The European Medicines Agency (EMA) has released a workshop report outlining recommendations to enhance clinical trials during public health emergencies in the EU. The report suggests actions to address challenges faced during events like the COVID-19 pandemic, focusing on improving regulatory processes for large trials and establishing a funding framework.
It highlights the need for larger, faster trials across multiple countries, involving better coordination among regulators and ethics committees, accelerated assessment, and use of the EU Clinical Trials Information System. The report also suggests expanding the role of EMA's Emergency Task Force (ETF) to include voluntary involvement of ethics committees. The proposed actions aim to create a conducive research environment and will guide the EU's efforts in improving clinical trials during emergencies.
The Accelerating Clinical Trials in the EU (ACT EU) initiative will drive implementation of trial approvals, while funding mechanisms will be discussed in conjunction with the European Commission and Member States.
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