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Patient-Reported Data In COVID-Impacted Trials: US FDA Cautions Against Missing Data, Potential Bias

 
• By Sue Sutter

Considerations for switching from in-person to remote collection of patient- and observer-reported outcomes addressed in latest update to Q&A guidance, which also discusses Part 11 compliance requirements in the context of the pandemic and electronic collection of informed consent through MyStudies app.

Pc monitor view over girl shoulder, old doctor wear uniform headset give consultation to client via internet about epidemic outbreak of corona virus ncov, distant communication and protection concept
US FDA outlines issues to consider in switching to remote collection of patient-reported outcomes. • Source: Shutterstock

Clinical trial sponsors should consider the potential for missing data and bias when deciding whether to switch from in-person to remote collection of observer-reported and patient-reported outcome assessments during the COVID-19 pandemic, the US Food and Drug Administration says.

In the latest update to its question-and-answer guidance on managing the novel coronavirus’ impact on clinical trials, the agency...

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