Unifying Framework for Patient-centred Clinical-study Endpoints derived from Digital Health Technologies

Motivation: Failing to incorporate patient perspectives in healthcare decisions leads to sub-optimal care. Despite increasing emphasis from industry and policy-makers this is not yet common practice. Main objectives: UNIFIED is a public-private partnership involving universities, industry, patient groups, medical centres, HTA bodies, and clinical guideline organisations. It is designed to generate a UNIFIED Framework for obtaining a robust view of a health intervention’s full benefits to patients via (i) integrating three key data types: patient preference information, clinical outcome assessments, and digital health technology (DHT)-derived measures, and (ii) determining what patients consider minimum clinically important difference. Leveraging cutting-edge AI, particularly Foundation Models, UNIFIED integrates these diverse patient-centred data types reliably, while employing advanced safeguards. UNIFIED uses a structured, interactive, and multimethod approach, fostering synergy between academic expertise and fast experience in pharmaceutical and MedTech industry. Validation of the initial framework will occur through well-aligned complementary use cases in five medical domains across Europe and Canada and an adoption approach for patients, caregivers, clinicians, industry, regulatory/HTA/reimbursement bodies.Main deliverables: A robust evidence- and consensus-based UNIFIED Framework with recommendations for integrating patient-centred clinical-study endpoints. The framework will provide clear, actionable guidance for timely and effective use of patient-centred, DHT-derived data as clinical endpoints.Expected long-term impact: Through its evidence- and consensus-based framework and recommendations, UNIFIED empowers patients, caregivers, clinicians, industry, regulatory/HTA/reimbursement bodies to make patient-centred healthcare decisions. This will drive measurable improvements across the healthcare ecosystem, benefitting patients, caregivers, clinicians, industry, regulatory/HTA/reimbursement bodies, and society. Ultimately, UNIFIED will enhance patient-centred care by ensuring healthcare decisions reflect true value to patients, thus improving patient outcomes, while ensuring healthcare’s long-term effectiveness and economic sustainability.