Multinational Investigator-Initiated Clinical Studies in Cardiovascular, Autoimmune, Metabolic and Non-Communicable Respiratory Diseases, including Underrepresented Populations
Aim of the call
The aim of the call is to support pragmatic, phase III, randomised controlled, multi-national interventional Investigator-Initiated Clinical Studies that have a high public relevance and that ensure inclusivity and diversity in the study population and also include sex/gender-sensitive, age-specific or other diversity-related aspects, if reasonable.
Scope
- Research areas:
- Cardiovascular diseases
- Metabolic disorders
- Autoimmune diseases
- Non-communicable respiratory diseases
- Study types:
- Comparative-effectiveness trials
- Drug repurposing trials (off-patent drugs)
- Design:
- Multi-national (min. 3 countries) and multicentric
- Pragmatic
- Randomised
- Maximum study duration of 48 months
- Out of scope:
- Cancer research
- Commercial trials
- Fundamental or pre-clinical research
- Observational studies, implementation studies, cohort studies, translational research, meta-analyses, etc.
- Development of a new healthcare intervention, or use of drugs without marketing authorization in Europe or medical device without CE mark.
Timelines
- Call open: 27 October 2026
- Deadline for registration with KCE: 30 November 2026
- Deadline pre-proposal submission: 14 January 2027
- Deadline full proposal (for selected applicants): 14 June 2027
- Funding decision: End of October 2027
- Expected project start: January – May 2028
Infosession (online)
ERA4Health will organise an online information session on Tuesday, 10 November 2026, from 14:30 to 16:30 CET. Registration is available via the ERA4Health website with this link.
Support of HIRUZ
For more information and support, please contact the Clinical Trial Unit of Health, Innovation and Research Institute (HIRUZ) via hiruz.ctu@uzgent.be or contact Hélène De Naeyer (Helene.DeNaeyer@uzgent.be, 09/332.05.05) or Joke Tommelein (Joke.Tommelein@uzgent.be 09/332.09.08) directly.
More information