CoMeCT Project

The Coordination Mechanism for Cohorts and Trials.

Our Mission

To strengthen Europe's clinical research preparedness and response to infectious disease outbreaks with epidemic potential by facilitating strategic and scientific coordination of adaptive platform trials (APTs) and cohort studies (CSs).

We unite the established EU-funded coordination efforts that have arisen since the onset of COVID-19 pandemic to ensure optimal coordination across Europe and beyond.

We endeavour to strike a balance between ensuring the autonomy of APTs and CSs, respecting their internal governance and legal requirements, while recognizing the imperative need for cross-study European coordination.

The implementation of a transparent and well-defined Coordination Mechanism, as proposed by CoMeCT, will play a pivotal role in showcasing Europe's capacity for clinical research and fostering long-term collaboration within the wider research ecosystem.

CoMeCT is funded by the European Union (Horizon Europe programme) under grant agreement n° 101136531, and will run for three years (2023-2026). During this time period, we will work to ensure sustainability of our activities. This project involves 7 partners (INSERM, Ecraid, ECRIN, NIPH, PENTA, UNIVR, and University of Cologne) and is coordinated by the Norwegian Institute of Public Health (NIPH).

 


 

Why coordinate efforts?

The lessons learned from the COVID-19 pandemic have shown us that without such coordination, there are several risks resulting in:

  • Fragmentation, in other words, multiple small trials studying the same interventions in similar populations, resulting in inconclusive outcomes due to insufficient patient data or samples. This leads to wasted resources.
  • Increased risk of studies without sufficient statistical power to generate high quality clinical evidence.
  • Gaps in the exploration of specific patient groups or intervention types at various disease stages.
  • Lack or delayed adoption of improved study designs, methods, and practices.
  • Limited visibility of individual APTs and CSs to broader stakeholders, causing a mismatch between research focus, findings, and public health policies.
  • Insufficient consideration of the interventions entering trials at various phases.

Moreover, as the number of APTs and CSs is growing, there is an increasing need for ongoing mapping and prospective coordination across these clinical studies.

The Coordination Mechanism for Cohorts and Trials will, by design, create dedicated venues for exchange with all the stakeholders in order to avoid these risks and operate to ensure that the results discussed are widely disseminated for a maximum impact.

Furthermore, this will offer invaluable support to overburdened healthcare systems in their quest for harmonized approaches to patient care and timely implementation of public health measures.

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CoMeCT in hand

CoMeCT will deliver:

1) An expanded, combined European Coordination Mechanism that will work on harmonizing research initiatives, exchange of good practices, and stakeholder engagement across ID clinical studies in outbreaks and during inter-epidemic phases;

2) A strengthened JAAM to support APT coordination through independent scientific assessment of compounds/vaccines and recommendations to evaluate the new compound in new or adapted platform trials;

3) The mapping of stakeholders and their respective activities relevant to APTs and CS;

4) A harmonised approach cross-study identification, assessment, and reuse of participant-level data from European APTs and CS;

5) Coherent communications and stakeholder engagement across all activities;

6) A sustainability plan for the continuation of activities beyond the funding period.