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USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions

Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and the Oncology Center of Excellence, published final guidance, Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies”.

Disasters and public health emergencies (PHEs) have the potential to cause major disruptions in the conduct of clinical trials for medical products, Events can include (but are not limited to) hurricanes, earthquakes, military conflicts, infectious disease outbreaks, or bioterrorist attacks.

The FDA is issuing this guidance to help sponsors, institutional review boards (IRBs), and clinical investigators ensure the safety of trial participants, maintain compliance with good clinical practice (GCP), and minimize risks to trial integrity during disasters and PHEs that can seriously disrupt clinical trial operations and conduct.

In this guidance, FDA outlines the general considerations to assist sponsors in ensuring the safety of trial participants, maintaining compliance with GCP, and minimizing risks to trial integrity.

The determination of whether to continue a trial should be based first and foremost on ensuring that participants will continue to be able to participate safely.

The determination should also consider whether the key objectives of the trial can still be met, with appropriate trial modifications implemented.

The appendix to this guidance further explains these general considerations in a question-and-answer format.


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