Better Late Than Never? US FDA’s Oddly Timed COVID Master Protocol Guidance
COVID has unequivocally shown the advantages of a ‘master protocol’ approach to providing definitive evidence about the benefits (or lack thereof) for repurposed therapies to treat a novel infection. Unfortunately, in the US, the proof has been in the failure of scores of separate studies to generate useful evidence. Can FDA change that before the next pandemic?
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Agency seeking comment on document intended to replace the just-issued guidance on COVID-19 treatment development as FDA stresses the value of master protocols for developing clinical knowledge.
US FDA and NIH leaders cite lack of early clinical trial coordination as a weakness in the pandemic response that led to use of compounds that were potentially harmful and, even today, still not proven to be effective.
COVID-19 has helped demonstrate the viability of platform trials with a shared control arm. That model is easier to extol than it is for sponsors to embrace, especially outside of crisis mode.