Endpoints used in future registrational trials for preterm birth prevention drugs are likely to look quite different than those in the studies that led to the accelerated approval, and subsequent withdrawal, of Covis Pharma’s Makena (hydroxyprogesterone caproate).
Preterm Birth Prevention Studies Need To Look Beyond Makena Endpoints, Experts Say
Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’
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Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’
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