for improving the measurement and articulation of patient input in agency assessments.
Key findings from the workshop
