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Stress the importance of clinical studies today—and urge for formal approach to managing the pandemic and addressing specific public health needs more sustainably.
It's an ill wind that brings no benefit to anyone, as the saying goes—and the ill wind that COVID-19 has represented for everyone has, nonetheless, brought some benefits to the profile of the healthcare sector as a major player in protecting and restoring citizens' health, and to the significance of clinical trials in particular.
As a European Commission document released this week remarks,1 "Due to the increasing need of developing new vaccines and therapeutics, clinical trials have become more important than ever."
The document takes the form of a series of recommendations as to how the European Union and its member states should tackle the ongoing COVID pandemic and prepare against its recrudescence. And in a lengthy section on vaccine development, it states that large, multi-national clinical trials "are regarded as the best approach to generate adequate clinical evidence in the shortest time for regulatory decisions."
More important than ever. But still not good enough. What the experience to date with pandemic has shown, the Commission document observes, is that there is a need for a faster and more robust procedure for a coordinated approval of multi-national clinical trials by member states. This is the way, it urges, to avoid fragmentation when small, mono-national trials are competing for the same resources and patient populations.
This is the reasoning behind the creation of two European clinical trial networks under the EU research program, Horizon 2020. To enable large-scale multi-national trials addressing the specific public health needs for COVID in Europe, one now exists for therapeutics, and one for vaccines. In addition, an advisory mechanism on joint access supports more efficient use of resources between trials, and avoids duplication of efforts. The vaccine trial network includes public health focused vaccine trials in the elderly, in the general adult population, and in children (known as EU-COVAT-1 AGED, EU-COVAT-2 BOOSTAVAC and EU-COVPT-1 CoVacc). Moreover, in January, the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agency launched ACT EU, aimed at bringing together clinical research stakeholders to enable bigger, faster, and better clinical trials.
The swift approval of large-scale clinical trials in the EU is also part of the EU Strategy on COVID-19 Therapeutics, and a joint action was launched to implement the fast-tracked assessment and approval of multinational trials in this area. The competence of EMA's emergency task force, which was set up during the pandemic, was also recently extended to include support for cooperation between sponsors to enable large-scale platform trials in public health emergencies.
At international level, European regulators are also contributing to the ongoing revision of the guideline on Good Clinical Practice of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. They are also supporting the work within the International Coalition of Medicines Regulatory Authorities to contribute to international acceptability of large-scale platform trials to address health emergencies.
The initiatives and actions that the EU now plans to take include strengthening the national capacity in EU countries to undertake research and contribute to multi-country clinical trials during a crisis, with priority to the timely implementation of European multi-state trials. At the same time, the EU will monitor the full implementation of the clinical trials regulation—which has among its aims the improvement of efficiency of trials in the EU. And specifically in relation to COVID, it will support coordination and harmonization of the conduct and oversight of the EU-funded COVID therapeutic platform trials, and implement a joint action for fast-tracked approval of COVID therapeutic trials and the development of a harmonized procedure for expedited and coordinated member-state assessment of clinical trial applications in case of future emergencies.
Now the hope must be that the ill wind of Covid will itself abate—baffled and tamed by new waves of protective measures. And in the best of all possible worlds, clinical trials, meanwhile, will have won many admirers and much respect.