2027 – IICS4all 2027 (ERA4Health partnership)

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

Pre-announcement

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. This is a pre-announcement. The call is scheduled for publication on 27 October 2026.  
An online infosession will be held on 10 November 2026 for interested researchers. 

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/gendersensitive, 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 mark.
• 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/). 

Time schedule  

There will be a two-step submission and evaluation procedure for joint applications. In addition, the full proposal review process will be complementedby 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. 

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”).

More information will soon be available online:

IICS4all 2027 | ERA4Health Pre-announcement

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.