Clinical trial site remote monitoring may suffice: Updated FDA guidance
Remote monitoring to oversee clinical trials has been one of the flexibilities the US Food and Drug Agency (FDA) has, in some cases, permitted during the COVID-19 pandemic. Now that some pandemic-related restrictions are lifted, though, does remotely obtained site information “count,” or do these sites need to be re-monitored in person?
To respond to this knowledge gap, a new question and accompanying answer (Q and A) have been appended to the final guidance document about the conduct of clinical trials during the public health emergency of the COVID-19 pandemic.
As with other regulatory processes, FDA advises that the sponsor should use an ongoing assessment of risk to drive the answer to the question of whether a new, onsite monitoring visit is required at a given clinical trial site.
“The sponsor may determine that on-site follow-up of remote monitoring activities is appropriate based on a risk assessment (e.g., sites with certain data anomalies or a higher frequency of errors, important protocol violations, or dropouts relative to other sites),” wrote FDA in its response to the newly added question.
However, the new addition to the guidance does not specify that a clinical trial site must undergo on-site monitoring if concerns are not triggered by the sponsor’s risk assessment.
Citing inquiries from sponsors, FDA pointed out that a variety of challenges besides travel and occupancy restrictions can impact the conduct of clinical trials during the public health emergency. These may include isolation practices, complete closure of certain sites, supply chain disruptions for investigational products, and the potential for site personnel and trial participants to be isolated or ill from exposure to or infection with SARS-CoV-2. “These challenges may lead to difficulties in conducting the clinical trials,” noted FDA in announcing the new Q and A.
Protocol modification and even “unavoidable protocol deviations” might occur as a result of these external variables, acknowledged FDA. The guidance gives general considerations for how to balance the risk to participants and data quality in the face of such unknowns.
The guidance on the conduct of clinical trials during the pandemic was originally issued in March 2020, and has undergone several revisions since the document was first published as an immediately effective final guidance. (RELATED: FDA unveils guidance for trials impacted by COVID-19, Regulatory Focus 18 March 2020)
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