European Patients Forum, logo.

UNIFIED

Project information 

  • Full title: Unifying Framework for Patient-Centred Clinical-study Endpoints Derived from Digital Health Technologies
  • Duration: 60 months (November 2025 – October 2030)
  • Status: Ongoing  
  • Funding programme: Innovative Health Initiative Joint Undertaking (IHI JU), Grant agreement No 101136379

What will the project do? 

  • UNIFIED will develop a harmonised, evidence-based framework that integrates patient preference information (PPI), clinical outcome assessments (COAs), and digital health technology measures (DHTM) to capture and reflect true patient value in healthcare decisions.
  • UNIFIED will establish consensus-based recommendations to guide the integration of patient-centred evidence into healthcare, regulatory, HTA, and industry decision-making, including methods to define minimal (clinically) important difference (MCID/MID) from the patient perspective.
  • UNIFIED will achieve multi-stakeholder alignment and adoption of the UNIFIED Framework, bringing together patients, regulators, HTA bodies, payers, clinicians, academics, and industry, to ensure healthcare innovation and evaluation are driven by what patients truly value.

What are the expected outcomes? 

  • To achieve greater alignment among stakeholders on consistent methods to assess and demonstrate patient-centered value in healthcare.
  • To improve health outcomes and healthcare efficiency by enhancing treatment adherence and uptake of effective interventions.
  • To secure formal recognition and adoption of the UNIFIED Framework across regulatory, HTA, and industry settings, establishing patient value as a foundational principle in healthcare decision-making.

What is EPFs’ role? 

  • EPF, in close collaboration with CCI, ECPO, EPDA, and Cassie +Friends, will coordinate the establishment of a Patient Advisory Group (PAG) and oversee patient engagement activities throughout the project lifecycle. The PAG members will be selected through a “call for interest” coordinated by EPF. The PAG representatives will play a crucial role in shaping the patient adoption proposal, ensuring the UNIFIED Framework aligns with real patient needs and expectations.
  • EPF will serve as a central advocate for the patient perspective, ensuring that real-world patient insights shape research approaches, while promoting ethical, patient-centered practices that address data privacy, accessibility, and usability to guide decision-making.

Why does this matter for patients? 

  • To enable personalised, patient-centered care: UNIFIED is applied across five key use cases: paediatric radiation oncology, lung cancer, obesity, juvenile idiopathic arthritis, and Parkinson’s disease. It enables personalised, patient-centered care by capturing patient preferences, real-world experiences, and disease-specific outcomes across multiple medical domains. This approach ensures that treatments and interventions are tailored to the individual needs of each patient.
  • To empower patients and enhance engagement: UNIFIED supports proactive symptom management, enhances treatment commitment, and promotes informed participation in care, contributing to improved quality of life and long-term health outcomes.

The consortium is led by Erasmus University Rotterdam and composed of 40 partners representing academia, healthcare industry, health authorities, clinicians, and patient representatives. 

Partners 

Academic, Clinical, and Public Health Institutions  

1. Erasmus University Rotterdam (NL)

2. Medical University of Vienna (AT)

3. University of Amsterdam (NL)

4. Hochschule Neubrandenburg (DE)

5. University of Calgary (CA)

6. University of Twente (NL)

7. Catholic University of Leuven (BE)

8. University of Milan (IT)

9. Jagiellonian University (PL)

10. Princess Máxima Center (NL)

11. University Medical Centre Utrecht (NL)

12. European Institute of Oncology (IT)

13. Helsinki University Hospital (FI)

14. Andalusian Public Foundation Progress and Health (ES)

15. The Hospital for Sick Children (CA)

16. H2O Pan-European Health Outcome Observatory (DK)

17. PanCare (NL)

18. European Academy of Neurology (AT)  

19. Fondazione Policlinico Universitario Agostino Gemelli IRCCS (IT)

Patient/Citizen Organisations  

20. European Patients’ Forum (BE)  

21. Cassie and Friends: A Society for Children with Juvenile Arthritis and Other Rheumatic Diseases (CA)

22. Childhood Cancer International Europe (NL)  

23. The European Coalition for People living with Obesity (IE)  

24. Parkinson’s Europe (BE)  

Industry and Small & Medium Enterprises  

25. Pfizer Inc (US)  

26. AbbVie Inc (US)  

27. AstraZeneca AB (SE)  

28. F. Hoffmann-La Roche AG (CH)  

29. Janssen Biologics BV (NL)  

30. Mölnlycke Health Care AB (SE)  

31. Novartis Pharma AG (CH)  

32. Novo Nordisk A/S (DK)  

33. Siemens Healthineers AG (DE)

34. UCB Biopharma (BE)  

35. IQVIA Solutions Belgium (BE)  

36. Amgen (BE)  

37. GenAIz (CA)  

38. John Snow Labs Inc (US)  

39. Collaborate Project Management (DE)  

40. Promptly – Software Solutions for Health Measures SA (PT)