Pandemic Perspectives: US FDA, NIH Tried To Be Flexible To Keep Rare Disease Trials Going

Both federal agencies extended grants to help investigators adapt to the changes mandated by the COVID-19 pandemic.

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NCATS Director Chris Austin said rare disease clinical trials will require rebuilding after the pandemic. • Source: Shutterstock

Rare disease clinical trials in the start-up phase seemed to suffer the most from the coronavirus outbreak, even as the US Food and Drug Administration and other funders tried to help investigators navigate the pandemic with minimal upheaval.

The FDA Office of Orphan Products Development said 5 March during the agency’s Rare Disease Day conference that 79% of clinical trials and natural history studies supported by

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