US FDA Offers More Advice On Mid-Trial Changes For Pandemic-Impacted Studies
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.
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Routine inclusion of approaches such as local assessments and remote monitoring could reduce patient burden and avoid protocol deviations, but industry needs to see a return on investment, in the form of easier recruitment, better diversity and/or faster studies, experts said.
In journal article, leaders from academia, industry, NCI and FDA propose building upon pandemic-necessitated flexibilities in clinical research, including making it easier for trial participants to access investigational drugs in their own communities and reduced reporting of uninformative adverse events.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.