2025/10 - Multi-country Investigator Initiated Clinical Trials in Cardiovascular, Autoimmune and Metabolic diseases (Trials4Health 2026 - ERA4Health partnership)

Preliminary announcement:

Together with the partnership  ‘Fostering a European Research Area for Health Research’ (ERA4Health), KCE Trials is happy to announce the “Trials4Health 2026” call will open on 6 November, 2025. This call provides funding for multi-country, comparative effectiveness or drug repurposing Investigator-Initiated Clinical Studies (IICS) in Cardiovascular, Autoimmune and Metabolic diseases. Deadline for submission will be 27 January, 2026.

A webinar Infoday will be held on 13 November, 2025 for researchers interested in the  call. 

The ERA4Health partnership

The ERA4Health partnership currently brings together 37 partners from 24 countries and aims at establishing a flexible and effective coordination between funding organisations in the European Research Area (ERA) in priority areas addressing European Public Health Needs. This Partnership brings the opportunity to increase European transnational collaborative research funding by creating a funding body for joint programming. More information on ERA4Health and their previous calls can be found on https://era4health.eu/

In June 2025, KCE joined the ERA4Health Partnership to fund multi-country IICS that are pragmatic and non-commercial randomized controlled clinical trials. KCE will contribute with a budget of 2 000 000 euro in the Trials4Health 2026 call. 

Scope of the Trials4Health 2026 call 

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

1. The proposed study needs to be a pragmatic comparative effectiveness trial and/or a drug repurposing trial, designed as Phase III randomised interventional trial. Cluster randomisation could be considered in the clinical trial design if justified.  
2. In case of comparative effectiveness trials, 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.
3. In case of comparative effectiveness trials, it has to be considered 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, reproduceable 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.
4. 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.
5. These interventions shall have high public relevance in at least one of these specific diseases or conditions (that are of equal importance):
   1. Cardiovascular diseases
   2. Metabolic disorders
   3. Autoimmune diseases (including not only antibody-based autoimmune diseases but also other Immune-mediated inflammatory diseases)  

Out of scope:

• Clinical studies conducted for direct commercial purposes.
• Studies in other medical areas different from the ones mentioned above (cardiovascular diseases, metabolic disorders and autoimmune diseases).
• Particularly, those clinical trials that are focused on cancer are out of the scope of this call, even if this is studied with one of the eligible diseases/conditions.
• Proposals focused on observational studies, cohort studies, translational/clinical approval studies, creation of large databases, systematic reviews and meta-analysis.
• Non-randomised studies.
• Basic biomedical research and research involving animals or animal tissue.
• Development of a new healthcare intervention.
• Drugs without marketing authorization in Europe, medical devices without CE mark. Off-label use that is well established in usual care is accepted.
• Phase I and phase II studies
• In comparative-effectiveness studies, the use of placebo will only be allowed for blinding the interventions that will be compared. Otherwise, the use of placebo in those studies will be out of the scope. In the case of drug repurposing trials, this exclusion would not apply and these studies could include placebo, albeit it would not be mandatory to include it.

Additional information on requirements and recommendations can be found at the ERA4Health website (https://era4health.eu/). 

Time schedule

There will be a two-step submission and evaluation procedure for joint applications. The full proposal review process will be complemented by an online interview of the coordinating investigator and a representative of the sponsor, and a rebuttal stage. For both submission steps, one joint proposal document (in English) shall be prepared by the partners of a joint transnational proposal and must be submitted via the dedicated electronic submission system PT-Outline by the project coordinator. The two-step application process will have the following timetable:

^{*Please note that your pre-proposal needs to be submitted BOTH on the electronic submission system PT-Outline AND
 by sending a copy of your pre-proposal to KCE trials by e-mail.} 

^{Participating countries/regions and respective funding organisations}

More information will soon be available online:

https://era4health.eu/

^{Please note: The content of the call described in this pre-announcement is indicative and may be subject to changes and is not legally binding. Interested applicants are encouraged to initiate scientific contacts with potential project consortium partners for applications.}