EMA publishes clinical trial plan for public health emergencies
The European Medicines Agency (EMA) outlined that the aim of the workshop was to address the barriers and challenges that had been experienced during the COVID-19 pandemic.
Specifically, this related to setting up adequately sized clinical trials across multiple Member States that allow for rapid and high-quality evidence to support decision-making by health authorities across the European Union (EU).
The workshop brought together national competent authorities (NCAs), ethics committees representatives, and academic sponsors, with their contributions being compiled in the published report.
The report opens with the major difficulties the region faced when the pandemic emerged to set up clinical trials. It concludes that the ‘fragmented clinical research landscape’ and competition for the same resources and patient populations across the region was a major detriment to research.
In particular, this caused obstacles to the rapid generation of conclusive evidence on the safety and efficacy of vaccines and treatments. In addition, the difficulty of activating networks of clinical trials across Member States and in accessing timely funding were some of the other issues that were discussed.
The report offers two areas where action could be taken to avoid these issues, and other difficulties that emerged during the pandemic: processing and regulatory approval of large, multinational clinical trials; and providing a framework for funding and efficient allocation of resources for clinical trials.
On the first point, the suggestions included improving coordination between regulators and ethic committees in the region; speeding up assessment and authorization of clinical trial applications; exploring flexibilities in the implementation of clinical trial regulation; and facilitating the use of the EU clinical trials information system.
The latter point called for the establishment of a coordinating committee to support prioritization of trials; improved mechanisms to identify and rank promising therapeutic compounds; mobilizing EU and member states funding mechanisms; and measures to help speed up contracting of clinical trial sites.
According to the EMA, the next step for applying the input from the workshop is to create a roadmap for improving clinical trials during public health emergencies in the EU. This will be taken forward by the Accelerating Clinical Trials in the EU initiative, which is formed of the European Commission (EC), Heads of Medicines Agencies, and the EMA, with its mandate to refine how clinical trials are initiated, designed, and run.
