TCB

Trial Coordination Board

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.

 

Composition

 The core of the TCB is composed of:

  • The coordinators of the RECOVER and EU-RESPONSE projects
  • The principal investigators of DisCoVeRy, EU-SolidAct and REMAP-CAP in Europe
  • Representatives from the European Commission and the European Health and Digital Executive Agency (HaDEA)
  • The principal investigators of the RECOVERY, PRINCIPLE and AMMURAVID trials

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 Techniology 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
  • Representatives from large-scale COVID-19 trials abroad, including the ACTIV-3/TICO trial and the ANTICOV trial

How it works 

The core TCB meets on a biweekly basis, with members for the extended TCB being invited to meetings on an ad hoc basis. 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. 

Through the TCB an additional level of collaboration has been established between the Data Safety and Monitoring Boards (DSMBs) of the APTs. The DSMB chairs of DisCoVeRy, EU-SolidAct, REMAP-CAP, RECOVERY and PRINCIPLE, have established a sustained communication channel to share key information on safety signals when testing the same drugs or drugs with similar mechanisms of action, to optimize patient safety.

 

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.

 

For any questions regarding the TCB please contact us.