FDA guidance on conducting trials during emergencies shifts away from COVID-19
The US Food and Drug Administration (FDA) issued revised final guidance to assist sponsors, investigators, and institutional review boards conducting clinical trials during disasters and public heath emergencies (PHEs), focusing on patient safety, maintaining compliance with good clinical practice, and minimizing risk to trial integrity.The guidance, announced in the Federal Register on 21 September 2023, has been revised to shift the focus from the COVID-19 pandemic to other public health emergencies and natural disasters. It also removes certain redundant questions and changes adverse event reporting references related to COVID-19 treatments to treating or preventing conditions related to a disaster or a PHE.
“FDA recognizes that disasters and PHEs can cause major disruptions to the conduct of clinical trials of medical products. For example, disasters or PHEs can lead to population quarantines, trial site closures, travel limitations, interruptions to the supply chain for the investigational product (IP), or other challenges related to the type of disaster or PHE (e.g., site personnel or trial participants infected during an outbreak),” the agency wrote in the guidance.
Such challenges “can create difficulties in complying with protocol-specified procedures, including administering or using the IP or adhering to protocol-specified visits and laboratory or diagnostic testing,” according to the guidance.
Emergencies can include hurricanes, earthquakes, military conflicts, infectious disease outbreaks, or bioterrorist attacks.
The guidance supersedes an earlier version issued in March 2020 during the COVID-19 pandemic and an update issued in August 2021 but maintains many of the earlier recommendations (RELATED: FDA Unveils Guidance or Trials Impacted by COVID-19, Regulatory Focus 18 March 2020).
The guidance addresses considerations for either continuing or terminating trials, managing changes to policies and procedures during study disruptions, contingency measures to manage the study during a disaster or a PHE, and addressing how to treat a disaster or a PHE in a clinical study report.
The appendix, which is written in a question-and-answer format, addresses potential emergency scenarios in more details, including:
- Suspending, continuing, and initiating trials
- Managing protocol deviations and amendments
- Submitting changes to the investigational new drug (IND) and investigational device exemption (IDE) protocol
- Capturing data on protocol and process deviations
- Conducting remote or virtual clinic visits
- Conducting remote clinical trial assessments
The guidance takes effect immediately.
Guidance; Notice
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