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Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says

 
• By Sue Sutter

Quarantines, travel restrictions and supply chain interruptions are likely to cause 'unavoidable protocol deviations' in ongoing clinical trials, FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by the coronavirus.

A walking path in a forrest splits and leads two different directions
Sponsors may need to find alternative ways of collecting clinical trial efficacy and safety data due to the impacts of COVID-19. • Source: Shutterstock

The US Food and Drug Administration is urging sponsors, clinical research organizations and investigators to consider alternative means for conducting safety assessments and collecting efficacy data to mitigate the impacts of the COVID-19 pandemic on ongoing clinical trials.

The recommendations could help drive data collection through digital means and spur greater adoption of remote clinical trial monitoring during the pandemic and even after it concludes. Some companies have...

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