Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities

Affiliations

• ¹ Office of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD. Electronic address: an.massaro@fda.hhs.gov.
• ² Duke-Margolis Center for Health Policy, Washington, DC.
• ³ Department of Pediatrics, The University of North Carolina at Chapel Hill, Chapel Hill, NC.
• ⁴ Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD.
• ⁵ Duke-Margolis Center for Health Policy, Washington, DC; Departments of Pediatrics and Population Health Sciences, Duke University School of Medicine, Durham, NC.
• ⁶ Hope for HIE, West Bloomfield, MI.
• ⁷ Office of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD.