Title: Coordinating Mechanism for Cohorts and Trials

GA Number: 101136531

Background:

COMECT is an EU-Funded Coordination and Support Action (CSA), designed to link-up multiple existing European coordination initiatives to encourage synergy and reduce overlap. The two coordination initiatives, Trial Coordination Board (TCB) and Cohort Coordination Board (CCB) will be aligned into one single, coherent coordination mechanism for Adaptive Platform Trials (APTs) and/or Cohort Studies (CSs). These boards will be formed into a Coordination Board, alongside an Outbreak Response Board (ORB), developed during the first phases of the project, to liaise with the two others and activate timely action. Also running alongside the Coordination Board will be the Joint Access and Advisory Mechanism (JAAM), which was established in response to the COVID-19 pandemic research needs to ensure optimal coordination of trials.

COMECT’s activities will liaise with all key stakeholders of the IDs research landscape going beyond the research institutions and articulating with policymakers (e.g., EMA, CTCG, ECDC), funders (e.g., BE-READY, GloPID-R, IHI, EDCTP3, DG RTD, HERA), industry (EFPIA), and patient organisations. The project structure of CoMeCT includes Working Groups on Exploration (mapping), Harmonisation and Innovation, and Communication. The working groups will feedback to inform agendas and discussions in the Coordination Board, and help shape research directions and consolidate ideas and innovation.

Objectives:

1. To expand on European coordination mechanisms and supportive processes and policies, to facilitate coordination of research and innovation actions, exchange of good practices, and coherent stakeholder engagement across APTs and CSs.

2. To expand the Joint Access Advisory Mechanism (JAAM), supporting coordination through the independent scientific assessment of therapeutic compounds and vaccines and providing recommendations for the most appropriate APTs and vaccine trials.

3. To develop and maintain an overview of relevant APTs and CSs, and facilitate engagement with external stakeholder networks and organisations

4. To enable GDPR-compliant cross-study identification, assessment, and reuse of participant level data from European APTs and CSs. To share operational best practices. To monitor progress of clinical research methodologies and data analytical approaches.

5. To ensure coherent communications and visualise coordinated stakeholder engagement and dialogue across APTs and CS and coordinating networks and projects

6. To monitor and report progress to COMECT’s objectives, ensure compliance with contractual obligations (EC Grant Agreement and consortium agreement) and develop a sustainability plan to ensure ongoing coordinating mechanism.

UNIVR activities:

Within this project, the ID-CARE team at the University of Verona will continue the management of the CCB as it has since the beginning, acting as secretariat for the meetings, drafting key reports and supporting the visibility of EU cohort research on the global stage.

UNIVR will also chair the Working Group (WG) on Exploration which focusses on project objective 3 To develop and maintain an overview of relevant APTs and CSs, and facilitate engagement with external stakeholder networks and organisations. Central to this working group is the development and maintenance of an up-to-date Central Data Repository (CDR) of APT and CS.

The continuous mapping of this group will facilitate the participation of the relevant projects to the TCB and CCB, information flow to the EC, facilitate bilateral exchange between networks and relevant initiatives and bring these initiatives to the agenda of the Coordination Board.