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Pre-existing clinical trials should be adapted during public health emergencies, draft guidance from the Accelerating Clinical Trials in the EU (ACT EU) initiative has said.
The guidance, published on 4 March 2026, says: “[During a public health emergency], every effort should be made to adapt ongoing clinical trials or those already authorised before the start of the public health emergency, to obtain relevant clinical trial results as fast as possible.”
Adaptations could include changing trial endpoints, including a new cohort of patients, adding new trial arms with new investigational agents, and adapting randomisation to reflect the needs of the public health emergency, the draft guidance said.
“Proposed modifications should be related to the investigation of the prevention or treatment of medical conditions related to the public health emergency,” it added.
The ACT EU initiative is made up of the European Medicines Agency, European Commission and Heads of Medicines Agencies and aims to transform the European clinical trial system.
The draft guidance also states that trial sponsors should apply only essential measures that will not jeopardise patient safety or data integrity when modifying trials during emergencies.
Measures could include adjustments to the informed consent process, such as allowing remote consent, changing the trial recruitment process and transfer of trial participants to sites away from risk zones.
The guidance will not apply in the UK, but commenting on the draft guidance, Amira Guirguis, chief scientist at the Royal Pharmaceutical Society, said: “Clear guidance on how clinical trials can be adapted during public health emergencies can help ensure vital research continues while protecting participants and maintaining robust scientific standards.
“Building on the UK’s strong clinical research infrastructure, having frameworks in place to support the rapid adaptation or prioritisation of trials could help generate reliable, high-quality evidence more quickly to inform patient care and public health decisions.”
Other proposals in the draft guidance include prioritising initiation of trials that serve the public health emergency and pausing less urgent trials, where necessary.
The draft guidance is open for public consultation until 30 April 2026.
