The Trial Coordination Board (TCB)

A forum for multilateral discussions and recommendations on the strategic development of the adaptive platform trials.

The Trial Coordination Board (TCB) gathers the main actors, playing a role in the successful implementation and development of the European adaptive platform trials (APTs) in infectious diseases with pandemic potential.

Led by: NIPH

 

Main mission

It aims to ensure collaboration and cooperation between these European APTs, and to create and maintain a constructive dialogue with regulatory bodies, policy makers and global infectious diseases trials. Through this dialogue, the TCB provides recommendations for the strengthening of the European platform trials and identifies opportunities for synergies amongst them.

Initially developed to support the COVID19 APTs and then those covering MPöx the scope now includes any infectious disease with epidemic or pandemic potential.

The TCB originated as part of a shared Work Package between the EU funded projects EU RESPONSE, RECOVER; ECRAID-Prime and VACCELERATE. The TCB (NIPH) is also a beneficiary in the MPX RESPONSE project. 

The TCB is divided into two pillars: the therapeutic pillar (Tx) and the vaccine pillar (Vx). Some meetings are Joint (Tx and Vx).

Composition

  • The coordinators of the RECOVER (project closed 2023), EU-RESPONSE, ECRAID-Prime, VACCELERATE and MPX RESPONSE projects
  • The principal investigators of 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 TCB Tx pillar include principal investigators of the RECOVERY, PRINCIPLE, PANORAMIC, STRIVE and ANTICOV trials
  • The TCB Vx pillar principal investigators of the COMCOV, COMCOV-2 and COMCOV-3, Preg-CoV, MonkeyVax and other European vaccine trials on an ad hoc basis
  • 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 does it work?

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.

TCB collaboration

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