2026 –Trials4Health investigator-initiated call (ERA4HEALTH partnership)

06.11.2025. Together with the partnership  ‘Fostering a European Research Area for Health Research’ (ERA4Health), KCE Trials is happy to open the “Trials4Health 2026” call. 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 is 27 January, 2026.

A webinar Infoday will be held on November 13th, from 14.30 to 16.30 for researchers interested in the call (see more information on https://era4health.eu/calls/trials4health2026.php). 

Prior to the submitting of the proposal, applicants are strongly advised to contact KCE Trials to clarify the specific requirements of this call.

Potential sponsors in Belgium need to act quickly to request additional EU funding to cover their sponsorship costs (the deadline for the first contact with ECRIN is 30 November 2025). See Additional budget.

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, 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.
3. In case of comparative effectiveness trials, these must compare 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 antibody-based autoimmune diseases and/or 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. However, 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 of 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/). 

Deadline and time schedule  

The deadline for submission at ERA-level is 27 January, 2026.

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 at trials@kce.fgov.be. Documents required at national level must be sent by e-mail to KCE within the same deadline (see below Additional requirements for Belgium).

Participating countries/regions and respective funding organisations

Who can submit at Belgian level  

Each partner of a joint transnational proposal must apply to its relevant national/regional funding organisation.
To be considered eligible, the Belgian partner, whether acting as Sponsor or Belgian Coordinating Centre (BCC), must be a Belgian non-profit institution or research organisation with proven expertise in conducting non-commercial multicentre clinical trials. 

Specifically:
-    If the partner acts as sponsor, it must have successfully completed a KCE Trials sponsor capacity assessment.
-    If the partner acts as BCC, it must, depending on the tasks it is committed to conduct, demonstrate sufficient operational support from  a clinical trial centre (CTC) or equivalent.

The Belgian partner must secure a formal commitment to participate in the trial from at least one recruiting centre in each Belgian region (Flanders, Wallonia, and Brussels). Exceptions to this requirement will be allowed only if centralized care hampers the participation of one recruiting site in each region. This must be clearly justified within the proposal.

Additional requirements for Belgium

In addition to the ERA procedures and conditions outlined in the Trials4Health Call text, Belgian applicants must also comply with specific KCE Trials requirements, as reflected in our research agreement templates.

Dedicated Trials4Health templates for Belgian Sponsors and BCCs will be made available shortly. These templates will be based on the existing KCE Research Agreement templates and will incorporate the essential KCE funding principles applicable to this Call, including:

-    The obligation to collect the national registry number of Belgian study participants
-    Additional compliance, reporting and dissemination requirements at national level
-    The obligation to share research data
-    Provisions for the potential re-use of research results

While these Trials4Health templates will be adapted to accommodate the ERA funding conditions, they will remain closely aligned with the above mentioned core KCE funding principles.

ADDITIONAL BUDGET to cover sponsor costs:

 An additional budget of a maximum up to 15% of the total budget requested to the national/regional funders can be requested for covering the conduction of cross-cutting management activities (i.e. clinical study management activities at consortium level) such as trial authorizations, drug, safety and data management under the responsibility of the  coordinating investigator and his/her legal entity through collaboration with ECRIN (www.ecrin.org). This additional budget will be directly allocated to ECRIN to perform cross-cutting trial management activities. 
To request this additional budget in the pre-proposal, the consortium shall closely collaborate with ECRIN during the pre-proposal phase to define the details of the service provision (either directly performed by ECRIN or by an entity subcontracted by ECRIN, in the case that ECRIN cannot provide these services). To guarantee that the collaboration is well established and with enough time, the consortium must inform ECRIN representatives as soon as possible and before this deadline: 30th November 2025 that they are preparing an application. 
Additional information can be found in the call text. 
 

Links and downloads

General KCE Trials policies

-    General principles for the declaration of interests by applicants and the  management of (potential) conflicts of interest in KCE-funded clinical trials
-    KCE Trials key conditions for data sharing and intellectual property management 
-    KCE Trials policy on Research Transparency
 

Documents for studies with sponsor in Belgium

-    KCE Trials4Health 2026 template - Letter of commitment for Belgian Sponsor version 1.0, 06 November 2025
-    KCE Trials4Health 2026 template - Letter of commitment for entity offering support version 1.0, 06 November 2025 
-    KCE Trials4Health 2026 - Research Agreement for Belgian Sponsor version 1.0 18 December 2025
 

Documents for studies with international sponsor

-    KCE Trials4Health 2026 template - Letter of commitment for International Sponsor version 1.0, 06.11.2025 
-    KCE Trials4Health 2026 template - Letter of commitment for BCC version 1.0, 06 November 2025
-    KCE Trials4Health 2026 template - Letter of commitment for entity offering support version 1.0, 06 November 2025
-    KCE Trials4Health 2026 template - Research Agreement for BCC version 1.0 18 December 2025

 

More information:

https://era4health.eu/calls/trials4health2026.php