Insights

The European Medicines Agency has released draft guidance on the conduct of clinical trials during public health emergencies, outlining a more risk-proportionate and flexible framework for both new and ongoing studies. The document emphasizes that participant rights, safety and data integrity must remain central, even when urgent public health needs require faster regulatory action.

Among the key points, EMA highlights the importance of prioritizing well-designed clinical trials over fragmented or isolated studies, encouraging coordination across the EU to generate robust evidence more efficiently. The guidance also addresses practical adaptations such as remote informed consent, remote safety monitoring, direct shipment of investigational products to participants, remote source data verification, and the transfer of participants to alternative sites when needed.

For sponsors, the message is clear: preparedness, risk management and early interaction with regulators will be essential to maintain trial continuity during future emergencies. The guidance also confirms that substantial modifications directly linked to a public health emergency may benefit from expedited assessment.

RPN will provide any further update and is available to provide full support for clinical trial activities.