ERA4HEALTH Partnership

Features

The ERA4HEALTH partnership’s joint transnational call has been published : Joint Transnational Call for Investigator-Initiated Clinical Studies (JTC IICS) – 2026 Trials4Health 2026: Multi-country Investigator-Initiated Clinical Trials in Cardiovascular, Autoimmune, and Metabolic Diseases

The objectives of this call for proposals are to support multicenter, randomized, investigator-initiated clinical studies focused on the comparative effectiveness and/or repurposing of drugs, with a clearly justified and transparent design. In addition, it seeks to foster transnational collaboration among clinical and public health teams conducting this type of trial.

The call for proposals is co-funded by the European Union and has an estimated total budget of more than 35 million euros. The Carlos III Health Institute (ISCIII) is participating as the national funding agency, with a budget of 2,400,000 euros to fund 3–4 proposals.

Requirements

Proposals should take into account the following points, which apply depending on the selected clinical trial design:

1. The proposed study must be a pragmatic comparative effectiveness trial and/or a drug repurposing trial, designed as a Phase III randomized interventional trial. The clinical design should be appropriate and justified. Cluster randomization could be considered in the clinical trial design if justified.
2. In the case of comparative effectiveness trials, these must compare the use of currently approved or existing healthcare interventions (see definition), as used in clinical practice in Europe, either with one another or with the current standard of care.
3. In the case of comparative effectiveness trials, these must consider existing, approved healthcare interventions(see definition), which may include, but are not limited to: diagnostic, screening, prevention, and treatment interventions. The interventions may include both pharmacological and non-pharmacological procedures, such as well-defined, reproducible, and targeted nutritional and lifestyle interventions, surgery, prognostic methods, the use of medical devices, nano- and advanced health technologies, eHealth and digital interventions, and other health interventions.
4. In the case of drug repurposing trials,the goal is to explore a new indication for an approved, off-patent medication. Since this call is supported by public funding, clinical studies with a commercial purpose are excluded; therefore, only off-patent drug repurposing trials are permitted.
5. These interventions must be highly relevant to the public in relation to at least one of these specific diseases or conditions ( which are of equal importance):
   • Cardiovascular Diseases
   • Metabolic disorders
   • Autoimmune diseases (including antibody-mediated autoimmune diseases and/or other immune-mediated inflammatory diseases).

The focus of the multi-country Investigator-Initiated Clinical Studies is on 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.

In addition to the research topics, the requirements and recommendations should be taken into account (see the Call text for further information).

Submission deadline.

The following table lists the different dates: