Clinical trials during public health emergencies

The Accelerating Clinical Trials in the European Union (“EU”) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (“PHEs”). The guidance is currently open for public consultation until April 30, 2026.

This is the first guidance reflecting the EU’s current legislative framework and incorporating the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use developed in response to the COVID-19 pandemic.

Scope and objective

The guidance is intended to apply both to clinical trials initiated in response to a PHE and to trials addressing other needs that may continue during a crisis, provided participant safety and data integrity are maintained.

The document recommends a harmonized approach that enables clinical trials to be initiated, adapted, and continued during PHEs, maintaining participant safety and data integrity and reliability.

Sponsors are encouraged to seek scientific advice from the European Medicines Agency's Emergency Task Force to accelerate processes, particularly with respect to authorizations and modifications.

 Main elements of the guidance

• Initiating new clinical trials: During a PHE, the national competent authorities should prioritize the assessment of clinical trials that are essential for understanding, mitigating, and addressing the PHE, temporarily placing less urgent clinical trials on hold.

• Changes to ongoing clinical trials: The guidance distinguishes three types of modifications during a PHE:
• Substantial modifications to include the investigation related to the PHE, such as adjusting the trial design, including new cohorts, adding or removing new trial arms, and expanding recruitment. These modifications will be subject to an accelerated evaluation process.
• Operational adaptations are needed so that trials can continue during a PHE, such as implementing remote informed consent, changes to visit schedules, temporary suspension of sites, direct shipment of investigation products to the participant’s address, and the implementation of remote source data verification. If they are substantial changes directly resulting from the PHE, they will also benefit from an accelerated evaluation process.
• Modifications unrelated to the PHE will be assessed according to standard timelines, unless they are combined with other PHE-related modifications. In exceptional cases requiring immediate action to protect participant safety, sponsors can implement changes without prior approval, communicating actions through the Urgent Safety Measure procedure available in the clinical trials information system.

• Adaptations to key aspects of the conduct of clinical trials: The guidance addresses different practical adaptations required during a PHE, of which we highlight the following:

• Regarding informed consent in PHEs, participants may find themselves in a more vulnerable situation; therefore, it is even more important that the consent process adheres to ethical and regulatory requirements, supporting the use of remote informed consent through secure, real-time audiovisual communications.
• Regarding safety monitoring, when the PHE affects in-person data collection, alternative collection methods such as phone calls, telemedicine visits, and electronic reporting may be used. In exceptional cases, data collection may even be restricted.
• Regarding investigation product management, the guidance acknowledges the direct shipment of products to participants’ places of residence, the redistribution of products across active sites, and the transfer of participants to sites unaffected by the PHE.
• The use of risk-based, remote, and centralized monitoring is still permitted, with source data verification focused on critical primary efficacy data and important safety data.

• Transfer of participants between sites: The guidance offers detailed information for situations where participants need to be transferred between investigation sites. Sponsors should verify that the receiving clinical sites have sufficient capacity and can assume medical responsibility for the transferred participants’ continued treatment. Transfer should only occur if epidemiological risks can be appropriately managed and if the move does not negatively impact public health. Renewed informed consent is required for continued participation.

• Methodological aspects: The guidance recognizes that a PHE can significantly impact recruitment, data collection, and analysis of clinical trials. Therefore, sponsors should assess how gaps in data collection, data loss, and protocol modifications could impact the statistical analyses.
•  Communication and transparency: Availability of trial results is especially important during a PHE to avoid duplication and to keep the general public informed of the collaborative efforts made by the academia, industry and regulators.

Next steps

The draft guidance document will be open for public consultation until April 30, 2026. Comments can be submitted using the official template and sending it to acteu@ema.europa.eu.

This document will be kept up to date in line with future EU legislation or guidance related to PHE and will be revised once the Clinical Trials Regulation amendments under the European Biotech Act are adopted. For more information on the European Biotech Act, click this link.