COordination MEchanism for Cohorts and Trials

The overall goal of COMECT is to coordinate activities across Europe'Äôs strategic adaptive platform trials (APTs) and cohort studies (CS) on infectious diseases (IDs) with epidemic or pandemic potential, by overseeing and facilitating dialogue, sharing of good practices, promoting collaboration and coordination across studies and providing updated information on initiatives and innovation in ID clinical research. COMECT will build on and strengthen existing networks and infrastructure. These include EU-funded coordination mechanisms and networks, namely the Trial Coordination Board (TCB), Joint Access Advisory Mechanism (JAAM), the Cohort Coordination Board (CCB), and the ECRAID Coordinating Comittee. COMECT will develop a visible, well-defined coordination mechanism to highlight Europe's capacity and competence as an attractive base for clinical research. 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 coordination through independent scientific assessment of compounds/vaccines and recommendations for APTs 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. COMECT will quickly adapt coordination efforts to a changing research landscape and to new ID threats. COMECT will operate in close collaboration with other emergency preparedness mechanisms, such as HERA, EMA, GLOPiD-R and the European Pandemic Preparedness Partnership.