Description
The call is launched by the ERA4Health partnership, a European initiative for collaborative funding in health research. This call seeks to support randomised, interventional, multi‑country Investigator‑Initiated Clinical Studies (IICS) that are either pragmatic comparative‑effectiveness trials or drug‑repurposing trials, with the aim of improving patient care across Europe. Projects should be non‑commercial, and any private or for‑profit participant must have a clearly justified non-commercial role. The call encourages transnational collaboration among clinical and public‑health research teams from hospitals, healthcare settings or other health organisations. The proposals should address high‑public‑health‑relevance diseases, specifically cardiovascular diseases, metabolic disorders, or autoimmune/immune‑mediated inflammatory diseases. The study design must be appropriate (e.g. Phase III, randomised; cluster randomisation allowed if justified) and full justification must be given. Duration of funded studies is up to 48 months.

Objective: to generate robust clinical evidence on existing health interventions (or repurposed drugs) with high relevance for cardiovascular, metabolic or autoimmune conditions, enhancing health outcomes and fostering collaborative European clinical research.

Budget

• Total budget for the call: €32,190,000. 

• Funding per project will depend on national/regional funders. For example, for Andalusian institutions: as coordinator up to €1,000,000 (via ISCIII) or €250,000 (via CSCJA); as partner up to €750,000 or €125,000 respectively.

• The study must be a multi‑country Investigator‑Initiated Clinical Study (IICS).

• The design must be a pragmatic comparative‑effectiveness trial and/or a drug‑repurposing trial, Phase III, randomised (cluster‑randomised acceptable if justified).

• For comparative‑effectiveness trials: must compare existing, approved healthcare interventions used in clinical practice in Europe; these can be pharmacological or non‑pharmacological (e.g. diagnostics, prevention, treatment, surgery, nutritional/lifestyle interventions, medical devices, eHealth, advanced health technologies).

• For drug‑repurposing trials: only off‑patent, approved drugs may be used for a new indication; new investigational drugs are excluded.

• Studies must focus on at least one of: cardiovascular diseases, metabolic disorders, or autoimmune/immune‑mediated inflammatory diseases; comorbidities may be included.

• Commercial purpose is excluded: proposals must demonstrate no direct commercial interest.

• Observational studies, cohort studies, translational/basic research, animal studies, development of new interventions, Phase I/II trials, meta-analyses, systematic reviews, or development of new devices without CE mark are out of scope.

• Proposals must demonstrate potential health, economic and/or policy impact; show added value of transnational collaboration; comply with ethical standards, research integrity, and include plan for recruitment, diversity, inclusion, patient/user involvement, and a clear statistical and methodological plan.

• Responsible Research and Innovation (RRI) principles should be followed.

• Note: Additional national/regional eligibility criteria may apply (for each country participating).

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