The FDA has broken down several of its guidelines, creating a step-by-step resource for trials being conducted in language directly to study sponsors.
In late March, the FDA issued Guidance for Industry, Investigators, and Institutional Review Boards via their Guidance Document, entitled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency.”
Created to offer direction and assistance in ensuring the safety of COVID-19 trial participants, while maintaining compliance, the guidance offered support around trials scheduled or trials occurring during the global health crisis.
Focused on maintaining safety procedures, the FDA has broken down several of its guidelines in the document, creating a step-by-step resource for trials being conducted in language directly to sponsors.
Here are two points of consideration for study sponsors, institutional review boards and investigators:
- If sponsors are deviating or modifying protocol-specific procedures due to COVID-19 safety factors, the FDA has asked sponsors to document the specific changes and the reason for each change. The FDA further explained, “For a study-wide change in protocol conduct, protocol amendments that are necessary to prevent Contains Nonbinding Recommendations 12 imminent hazards to trial participants can generally be immediately implemented with subsequent submission and formal approval by the IRB/IEC and notification to FDA through filing a protocol amendment to the investigational new drug (IND) or deviation from the investigational device exemption (IDE).”
- If urgent situations occur, sponsors should contact the lead reviewer of the study. If FDA feedback is needed on a proposed future study (or modifications are being requested on a current study,) the FDA is asking for sponsors to complete a Pre-Submission document. (Information around the document needed can be found here and here.)
- If a trial has a specific COVID-19 impact, (due to the public health emergency,) the FDA declared that sponsors should describe three things:
- Contingency measures implemented when the study is disrupted due to the pandemic
- A full list of all participants affected by the disruption with a unique subject number identifier (as well as by investigational site) and also a description of how the individual’s actions or participation were altered
- An analysis that cites specific information that addresses the impact of COVID-19 on the study. The FDA expands on the direction, saying, “Robust efforts by sponsors, investigators, and IRBs/IECs to maintain the safety of trial participants and study data integrity are expected, and such efforts should be documented.”
The FDA has the document in its entirety available online. Included in the document is a Q&A, addressing questions from sponsors and those involved in the studies that address remote capabilities and acceptable alternatives due to the pandemic.
The FDA is taking comments on their guidance. Insights may be submitted online here while questions on clinical trial conduct during the COVID-19 pandemic can be emailed to: Clinicaltrialconduct-COVID19@fda.hhs.gov.