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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COVID-19 Therapeutic Trials: Investigators Should Join Forces Rather Than Conduct Single Site Studies
‘Treacherous combination’ of small clinical trials, lagging enrollment, unreported results and uncompleted trials is hindering COVID-19 research, former FDA Commissioner Califf says. Yale professor calls for a ‘Manhattan Project’ around knowledge and a change in the academic star system.
US FDA Acting Commissioner Woodcock says there is ‘a long list’ of lessons learned in the OWS therapeutics group, noting trial bureaucracy and the lack of resources and support for community centers.
Since the WHO’s pandemic declaration, the agency has granted 10 EUAs for therapeutics and three for vaccines, all of which were reviewed in less than 90 days; EUA requests from government entities boast two of the three fastest review times but were revoked or limited in the face of emerging evidence.