ERA4Health Partnership 2026 Joint Transnational Call – Trials4Health

Please take in note that 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 take into account 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. The clinical design should be appropriate and justified. 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 (see definition), 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 consider existing, approved healthcare interventions (see definition) 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.
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, therefore only off-patent drug repurposing trials are allowed.
5. 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.

Beyond the research topics, the requirements and recommendations should be considered (check the Call text for further information).

Please note that additional conditions might apply at national level.

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.
• 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).

General conditions for application

The duration of the clinical studies will be 48 months.

Any IICS must clearly demonstrate the potential health, economic, and/or policy impacts, as well as the added value of transnational collaboration.

Applicants shall not apply to different calls for the same research activities. Double funding is not allowed. Proposals should follow the principles of Responsible Research and Innovation (RRI).

Consortia must show how they will engage with and address the relevant social, political, equity, environmental or cultural dimensions of the proposed research. The proposal template and ERA4Health RRI Guidelines  further elaborate on how RRI dimensions can be approached (see our recommendation in the guidelines for applicants).

IICS supported by ERA4Health must respect fundamental ethical principles. Applicants must fill an ethical grid as part of their proposal and describe any potential ethical aspects of the work to be carried out, and how the clinical study will fulfil applicable requirements in institutional, national and European Union legislation (including the ethical standards and guidelines of Horizon 2020/ Horizon Europe  ). All funded partners must respect the fundamental principle of research integrity — as set out in the European Code of Conduct for Research Integrity . IICS involving human embryonic stem cells (hESC) or human embryos (hE) may not start without prior ethics review carried out by the European Commission and subsequent decision of the Horizon Europe Programme Committee .

The individual partners of the joint applications should be complementary in their expertise, and the proposed work should pursue a high implementation potential for the benefit of end-users/patients/citizens.
Furthermore, additional aspects need to be considered in the application:

• The design of the clinical study must be appropriate to answer the research question (population, sample collection, statistical power, statistical analysis, interpretation, relevant models for hypothesis validation) must be well justified and should be part of the proposal.
• Strategies for recruitment, retention, assessment, and analysis must be included. The clinical study design and objectives should take into consideration the population that would be needed to reach the objective of the study.
• Gender equality as well as inclusiveness of the diversity of the population in the recruitment.
• Involvement of patient/patients’ representatives and other relevant users in the co-creation and implementation of the tasks

Call Timeline