Multi-national Investigator-Initiated Clinical Studies in Cardiovascular, Autoimmune, Metabolic, and Non-Communicable Respiratory Diseases, including Underrepresented Populations (IICS4all 2027)

Identifier: HORIZON-HLTH-2022-DISEASE-03-01 Status: Open Submission procedure: multiple cut-off Opening date: 2026-10-27 Deadline: 2027-01-14 Budget: €29,573,700 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): • Cardiovascular diseases • Metabolic disorders • Autoimmune diseases • 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. 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 requirements Beyond the research topics, several additional requirements and recommendations should be considered by the applicants, including approaches to Responsible Research and Innovation (RRI). Please consult the Call text document and the Guidelines for applicants document for further information, including the RRI guidelines and specific national/regional restrictions. Submission: There will be a two-step submission and evaluation procedure for joint applications, i.e. pre-proposals, with invitation of successful consortia to submit a full proposal. In addition, the full proposal review process will be complemented by a rebuttal phase including a dedicated feasibility assessment of the coordinating investigator and the representative of the sponsor. For both steps, proposals (in English) shall be prepared by the consortium partners following the ERA4Health template (included in the ERA4Health website) and must be submitted by the coordinator via the electronic submission system tool PT-Outline (LINK). Eligibility criteria: Applicants must demonstrate that the research teams contains the necessary breadth and depth of expertise in all methodological areas required to deliver the proposed study. Principal Investigators should demonstrate experience and expertise in the conduct and delivery of clinical trials. Size of the consortium: The number of participants and their research contribution should be appropriate for the aims of IICS and be reasonably balanced in terms of international participation. Each IICS should represent the critical mass to achieve ambitious scientific goals and should clearly demonstrate an added value from working together. The project must be a transnational project involving eligible research partners from a minimum of 3 (three) and a maximum of 5 (five) different countries participating in the call. In addition, in each consortium at least two eligible partners (independent legal entities) must be from different EU Member States or Horizon Europe Associated Countries participating in the call. A maximum of 3 (three) collaborators per consortium is allowed. Collaborators are self-funded partners. Please check the call text for further conditions that apply to the composition of consortia and for collaborators. Each study consortium must nominate a clinical study coordinator among its partners (NOT a collaborator). The clinical study coordinator cannot be a commercial enterprise or for-profit organisation. Each Principal Investigator can submit only 1 (one) pre-proposal as coordinator or as simple partner...