Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

Regulatory NewsRegulatory News | 22 September 2020 |  By 

Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US Food and Drug Administration (FDA). 
The updated information came on 21 September 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency. The guidance, originally issued in March 2020, has been expanded and updated throughout the pandemic. (RELATED: E-signatured clarified in FDA’s COVID-19 clinical trial guidance, Regulatory Focus 04 June 2020)
The guidance now clarifies that even in the context of increased volume of IND safety reports during the pandemic, the review of safety reports is still a critical part of the investigator’s role in the safe conduct of clinical trials. According to the updated guidance, although “trial participants with COVID-19 may experience a number of serious and unexpected adverse clinical events,” investigators must review all investigational new drug (IND) safety reports.
The agency notes that under 21 CFR 312.60, “[I]nvestigators are responsible for protecting the safety of trial participants in clinical investigation." In all cases, IND safety reports have to go to the FDA and to all investigators if the study sponsor determines that an adverse event is serious, unexpected, and "[T]here is a reasonable possibility that the drug caused the serious adverse event,” so that a causal relationship may exist  between the study drug and the adverse events.
In deciding which adverse events should be reported to an IRB, investigators should consider whether the event in question constitutes an unanticipated problem that involves risk to human subjects or others, according to 21 CFR 312.66.The guidance also clarifies that if serious adverse events meet criteria for safety reporting for an IND-exempt bioavailability / bioequivalence study they would generally also meet the threshold of “unanticipated problems involving risk to human subjects or others” and would need to be reported to the IRB.



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