The Food and Drug Administration (FDA) issued guidance on conducting clinical trials during the COVID-19 outbreak (press release). The guidance is intended to provide general considerations to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize risk to trial integrity during the COVID-19 pandemic.
The FDA notes that the COVID-19 pandemic may impact the conduct of clinical trials for medical products and acknowledges that protocol modifications may be necessary or unavoidable due to quarantines, site closures, and travel limitations, among other challenges.
The FDA provides the following considerations to mitigate the effect of the outbreak on clinical trial conduct:
- Sponsors should prioritize the safety of trial participants and consider the circumstances of the outbreak when determining whether or not to continue the trial as originally designed.
- Sponsors should consider alternative methods for safety assessments, including phone contact, virtual visits, or alternative location for assessments.
- FDA details that COVID-19 screening that is required by a health care system in which a clinical trial is being conducted does not need to be reported as an amendment to the protocol.
- FDA encourages sponsors to engage with Institutional Review Boards (IRBs) and Independent Ethics Committee (IECs) as soon as possible when a change in protocol is anticipated due to COVID-19.
Additional considerations can be found on pages 5 through 8.