March 2020: FDA Offers More Advice on Mid-trial Changes for Pandemic-impacted Studies

On March 27th the FDA released a Q&A document in an appendix (page 10) to the March 18th “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” that discusses general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity during the COVID-19 pandemic. The appendix responds to questions the agency has received.

A protocol amendment is not needed to pause enrollment in a trial to decrease potential exposure to COVID-19, because such a pause would not be expected to significantly affect subject safety, the trial’s scope or its scientific quality, the FDA explains in the Q&A appendix.  Sponsors may consolidate several protocol modifications into a single protocol amendment because the agency “recognizes that during the rapidly evolving circumstances of a pandemic, a sequence of changes may be needed to address those circumstances.”

Such consolidation should be done expeditiously, the FDA said. In addition, clinical investigators still must document as protocol deviations any modifications to protocol-specified procedures that occur prior to institutional review board approval and FDA submission of the amendment implementing the changes.

Sponsors can document protocol deviations using their standard processes or, given the larger expected number of deviations, through alternative documentation approaches, the FDA said.  “For example, if visits are to be conducted by telephone/video contact rather than at the investigational site as specified in the protocol, documentation that provides a listing of all study visits (e.g., listing study reference number, patient ID, date of visit) that are deviations from the protocol due to the current COVID-19 situation generally would be acceptable,” the document states.

The document also includes advice for sponsors on initiating virtual clinical trial visits and what to do when on-site monitoring is delayed.

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