ReviewTherapeutic innovation & regulatory science2024
Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review.
Review in Therapeutic innovation & regulatory science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed.
- Patient-Reported Outcomes Used for Regulatory Approval of Medicines Indicated for the Treatment of Dermatological Diseases Authorized in the European Union Between 1998 and 2024.Therapeutic innovation & regulatory science · 2026Article
- Exploring Patient Perspectives on Upper Tract Urothelial Cancer: A Qualitative Interview Study.Oncology and therapy · 2026Article
- Bridging the gap: enhancing patient and public involvement in dermatology PRO research.Journal of patient-reported outcomes · 2026Article
- Advancing the systematic implementation of patient experience data in healthcare decision-making: multi-stakeholder insights on barriers, opportunities and policy ways forward.Health research policy and systems · 2026Article
- Experiences and treatment perspectives of adolescents and young adults with achondroplasia and caregivers: a qualitative interview study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- An International Survey of Patients with Ataxia: Trends in Patient-Reported Symptoms.Cerebellum (London, England) · 2026Article
- Advancing the Science of Patient Input in Drug Research and Development.Journal of participatory medicine · 2026Article
- Patient organizations involvement in healthcare: a rapid review and conceptual framework.Globalization and health · 2026Review
- Multi-stakeholder use of patient experience data (PED): current state and future opportunities for the application of PED to inform decision-making.Journal of patient-reported outcomes · 2026Review
- Global Stakeholder Perspectives on Real-World Data and Evidence in Health Technology Assessment: An Exploratory Study.Healthcare (Basel, Switzerland) · 2026Article
- Evaluation of the methodology of independent Community Advisory Boards in health products research and development: a mixed-methods cross-sectional survey study.Research involvement and engagement · 2026Article
- [Including the perspectives of people affected by disease (patients and others) at the Institute for Quality and Efficiency in Health Care (IQWiG) with a focus on the development of health information].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2026Review
- Identification and Description of Regulatory and Health Technology Assessment Agencies' Guidance Related to Patient Experience Data in North America, Europe, and Asia Pacific.Therapeutic innovation & regulatory science · 2025Article
- Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap.Therapeutic innovation & regulatory science · 2025Article
- From Architecture to Outcomes: Mapping the Landscape of Digital Twins for Personalized Diabetes Care-A Scoping Review.Journal of personalized medicine · 2025Review
- Quality in qualitative evidence: new best practice principles from NICE's real-world evidence framework.Journal of comparative effectiveness research · 2025Article
- Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: Where Are We Today?Therapeutic innovation & regulatory science · 2025Review
- Enhancing Patient Engagement in HTA: Using Consensus Research to Overcome PICO Scoping Challenges Under the EU HTAR.Journal of market access & health policy · 2025Article
- Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives.Therapeutic innovation & regulatory science · 2025Article
- A Consistent Lack of Consistency: Definitions, Evidentiary Expectations and Potential Use of Meaningful Change Data in Clinical Outcome Assessments Across Stakeholders. Results from a DIA Working Group Literature Review and Survey.Therapeutic innovation & regulatory science · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWorking with patients through meaningful patient engagement (PE) and incorporating patient experience data (PXD) is increasingly important in medicines and medical device development. However, PE in the planning, organization, generation, and interpretation of PXD within regulatory and health technology assessment (HTA) decision-making processes remains challenging. We conducted a global review of the PE and PXD landscape to identify evolving resources by geography to support and highlight the potential of integration of PE and PXD in regulatory assessment and HTA.
methodsA review of literature/public information was conducted (August 2021-January 2023), led by a multistakeholder group comprising those with lived or professional experience of PE and PXD, to identify relevant regulatory and HTA initiatives and resources reviewed and categorized by geography and focus area.
resultsOverall, 53 relevant initiatives/resources were identified (global, 14; North America, 11; Europe, 11; Asia, nine; UK, six; Latin America, one; Africa, one). Most focused either on PE (49%) or PXD (28%); few (11%) mentioned both PE and PXD (as largely separate activities) or demonstrated an integration of PE and PXD (11%).
conclusionsOur analysis demonstrates increasing interest in PE, PXD, and guidance on their use individually in decision-making. However, more work is needed to offer guidance on maximizing the value of patient input into decisions by combining both PE and PXD into regulatory and HTA processes; the necessity of integrating PE in the design and interpretation of PXD programs should be highlighted. A co-created framework to achieve this integration is part of a future project.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.