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


Aims of the call

The aims of the call are:

  • to support randomised, interventional and pragmatic comparative-effectiveness multi-country 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.
EffecTrial2025call

Proposals should address all the 4 following points :

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

Beyond the research topics, the requirements and recommendations should be considered (check the Call text for further information).

Please note that additional conditions might apply at national level.

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

General conditions for application

The initial duration of the clinical studies will be 48 months.

Any IICS 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 the relevant social, political, equity, environmental or cultural dimensions of the proposed research. The pre-proposal template and the ERA4Health RRI Guidelines further elaborate on how RRI dimensions can be approached (check the Guidelines for Applicants for more information).

IICS supported by ERA4Health must respect fundamental ethical principles. Applicants must fill an ethical grid and describe any potential ethical aspects of the work to be carried out, and how the clinical study will fulfil applicable requirements in institutional, national and European Union legislation (including the ethical standards and guidelines of Horizon 2020/Europe ).

The individual partners of the joint applications should be complementary in their expertise and the proposed work should pursue a high implementation potential to benefit of end-users/patients/citizens.

Furthermore, additional aspects need to be considered in the application:

  • The design of the clinical study (sample collection, statistical power, interpretation, relevant models for hypothesis validation) must be well justified and should be part of the proposal.
  • Strategies for recruitment, retention, assessment, and analysis must be included. The clinical study design and objectives should take into consideration the population that would be needed to reach the objective of the study.
  • Gender equality as well as inclusiveness of the diversity of the population in the recruitment.
  • Involvement of patient/patients' representatives and other relevant users in the co-creation and implementation of the tasks.

Please take in note that clinical studies conducted for direct commercial purposes are excluded from support by the ERA4Health programme.


Call Timeline

Call Pre-announcement 21 October 2024
Publication of EffectTrial call 20 November 2024
Webinar Infoday November 27th, 2024 14:30 – 16:30 CET
Deadline for pre-proposal submission 28 January 2025
Communication of the results of the pre-proposal assessment (invitation for full proposal) 15 April, 2025
Deadline for the submission of invited Full-proposals 17 June, 2025
Rebuttal stage 25 August – 5 September, 2025
Communication of the funding decisions to the applicants End of October, 2025
Expected project start (subject to national procedures) January – May 2026

Further information

Joint Call Secretariat (JCS) - Astrid Valencia Quiñónez and Sara García-Rodríguez EffecTrial@isciii.es

Information & Application

Call Text  
Guideline for Applicants
Pre-Proposal Application form
Recording ERA4Health 2nd webinar Pragmatic Comparative-Effectiveness Randomized Trials: Real-World Evidence for Better Health Decisions

Participating countries/regions and respective funding organisations

FWF AT  AT FONDS ZUR FÖRDERUNG DER WISSENSCHAFTLICHEN FORSCHUNG (FWF)
MZCR CZ  MINISTRY OF HEALTH (MZCR)
BMBF DE  BUNDES MINISTERIUM FÜR BILDUNG UND FORSCHUNG (BMBF) Represented by DLR Project Management Agency (DLR-PT)
DLR DE  DEUTSCHES ZENTRUM FUR LUFT – UND RAUMFAHRT EV (DLR)
CSCJA ES  CONSEJERÍA DE SALUD Y CONSUMO DE LA JUNTA DE ANDALUCÍA (CSCJA)
ISCIII ES  INSTITUTO DE SALUD CARLOS III (ISCIII)
Fr-MoH FR  MINISTÈRE DE LA SANTÉ ET DE L’ACCÈS AUX SOINS (Fr-MoH)
HRB IE  THE HEALTH RESEARCH BOARD (HRB)
CSO-MOH IL  MINISTRY OF HEALTH (CSO-MOH)
IT-MOH IT  MINISTERO DELLA SALUTE (IT-MOH)
LMT LT  LIETUVOS MOKSLO TARYBA (LMT)
LCS LV  LATVIJAS ZINATNES PADOME (LCS)
RCN NO  NORGES FORSKNINGSRAD (RCN)
NCBR PL  NARODOWE CENTRUM BADAN I ROZWOJU (NCBR)
SAS SK  SLOVENSKÁ AKADÉMIA VIED (SAS)

Events related to the call

2024-10-21 Pre-announcement of the Fostering Pragmatic Comparative-Effectiveness Trials in Non-communicable Diseases (EffecTrial) call