Paving the way towards coordinated clinical trials in public health emergencies in the EU
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Human
Clinical trials
EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set up and conducted in the European Union (EU) during public health emergencies. The actions presented in the report aim to holistically address the barriers and challenges experienced during the COVID-19 pandemic and the outbreak of mpox disease in setting up adequately sized clinical trials across multiple Member States that enable rapid gathering of sufficient, high-quality evidence to support robust decision-making by health authorities across the EU.
The workshop was organised by EMA’s Emergency Task Force (ETF) and the European Commission (EC) on 9 June 2023, with participation from national competent authorities (NCAs), ethics committees representatives and academic sponsors.
The workshop discussions emphasised the need for larger studies across several European countries, speedier recruitment and delivery of conclusive results with accelerated timelines during a public health emergency. Proposed actions focus on two areas:
- the processing and regulatory approval of large, multinational clinical trials in the EU during public health emergencies. This includes e.g. improving coordination between regulators and ethic committees within and across Member States, speeding up assessment and authorisation of clinical trial applications, exploring flexibilities in the implementation of the Clinical Trials Regulation, facilitating the use of the EU Clinical Trials Information System (CTIS);
- the framework for funding and efficient allocation of resources for clinical trials during emergencies in the EU, including the establishment of a Coordinating Committee to support prioritisation of trials, improved mechanisms to identify and rank promising compounds, mobilising EU and Member State funding mechanisms, and measures to help speed up contracting of clinical trial sites.
According to the recommendations, ETF’s essential role of providing scientific advice, reviews, and supporting large clinical trials in emergency situations, should be expanded to also include concerned ethics committees on a voluntary basis to discuss and coordinate clinical trials protocols.
The workshop participants emphasised the need to make Europe a better place for research. The proposed actions will be taken into account by the EC, EMA and the Member States in establishing a concrete roadmap for improved clinical trials during public health emergencies in the EU. The work on approvals of clinical trials in public health emergencies will be taken forward by the Accelerating Clinical Trials in the EU (ACT EU) initiative, the EU collaboration between the EC, Heads of Medicines Agencies (HMA) and EMA that seeks to transform how clinical trials are initiated, designed, and run. The framework for funding will be specifically discussed with the EC and Member States in the context of current efforts to improve the coordination for funded clinical research in the EU and with international actors.