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

Objective

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.

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-JU-IHI-2024-08-two-stage

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Coordinator

ERASMUS UNIVERSITEIT ROTTERDAM
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 3 079 810,00
Address
BURGEMEESTER OUDLAAN 50
3062 PA Rotterdam
Netherlands

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Activity type
Higher or Secondary Education Establishments
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 3 079 810,00

Participants (39)

Partners (11)

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