European policymakers recognize the benefits of COVID-related trials

Stress the importance of clinical studies today and urge a formal approach to managing the pandemic and responding in a more sustainable way to specific public health needs.

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 nevertheless brought benefits to the profile of the health sector as as a major player in protecting and restoring the health of citizens, and the importance of clinical trials in particular.

As a European Commission document published this week notes,1 “Due to the growing need to develop new vaccines and therapeutics, clinical trials have become more important than ever.”

The document takes the form of a series of recommendations on how the European Union and its Member States should combat the ongoing COVID pandemic and prepare for its upsurge. And in a lengthy section on vaccine development, it says large, multinational clinical trials “are considered the best approach to generate adequate clinical evidence in the shortest possible time for regulatory decisions.”

More important than ever. But still not good enough. What experience to date with the pandemic has shown, observes the Commission document, is that there is a need for a faster and more robust procedure for coordinated approval of multinational clinical trials by Member States. This is the way, he insists, to avoid fragmentation when small, mononational trials compete for the same resources and patient populations.

This is the rationale behind the creation of two European Clinical Trials Networks under the EU research programme, Horizon 2020. To enable large-scale multinational trials addressing specific public health needs in the COVID in Europe, there is now one for therapeutics, and one for vaccines. In addition, a joint access advisory mechanism promotes more efficient use of resources between trials and avoids duplication of effort. The Vaccine Trials Network includes public health-focused vaccine trials in the elderly, general adult population, and children (referred to as EU-COVAT-1 AGED, EU-COVAT-2 BOOSTAVAC and EU-COVPT -1 CoVacc). Additionally, in January, the European Commission, the European Medicines Agency (EMA) and the Heads of the Medicines Agency launched ACT EU, aiming to bring together clinical research stakeholders to enable larger clinical trials, faster and of better quality.

Rapid approval of large-scale clinical trials in the EU is also part of the EU strategy on COVID-19 therapeutics, and joint action has been launched to implement the assessment and expedited approval of multinational trials in this area. The remit of EMA’s emergency task force, which was set up during the pandemic, has also recently been extended to include support for cooperation between sponsors to enable large-scale platform trials in public health emergencies.

At the international level, European regulators are also contributing to the ongoing revision of the Good Clinical Practice Guideline of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. They also support the work within the International Coalition of Medicines Regulators to contribute to the international acceptability of large-scale platform trials to address health emergencies.

Initiatives and actions the EU now plans to take include strengthening the national capacity of EU countries to undertake research and contribute to multi-country clinical trials during a crisis, prioritizing the timely implementation of European multi-state trials. At the same time, the EU will monitor the full implementation of the Clinical Trials Regulation, one of the objectives of which is to improve the efficiency of trials in the EU. And more specifically with regard to COVID, it will support the coordination and harmonization of the conduct and monitoring of EU-funded COVID Therapeutic Platform trials, and implement joint action for accelerated approval of COVID therapeutic trials and the development of a harmonized procedure for accelerated and coordinated assessment by Member States of clinical trial applications in the event of a future emergency.

Now the hope must be that the ill winds of Covid will die down on their own – 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 a lot of respect.



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