The Trial Coordination Board (TCB) gathers the main actors, playing a role in the successful implementation and development of the European COVID-19 adaptive platform trials (APT). It aims to ensure collaboration and cooperation between the European COVID-19 APTs, and to create and maintain a constructive dialogue with regulatory bodies, policy makers and global COVID-19 trials. Through this dialogue, the TCB provides recommendations for the strengthening of the European COVID-19 platform trials and identifies opportunities for synergies between trials.
Furthermore, the TCB looks to address other outbreaks as they arise including the MPöx and any future epidemic.
The TCB is now divided into two pillars: the therapeutic pillar and the vaccine pillar.
The core members of the therapeutic pillar of the TCB include:
- The coordinators of the RECOVER, EU-RESPONSE and ECRAID-Prime projects
- The principal investigators of DisCoVeRy, EU-SolidAct, ECRAID-Prime, and REMAP-CAP in Europe
- Representatives from the European Commission (DGs RTD, SANTE, HERA) and the European Health and Digital Executive Agency (HaDEA)
- The principal investigators of the RECOVERY, PRINCIPLE, Panoramic, MANTICO-2, STRIVE and ANTICOV trials
The core members of the vaccine pillar of the TCB include:
- The coordinators of the VACCELERATE project
- The principal investigators of the VACCELERATE trials: EU-COVAT-1-AGED, EU-COVAT-2-BOOSTAVAC, EU-COVPT-1 CoVacc
- COMCOV, COMCOV-2 and COMCOV-3
The extended TCB includes:
- Policy makers such as the WHO and the European Center for Disease Prevention and Control (ECDC)
- Representatives from key initiatives and programmes such as CEPI and the COVID-19 Therapeutics Accelerator
- Regulators and representatives from ethics committees including: the EMA, the Heads of Medicines Agencies Clinical Trials Facilitation and Coordination Group (CTFG), the European Network for Health Technology Assessment (EUnetHTA) and European Network of Research Ethics Committees (EUREC)
- The pharmaceutical industry, represented through the EFPIA
- Scientific experts in the fields of preclinical research, design and implementation of adaptive platform trials and vaccine trials
How it works
The core missions of the TCB include the identification and recommendation of new platform trials when needed, for therapeutics and prophylaxis and the coordinated dialogue between trials to avoid duplications and maximize synergies.
The TCB now constitutes two pillars, the TCB Therapeutic pillar (Tx) and the TCB Vaccine pillar (Vx). Some meetings are “Joint” where topics are of overarching relevance. Meetings run approximately twice a month in fixed slots. Agendas and consolidated summaries are organized by the TCB secretariat, situated at NIPH, with input from the wider research landscape. Topics have over the past years been focused on COVID-19, but are now reflecting the scope of the involved research networks and, hence, also discussing other pathogens with outbreak potential.
Collaboration through the TCB
Since its creation the TCB has provided space for networking; fostering synergies between trials and research initiatives and identifying areas of collective interest for focused efforts. It has been a forum for discussion on the following topics:
- Evolution of the ongoing COVID-19 platform trials in Europe and abroad and identification of opportunities for complementarity and collaboration.
- Expectations from European regulatory bodies for adaptive platform trials aiming for registration of new therapeutics.
- State of the art of preclinical models for COVID-19 and opportunities for closing gaps between preclinical and clinical research.
- Expectations of the pharmaceutical and biopharmaceutical industry on adaptive platform trials and opportunities for public/private collaboration.
- Existing capacities and needs for pan-European research efforts on outpatient COVID-19 clinical research.
- Discussions on other emerging outbreaks and research gaps
-Opportunities for alignment between research preparedness initiatives in the EU and beyond
For any questions regarding the TCB please contact us.