Patient-Reported Data In COVID-Impacted Trials: US FDA Cautions Against Missing Data, Potential Bias
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.
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US FDA's Peter Marks says the field is robust, but hedges on approval predictions for the coming years because of pandemic’s effect.
Steve Cutler, head of the CRO that conducted Pfizer’s study, tells the Pink Sheet that starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.
More patient-centric trial designs also may be coming due to pandemic-related advances, Marks says.