Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says
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.
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What on earth would make a biotech company change the primary endpoint half way through a Phase III program and not discuss it with the FDA? There are at least two scenarios, neither of them good.
In journal article, leaders from academia, industry, NCI and FDA propose building upon pandemic-necessitated flexibilities in clinical research, including making it easier for trial participants to access investigational drugs in their own communities and reduced reporting of uninformative adverse events.
US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.