GLOPID-R

02/10/2121

Strength in working together: One year of European and international clinical trial coordination

An EU-wide network of COVID-19 therapeutic adaptive platform trials was set up early in the summer of 2020. The first meeting of the Trial Coordination Board (TCB), including the coordinators and sponsors of the REMAP-CAP, EU-SolidAct and DisCoVeRy trials, was held in September. What started as an internal coordination mechanism between two EU-funded projects is now a successful forum for trusted dialogue between large-scale European and international COVID-19 therapeutic trials.

Strength in working together: One year of European and international clinical trial coordination

During the pandemic, it became clear early on that the clinical trial landscape for investigating COVID-19 therapeutics was fragmented, with small trials struggling to recruit enough patients for robust results. Large-scale, multi-center clinical trials were needed to produce the necessary scientific evidence on the effectiveness of these treatments. The European Commission responded to this need by supporting three adaptive platform trials in Europe: REMAP-CAP, EU-SolidAct and DisCoVeRy, and it set up the TCB.

These three trials are currently recruiting patients from over 200 clinical sites in around 15 different countries across Europe and have delivered important results for treatment options for COVID-19 patients. The TCB ensures alignment and complementarity among the trials. The group has developed a Joint Advisory Access Mechanism (JAAM) as a common access point for these platform trials, and assesses requests from researchers or industry looking to use the trials to test specific drugs. Discussions between the trial organizers and developers of new medicines are ongoing.

To support coordination and exchange beyond the three EU-funded trials, meetings are also attended by representatives from other European and international trials, including Italian-based AMMURAVID, UK-based RECOVERY and PRINCIPLE, African-based ANTICOV, as well as the WHO Solidarity trial and US-based ACTIV-3.

The TCB is engaged in active dialogue with WHO and is establishing a collaborative initiative with industry to enforce alignment of adaptive platform trials and address current and post-pandemic needs. As a funder of the EU-wide adaptive platform trials at the core of the TCB, the Commission regularly participates in these meetings. By helping to prevent duplication, this investigator-led board increases the return on investment in COVID-19 therapeutics.

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The GloPID-R Secretariat is a project which receives funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 874667.