Putting the Patient Voice at the Centre of Healthcare Decisions
Healthcare decisions shape people’s lives. They influence which treatments are developed, approved, reimbursed, and ultimately made available to patients. Yet too often, the outcomes used in clinical studies do not fully reflect what matters most to patients in their everyday lives.
UNIFIED exists to change that.
UNIFIED stands for Unifying Framework for Patient Centred Clinical Study Endpoints Derived from Digital Health Technologies. The project brings together partners from academia, clinicians, patient organisations, industry, health technology assessment bodies, and regulators across Europe, Canada, and the United States.
Our shared ambition is clear. Clinical evidence should reflect what truly matters to patients.
WHAT UNIFIED AIMS TO ACHIEVE
UNIFIED is developing the UNIFIED Framework, a harmonised and internationally aligned approach to integrating patient centred endpoints into clinical studies and healthcare decision making.
The Framework focuses on three key components:
Patient preferences information
Clinical outcome assessments
Digital health technology-derived measures
By bringing these elements together in a structured and evidence based way, UNIFIED aims to support more holistic clinical and economic evaluation of medical products and technologies.
This means helping ensure that healthcare decisions are informed not only by traditional clinical indicators, but also by outcomes that capture how patients feel, function, and experience treatment in daily life.
FROM RESEARCH TO REAL WORLD
APPLICATION
UNIFIED will test and refine the framework through use cases in five medical areas:
Paediatric Radiation Oncology
Lung Cancer
Parkinson's Disease
Obesity
Juvenile Idiopathic Arthritis
These diverse areas allow the project to explore how patient centred endpoints can be applied across different conditions, age groups, and healthcare contexts.
The goal is to deliver practical guidance and consensus based recommendations that can be used by researchers, companies, regulators, HTA bodies, and clinicians.
A GLOBAL PUBLIC PRIVATE PARTNERSHIP
UNIFIED is funded under the Innovative Health Initiative, a Horizon Europe public private partnership that brings together the European Union and industry to tackle complex health challenges.
The project is coordinated by Erasmus University Rotterdam as Coordinator and Public Lead, in collaboration with Pfizer as Industry Lead, and a consortium of 40 partners. Together, the consortium combines methodological expertise, clinical knowledge, digital innovation, regulatory insight, and lived experience.
WHY UNIFIED MATTERS
Calls for patient involvement in healthcare are not new. What is new is the opportunity to systematically integrate patient perspectives into the way clinical evidence is generated and evaluated.
Digital health technologies make it possible to capture outcomes in new ways. Advances in patient preference research help clarify what patients value most. Policy momentum across Europe supports more patient centred approaches.
UNIFIED builds on this momentum.
By developing a shared framework and clear recommendations, the project aims to ensure that measures reflecting what matters to patients are no longer the exception. They become part of standard practice in healthcare decision making.
Because healthcare should start and end with the patient.
