Preventing Missing Data Among Concerns In US FDA’s Guidance On COVID-19 Symptom Assessment
Investigators should plan to find the vital status of discontinued patients, guidances states. Participants need frequent reminders to complete PRO instruments, agency recommends.
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US FDA has the unenviable task of picking the most important adverse events to track once coronavirus vaccinations begin; CDC's list will need to be winnowed to 10-20 to make the surveillance feasible, and which AEs make the cut may be informed by the vaccine trials, as well as clinical experience with COVID infections.
When the US FDA approved Olumiant (baricitinib) for RA, it insisted on a lower dose because of fears of blood clots. Now that an NIH trial has shown that the product plus Gilead’s Veklury (remdesivir) provided a statistically significant reduction in time to recovery versus remdesivir alone for hospitalized COVID patients, Olumaint may get an emergency use authorization from FDA to treat a condition that itself causes blood clots. That doesn't mean the black box is going away; it's just a reminder that there is as much magic and mystery to medicine sometimes as there is science.
US FDA officials fear comparator arms would be unwieldy for ongoing trials as they consider alternative methods to measure efficacy if placebo controls can't be maintained for the studies of other candidate vaccines once a product is on the market.