Curb Your Enthusiasm For Continued Use Of Pandemic Clinical Trial Flexibilities, US FDA Says

Even though many approaches were successful, the agency may need a couple years to determine if the data generated were actionable.

Hold your horses
The FDA is asking firms to hold their horses on permanently adopting all COVID-19 pandemic flexibilities, saying more research of their effectiveness is necessary. • Source: Shutterstock

Clinical trial and other flexibilities afforded sponsors during the COVID-19 pandemic may prove to be transformative to the research system eventually, but the US Food and Drug Administration is not ready to declare that today.

The pandemic functioned as a large-scale proof-of-concept effort for many clinical research innovations that sponsors and FDA officials had been advocating for implementation. Decentralized trials, remote monitoring and real-world evidence...

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