The Partnership "Fostering a European Research Area for Health" (ERA4Health) aims at establishing a flexible and effective coordination between funding organisations in the European Research Area (ERA) in priority areas addressing European Public Health Needs.

This Partnership brings the opportunity to increase European transnational collaborative research funding by creating a funding body for joint programming. Under this umbrella, ERA4Health is glad to pre-announce the launch of a first Joint Transnational Call (JTC) in multi-country Investigator-Initiated Clinical Studies (IICS) on "Fostering Pragmatic Comparative-Effectiveness Trials in Non-communicable Diseases" (EffecTrial).

The aims of the call are:

- to support randomised, interventional and pragmatic comparative-effectiveness multicountry Investigator-Initiated Clinical Studies (IICS).

- to encourage and enable transnational collaboration between clinical/public health research teams (from hospital/ public health, healthcare settings and other healthcare organisations) that conduct comparative-effectiveness multi-country IICS.

Proposals should address all the 4 following points:

1) Be a pragmatic comparative effectiveness trials, designed as randomised interventional trials.

2) Compare the use of currently approved healthcare interventions either to each other or to the current standard of care.

3) 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. 

4) These interventionsshall have high public relevance only in the fields of these specific diseases or conditions (that are of equal importance):

o Cardiovascular diseases

o Metabolic disorders

o Nutrition and lifestyle-related diseases

o Non-communicable respiratory diseases

Call Timeline

· Proposals must clearly demonstrate the potential health and/or economic impact(s) as well as the added-value of transnational clinical collaboration.

· Proposals must include an early involvement of 'end users' (e.g. patients, care providers, healthcare professionals, etc) in the design of the study (integrating patient valued outcomes) and in the research process. This is to ensure acceptability of the healthcare intervention and utility of the studies' knowledge for healthcare decision making. Patient organisations or other end-users can participate as partners (if eligible for funding by a national/regional funding organisation), as collaborators (participation with own budget) or as part of an advisory board.

· Special consideration must be given to fulfilling all ethical requirements (See ethical requirements and clearance section in the call documents, including reference to Reference to EU Regulation 2021/695 and ethical self-assessment).

· The consortia shall ensure the management of research data according to FAIR data principles and in compliance with the General Data Protection Regulation (GDPR).

· The proposed research shall consider sex and gender aspects, whenever applicable.

· Partners in the consortia, especially the coordinating PI, should have a proven track record in delivery of clinical trials to ensure the feasibility of the clinical trial.

· The consortia should consider the gender balance in their composition and to balance the responsibilities between them.

· Additionally, proposals should take into account the diversity of health systems in different regions of Europe to allow large-scale uptake.

· The consortia are requested to ensure inclusiveness aspects in patient recruitment (minorities, ethnical aspects...), to include underrepresented and vulnerable populations that could be specifically relevant in a certain medical area and consider issues of particular relevance for the target population, for example, gender specificities, age, multimorbidity, complex chronic conditions, polypharmacy, substance misuse, vaccine efficacy, compliance, and diseases with high societal burden.

· For the chosen population, clinical and safety parameters, as well as health and socioeconomic outcomes (e.g. quality of life, patient mortality, (co)morbidity, costs, and performance of the health system) should be assessed. Consider using new instruments and methods for determining the burden of disease and for evaluating the effects of the interventions. Low-cost innovations should also be considered.

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