Introduction: The EffecTrial 2025 call aims to support randomized, interventional, and pragmatic comparative-effectiveness multi-country Investigator-Initiated Clinical Studies (IICS). It encourages and enables transnational collaboration between clinical/public health research teams from hospitals, public health, healthcare settings, and other healthcare organizations.

General Description: This call focuses on:

• Conducting pragmatic comparative effectiveness trials designed as randomized interventional trials.
• Comparing the use of currently approved healthcare interventions either to each other or to the current standard of care.
• Considering healthcare interventions which could include diagnostic, screening, prevention, and treatment interventions, both pharmacological and non-pharmacological (e.g., nutrition, lifestyle interventions, surgery, prognosis methods, medical devices, eHealth, and digital interventions).

Objectives:

• Address high public relevance in the fields of cardiovascular diseases, metabolic disorders, nutrition and lifestyle-related diseases, and non-communicable respiratory diseases.
• Enable transnational collaboration to leverage diverse patient populations and data sets.

Approaches:

• Mechanistic/experimental research.
• Identification and validation of biomarkers of organs/systems/disorders crosstalk (including epigenetics biomarkers).
• Generation of digital models of disease(s) to study disease-disease or disease-drug interactions.

Exclusions:

• Studies in medical areas different from cardiovascular diseases, metabolic disorders, nutrition and lifestyle-related diseases, and non-communicable respiratory diseases.
• Clinical trials focused on rare diseases, cancer, and/or infectious diseases.
• Observational studies, cohort studies, translational/clinical approval studies, creation of large databases, systematic reviews, and meta-analysis.
• Basic biomedical research, development of new healthcare interventions, Phase I and Phase II studies, and placebo randomized controlled trials.

Project Duration: 48 months.

Call Phases:

• Pre-proposal phase.
• Full-proposal phase.

General Eligibility:

• Joint research proposals must be submitted by consortia involving at least three partners from three different EU Member States or Associated Countries.
• Consortia must include partners from academia, clinical/public health sector, and private for-profit or non-profit partners.
• Each consortium must nominate one project coordinator among the principal investigators.
• Maximum number of partners per consortium: 6 (pre-proposal stage), 7 (full-proposal stage with widening option).

Conditions:

• Proposals must clearly demonstrate the potential health, economic, and/or policy impacts, as well as the added value of transnational collaboration.
• Proposals should follow the principles of Responsible Research and Innovation (RRI).
• Consortia must show how they will engage with and address relevant social, political, equity, environmental, or cultural dimensions of the proposed research.
• Clinical studies conducted for direct commercial purposes are excluded from support by the ERA4Health programme.

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