Nov 24, 2025

ERA4Health Call 2026 – Trials4Health – out now!

Trials4Health: "Multi-country Investigator-Initiated Clinical Trials in Cardiovascular, Autoimmune and Metabolic diseases”

The aims of the call are:

to support randomised, interventional and pragmatic comparative-effectiveness multi-country Investigator-Initiated Clinical Studies (IICS) that are designed as pragmatic comparative-effectiveness studies and/or drug repurposing studies.

to encourage and enable transnational collaboration between clinical/public health research teams (from hospital/ public health, healthcare settings and other healthcare organisations) that conduct comparative-effectiveness multi-country IICS, either comparative-effectiveness or drug repurposing studies.

Clinical studies conducted for direct commercial purposes are excluded from support by the ERA4Health programme. In the case of the involvement of any private for-profit entity, it is needed that the consortia duly justify their role in the proposal and that there is no commercial purpose or benefit.

Proposals should address all the following points that apply according to the selected clinical trial design:

The proposed study needs to be a pragmatic comparative effectiveness trial and/or a drug repurposing trial, designed as Phase III randomised interventional trial. The clinical design should be appropriate and justified. Cluster randomisation could be considered in the clinical trial design if justified.
In case of comparative effectiveness trials, these must compare the use of currently approved or existing healthcare interventions, used in clinical practice in Europe, either to each other or to the current standard of care.
In case of comparative effectiveness trials, these must consider existing, approved healthcare interventions which could include but would not be limited to: diagnostic, screening, prevention and treatment interventions. The interventions can be pharmacological as well as non-pharmacological procedures like well-defined, reproducible and targeted nutritional and lifestyle interventions, surgery, prognosis methods, use of medical devices, nano and advanced health technologies, eHealth and digital interventions and other health interventions.
In case of drug repurposing trials, the aim shall be to explore a new indication of an approved off-patent medication. Given that this call is supported by public funding, clinical studies with a commercial purpose are excluded, therefore only off-patent drug repurposing trials are allowed.
These interventions shall have high public relevance in at least one of these specific diseases or conditions (that are of equal importance):
- Cardiovascular diseases
- Metabolic disorders
- Autoimmune diseases (including antibody-based autoimmune diseases and/or also other Immune-mediated inflammatory diseases)

The focus of the multi-country Investigator-Initiated Clinical Studies is cardiovascular, metabolic or autoimmune disorders as primary causes of illness. Proposals may focus on a single cardiovascular, metabolic or autoimmune disease, or they may explore these conditions in combination with comorbidities.

Timeline and eligibility criteria:

27^th of January 2026 – pre-proposal submission
17^th of June 2026 –proposal submission
duration of the clinical studies will be 48 months
consortia with min of 3 funded partners and a maximum of 5 participating countries
Max. 3 non-funded partners (collaborators)
German funding in 1 project max. 500,000 EUR (including 20 % overhead); 750,000 EUR if sponsor

Participating countries:

Austria, Belgium, Czech Republic, France, Germany, Italy, Latvia, Lithuania, Norway, Poland, Romania, Slovakia, Sweden, Spain, Türkiye, United Kingdom, United States