EffecTrial: "Fostering Pragmatic Comparative-Effectiveness Trials in Non-communicable Diseases"

The objectives of the call are:

• Support randomized, interventional and pragmatic comparative effectiveness studies (Investigator-Initiated Clinical Studies, IICS) in several countries.
• Encourage and enable cross-national collaboration between clinical/public health research teams (from hospitals/public health, healthcare institutions and other healthcare organizations) conducting multi-country comparative effectiveness IICS.

Proposals should address all the 4 following points:

• Be a pragmatic comparative effectiveness trial, designed as randomised interventional trial.
• Compare the use of currently approved healthcare interventions either to each other or to the current standard of care.
• They shall consider healthcare interventions 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 nutrition and/or lifestyle interventions, surgery, prognosis methods, use of medical devices, eHealth and digital interventions and other health interventions.
• These interventions shall have high public relevance only in the fields of these specific diseases or conditions (that are of equal importance):
  • Cardiovascular diseases
  • Metabolic disorders
  • Nutrition and lifestyle-related diseases
  • Non-communicable respiratory diseases

The focus of the multi-country 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 other related comorbidities.

Only consortia whose research question includes at least the use of one nutrition and/or lifestyle interventions are eligible for funding from BMBF/DLR-PT.

Out of scope

• Studies in other medical areas different from the ones mentioned above (cardiovascular diseases, metabolic disorders, nutrition and lifestyle-related diseases and non-communicable respiratory diseases).
• Particularly, those clinical trials that are focused on rare diseases, cancer and/or infectious diseases are out of the scope of this call, even if these diseases are 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.
• Basic biomedical research
• Development of a new healthcare intervention
• Phase I and phase II studies
• Placebo randomized controlled trials

Timeline and eligibility criteria:

• 28^th of January 2025 – pre-proposal submission
• 17^th of June 2025 –proposal submission
• initial duration of the clinical studies will be 48 months
• min of 3 funded partners and a maximum of 5 participating countries
• Max. 3 non-funded partners (collaborators)
• German funding in 1 project max. 350,000 EUR (including 20 % overhead); 500,000 EUR if sponsor

Participating countries:

Austria, Czech Republic, France, Germany, Ireland, Israel, Italy, Latvia, Lithuania, Norway, Poland, Slovakia, Spain

Further information:

https://era4health.eu/calls/effectrial2025.php

Contact at EPC

© TU Dresden

Project Manager

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Mr Dr. Stefan Schuldt

ERA-Nets, BMBF Complementary measures

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European Project Center

European Project Center

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