Woodcock Warns Research Apparatus Could Be Overwhelmed If Coronavirus Trials Don’t Use Master Protocols
CDER Director Janet Woodcock says researchers need to embrace pragmatic trial designs and compare multiple treatments at the same time rather than employ separate development programs.
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Acting FDA commissioner says there are a lot of strong forces in the research and pharma industries that could curb efforts to make pandemic-related clinical trial reforms permanent.
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?
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.