Early ‘Scattershot’ Approach To COVID-19 Therapeutic Research Generated Little Actionable Data
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.
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High-profile programs, such as convalescent plasma, also created public confusion about role of preapproval access and highlighted the importance of prospectively planning for reliable data collection, experts said at the DIA global annual meeting.
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?
CRS poses series of questions about how a new federal agency tasked with speeding translational research for treating high-impact diseases would work, including potential downsides and whether it would duplicate government programs already in place.