2027 – IICS4all 2027 (ERA4Health partnership)

Multi-national Investigator-Initiated Clinical Studies in Cardiovascular, Autoimmune, Metabolic and Non-Communicable Respiratory Diseases, including underrepresented Populations 

Together with the ERA4Health partnership (Fostering a European Research Area for Health Research), KCE Trials is happy to announce the upcoming “IICS4all 2027”. This call will be dedicated to funding multi-national, comparative effectiveness or drug repurposing Investigator-Initiated Clinical Studies (IICS) in Cardiovascular, Autoimmune, Metabolic, and Non-Communicable Respiratory diseases including underrepresented populations. 

Deadline for submission is 14 January 2027.

An online info session will be held on 10 November 2026 from from 14:30 to16:30 CET. Please register here https://era4health.eu/calls/iics4all2027.php

Prior to the submitting of the proposal, applicants are required 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 cross-cutting sponsorship costs (the deadline for the first contact with ECRIN is 30 November 2026). See Additional budget.
 

The ERA4Health partnership

The ERA4Health partnership currently brings together 67 partners from 30 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. After its contribution to the Trials4Health 2026 call, KCE will contribute to the upcoming IICS4all 2027 call, with a budget of 1,500,000 Euro. 

Scope of the IICS4all 2027 call 

The aim of the call is to support pragmatic, phase III, randomised controlled, multi-national interventional Investigator-Initiated Clinical Studies (IICS) 

1. that are designed as following study types:
   • comparative-effectiveness studies and/or

   • drug repurposing studies of off-patent drugs

     Applicants can make use of existing cohorts, e.g. for designing Trials within Cohorts (TwiCs).

2. that have a high public relevance in the fields of these specific diseases or conditions (that are of equal importance):
   1. Cardiovascular diseases
   2. Metabolic disorders*
   3. Autoimmune diseases* 

   4. Non-communicable respiratory diseases

      The multi-national Investigator-Initiated Clinical Studies should primarily address at least one of the abovementioned principal diseases/conditions, although the proposals can also address several of the mentioned diseases/conditions and/or in combination with related comorbidities.

3. that ensure inclusivity and diversity in the study population and also include sex/gender sensitive, age-specific or other diversity-related aspects, if reasonable.

    *Proposals focusing on type 1 diabetes should contact the Breakthrough T1D funding organisation, which can fund partners from different countries, also from countries not participating in the call.

   Out of scope

• Clinical studies conducted for direct commercial purposes.
• For drug repurposing studies: a drug still on patent in one of the participating countries. This criterion also applies to biological medicinal products and biosimilars. 
• Phase I and Phase II studies: Studies in which a treatment is used in humans for the first time, or which are aimed exclusively at assessing tolerability, safety or dose determination
• Proposals focused on observational studies, non-interventional cohort studies, implementation studies, translational/clinical approval studies, creation of large databases, systematic reviews and meta-analysis. Non-randomised studies. 
• Studies in other medical areas which are not mentioned above (cardiovascular diseases, metabolic disorders, autoimmune diseases and non-communicable respiratory diseases). Particularly, those clinical studies 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. 
• Basic biomedical research and research involving animals or animal tissue.
• Development of a new healthcare intervention.
• Medicinal products without marketing authorization in Europe and in other countries outside the EU/EEA involved in the respective consortium. Medical devices without CE marking.
• 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.
• Topics excluded from Horizon Europe: research which aims at human cloning for reproductive purposes, modifying the genetic heritage of human beings which could make such modifications heritable, creating human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer, or leading to the destruction of human embryos (for example, for obtaining stem cells).

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 14 January 2027. 

There will be a two-step submission and evaluation procedure for joint applications. In addition, the full proposal review process will be complemented by a rebuttal phase including a dedicated feasibility assessment. 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 on the dedicated electronic submission system PT-Outline by the Coordinator Investigator*. 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

If you are interested in this call and are looking for potential consortium partners, please have a look at the partner search tool PartFinder that is available on the ERA4Health website (filter by choosing the call name “ERA4Health JTC9 IICS4all”).

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 Belgian 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 are available. These templates are 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 2026 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 TrialsIICS4all 2027 template - Letter of commitment for Belgian Sponsor version 1.0, 27 October 2026
-    KCE TrialsIICS4all 2027 template - Letter of commitment for entity offering support version 1.0, 27 October 2026 
-    KCE TrialsIICS4all 2027 - Research Agreement for Belgian Sponsor version 1.0 27 October 2026

Documents for studies with international sponsor
-    KCE TrialsIICS4all 2027 template - Letter of commitment for International Sponsor version 1.0, 27 October 2026 
-    KCE TrialsIICS4all 2027 template - Letter of commitment for BCC version 1.0, 27 October 2026
-    KCE TrialsIICS4all 2027 template - Letter of commitment for entity offering support version 1.0, 27 October 2026
-    KCE TrialsIICS4all 2027 template - Research Agreement for BCC version 1.0 27 October 2026

More information:
https://era4health.eu/calls/iics4all2027.php