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On April 30th, the U.S. Food and Drug Administration (FDA) hosted a webinar about conducting clinical trials during the COVID-19 outbreak. Jacqueline Corrigan-Curay and John Concato, both from the Office of Medical Policy, reviewed the crucial parts from the recently updated FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency for sponsors, investigators and institutional review boards (IRBs). This article summarizes the key messages.
This guidance is built around three priorities:
It is important to note that this is general guidance. Particular situations with regard to the study population, investigational product, and trial phase or endpoint may require consultation with the appropriate FDA review division.
The first question that needs to be addressed is: should sponsors stop their trial?
The responsible party for the trial will also need to evaluate alternative procedures to ensure effective data collection and monitoring (e.g., videoconferencing, sending samples to local laboratories, remote access to the patient's file).
Other important recommendations from the FDA are:
As a final note, the agency is expecting many protocol deviations due to this international public health emergency, but it will be flexible where appropriate.
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