New IHI public–private partnership ‘UNIFIED’ launched to advance the use of patient-centered endpoints in healthcare evaluation 

A new €27 million public–private partnership, led by Erasmus University Rotterdam and Pfizer, has launched to develop an internationally aligned framework for applying patient-centered endpoints in clinical research, regulatory review, and health technology assessment (HTA). 

UNIFIED (Unifying Framework for Patient-Centred Clinical-study Endpoints Derived from Digital Health Technologies) has been created to help close the persistent gap between traditional clinical outcomes and the aspects of health that patients consider most meaningful. The five-year initiative, funded through the Horizon Europe Innovative Health Initiative (IHI) Joint Undertaking, brings together 40 partners across academia, clinical practice, patient organizations, and industry from Europe, North America, and Canada. 

The project responds to a long-standing challenge in clinical research and evaluation. As Esther de Bekker-Grob, Professor of Health Economics & Health Preferences, Erasmus University Rotterdam, and Jorien Veldwijk, Associate professor, Erasmus School of Health Policy & Management, explained:  

“Clinical trials often focus on outcomes that measure the safety and effectiveness of medical interventions. While these are critically important, they do not always reflect what patients genuinely value.” 

They noted that when patient perspectives are not incorporated into key decisions, “the results are suboptimal care and inefficient use of resources,” which can lead to “reduced treatment adherence, less effective self-management, low acceptance of treatments, poorer health outcomes, and increased inequality within society,” as well as wasted resources and higher system costs. 

UNIFIED aims to address this through a harmonized framework and consensus-based recommendations that guide the integration of patient preference information, clinical outcome assessments, and digital health technology-derived measures. The project will also advance methods for determining the minimal clinically important difference in patient-centered endpoints, based on what patients consider meaningful. 

The team stated that: 

“By developing medical interventions that align with what patients need, we can improve health outcomes, reduce inefficiencies in care and product development, and ultimately lower the economic burden of chronic diseases.” 

To ensure broad applicability, the project will generate evidence across five diverse use cases: pediatric radiation oncology, lung cancer, Parkinson’s disease, obesity, and juvenile idiopathic arthritis. These areas have been selected to test the applicability of patient-centered endpoints across both rare and common conditions, and across pediatric and adult populations. 

“We see this as a breakthrough project. By combining the expertise of public and private institutions, we hope to close the gap that patients, clinicians, industry, academics, and policymakers have long faced. It’s ambitious, it’s necessary, and it directly addresses what patients have been seeking,” said de Bekker-Grob. 

Patient involvement is embedded as a structural component of the project. The team describes this as “an opportunity that we actively embrace,” supported by input from a Patient Advisory Group and supported by training, workshops, and co-creation activities. This approach is intended to ensure that patient perspectives are systematically integrated into project outputs. 

The project’s collaborative structure includes ongoing engagement with regulators, HTA bodies, clinicians, and patient organizations to ensure the framework is both practical and usable. As noted by Bianca Pop, European Patients’ Forum Project Officer: 

“This project will deliver not only an evidence-based framework but also one that is practical, sustainable, and accessible… ensuring that patient perspectives guide every stage of the work and healthcare outcomes mirror patients’ daily realities and priorities.”