After First COVID-19 Vaccine Approval, How Will Other Trials Maintain Placebo Control?
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.
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India has rolled out draft guidelines for development of vaccines with special focus on COVID-19 vaccines, drawing from those of other regulatory bodies and the WHO. Experts suggest the primary efficacy endpoint of minimum 50% is acceptable given that vaccines against respiratory diseases are difficult to develop though not necessarily enough to snuff out a pandemic.
Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.
Investigators should plan to find the vital status of discontinued patients, guidances states. Participants need frequent reminders to complete PRO instruments, agency recommends.