| 1. PREFER | IMI Innovative Medicines Initiative
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Innovative Medicines Initiative-PREFER (IMI PREFER) |
Europe |
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| 2. Patient science and engagement updates from CDRH
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Center for Devices and Radiological Health (CDRH) |
North America—USA |
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| 3. Council for International Organizations of Medical Sciences (CIOMS). Patient involvement in the development, regulation and safe use of medicines
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Council for International Organizations of Medical Sciences (CIOMS) |
Global |
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| 4. FDA amplifies ‘patient science’ in product regulation
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US Food and Drug Administration (FDA) |
North America—USA |
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| 5. EUnetHTA relative effectiveness assessments: efforts to increase usability, transparency and inclusiveness
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Europe Network for Health Technology Assessment (EUnetHTA) |
Europe |
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| 6. ISPOR Webinar—differentiating between patient preferences, patient reported outcomes and patient engagement
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The Professional Society for Health Economics and Outcomes Research (ISPOR) |
Global |
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| 7. Defining patient centricity with patients for patients and caregivers: a collaborative endeavour
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Article in BMJ Innov. (definition of PE) |
Global |
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| 8. Engagement framework: EMA and patient, consumers and their organisations
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European Medicines Agency (EMA) |
Europe |
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| 9. The added value of patient engagement in early dialogue at EMA: scientific advice as a case study
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EMA |
Europe |
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| 10. 360° HTA patient involvement
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Patient And Citizen Involvement group at HTAi (Health Technology Assessment International) |
UK |
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| 11. Proposals for legislative changes for clinical trials
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Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA), in collaboration with an Expert Working Group of stakeholders from across the clinical research sector, including patient representation |
UK |
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| 12. Patient engagement in the design and conduct of medical device clinical studies
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FDA |
North America—USA |
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| 13. Stakeholder Engagement Biennial Report 2020–2021
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EMA |
Europe |
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| 14. Putting people first—embedding public involvement in health and social care research
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National Health Service (NHS) Health Research Authority |
UK |
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| 15. Guide to patient involvement in rare disease therapy development
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EveryLife Foundation, Biotechnology Innovation Organisation, National Health Council, and Pharmaceutical Research and Manufacturers of America (PhRMA) |
North America—USA |
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| 16. Impact of patient involvement
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Canadian Agency for Drugs and Technologies in Health (CADTH) |
North America—USA |
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| 17. Ministry of health labour and welfare: third term of the basic plan to promote cancer control
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Ministry of Health Labour and Welfare |
Asia—Japan |
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| 18. Pharmaceuticals and Medical Devices Agency—guidance on patient participation
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Pharmaceuticals and Medical Devices Agency (PMDA) |
Asia—Japan |
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| 19. Patient and Public Involvement (PPI) guide book
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Japan Agency for Medical Research and Development (AMED) |
Asia—Japan |
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| 20. 2021 Dialogue with the Agency for Care Effectiveness (ACE) Consumer Engagement and Education (CEE) Team: The Future of Patient and Public Involvement in Health Technology Assessment in Singapore
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Centre of Regulatory Excellence (CoRE) at Duke-NUS Medical School, and Agency for Care Effectiveness (ACE) |
Asia—Singapore |
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| 21. The Future of Patient and Public Involvement in Health Technology in Singapore
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CoRE at Duke-NUS Medical School, and ACE |
Asia—Singapore |
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| 22. Helping patients become involved in healthcare decision-making
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ACE |
Asia—Singapore |
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| 23. A framework for action to improve patient and public involvement in health technology assessment
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Article—health technology assessment (HTA) |
Latin America—Brazil |
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| 24. EMA Patients' and Consumers' Working Party (PCWP) Initiative
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EMA |
Europe |
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| 25. EMA Public Hearings
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EMA |
Europe |
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| 26. HTA—how patient involvement is making a difference in HTA perspectives of impact Webinar
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HTAi Interest Group for Patient and Citizen Involvement in HTA (PCIG) |
Global |
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| 27. Proposed ICH Guideline Work to Advance Patient Focused Drug Development
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) |
Global |
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| 28. The road to treating chronic active Epstein-Barr virus infection in collaboration with citizens
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AMED |
Asia—Japan |
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| 29. Patients’ voices shape the drug development process through a preference survey
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Pfizer |
North America—USA |
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| 30. Patient involvement in health technology assessment agencies: a systematic literature review by alira health
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Alira Health—HTA literature review |
Global |
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| 31. Regulatory Affairs Professionals Society (RAPS)—FDA official: patients play an increasing role in rare disease drug development
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Article—FDA |
North America—USA |
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| 32. African Medicines Agency (AMA)
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African Medicines Agency (AMA) |
Africa |
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| 33. Patient Focused Medicines Development (PFMD)—PE and PXD project
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Patient Focused Medicines Development (PFMD) |
Global |
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| 34. Highlighting recent trends in the fast-evolving patient engagement and patient experience data landscape
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PFMD |
Global |
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| 35. Building from patient experiences to deliver patient-focused healthcare systems in collaboration with patients: a call to action
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Article—PFMD |
Global |
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| 36. The fusion of patient engagement and patient experience data: strengthening global focus and stakeholder convergence
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PFMD |
Global |
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| 37. PEOF: the fusion of patient engagement and patient experience data
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PFMD |
Global |
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| 38. “You cannot have patient experience data if patient engagement has not taken place”
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PFMD |
Global |
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| 39. FDA patient focused drug development glossary
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FDA |
North America—USA |
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| 40. Qualification opinion of IMI PREFER
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EMA—Qualification Opinion of IMI PREFER |
Europe |
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| 41. Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation
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FDA |
North America—USA |
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| 42. European Collaboration between regulators and healthtechnology assessment bodies
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EMA and Europe Network for Health Technology Assessment (EUnetHTA) |
Europe |
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| 43. EUnetHTA 21
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EUnetHTA |
Europe |
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| 44. ICMRA statement on international collaboration to enable real-world evidence (RWE) for regulatory decision making
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International Coalition of Medicines Regulatory Authorities (ICMRA)—EMA, Health Canada, and FDA |
Global |
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| 45. EMA multi-stakeholder workshop: patient experience data in medicines development and regulatory decision-making
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EMA |
Europe |
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| 46. NICE real-world evidence framework
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National Institute for Health and Care Excellence (NICE) |
UK |
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| 47. Patient Involvement Strategy 2021–2025
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MHRA |
UK |
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| 48. Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations
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Article—FDA |
North America—USA |
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| 49. CDE guiding principles for the application of patient report outcomes in drug clinical development (trial)
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Center for Drug Evaluation (CDE) |
Asia—China |
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| 50. The Center for Drug Evaluation’s (CDE) draft PRO guidance
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CDE |
Asia—China |
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| 51. The global patient experience data navigator
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PFMD |
Global |
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| 52. Guidance 2—patient-focused drug development: methods to identify what Is important to patients—guidance for industry, food and drug administration staff, and other stakeholders
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FDA (US Department of Health and Human Services Food and Drug Administration), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) |
North America—USA |
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| 53. NICE real-world evidence framework: rationale and background
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NICE |
UK |
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