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

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Title: Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities.
Authors: Massaro AN; Office of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD. Electronic address: an.massaro@fda.hhs.gov., Boyer B; Duke-Margolis Center for Health Policy, Washington, DC., Gill M; Duke-Margolis Center for Health Policy, Washington, DC., Kim D; Duke-Margolis Center for Health Policy, Washington, DC., Laughon M; Department of Pediatrics, The University of North Carolina at Chapel Hill, Chapel Hill, NC., Walsh M; Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD., Lemmon ME; Duke-Margolis Center for Health Policy, Washington, DC; Departments of Pediatrics and Population Health Sciences, Duke University School of Medicine, Durham, NC., Pilon B; Hope for HIE, West Bloomfield, MI., Baer G; Office of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD.
Corporate Authors: Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants
Source: The Journal of pediatrics [J Pediatr] 2024 Jun; Vol. 269, pp. 113972. Date of Electronic Publication: 2024 Feb 22.
Publication Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
Journal Info: Publisher: Mosby Country of Publication: United States NLM ID: 0375410 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6833 (Electronic) Linking ISSN: 00223476 NLM ISO Abbreviation: J Pediatr Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Massaro+AN%22">Massaro AN</searchLink>; Office of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD. Electronic address: an.massaro@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Boyer+B%22">Boyer B</searchLink>; Duke-Margolis Center for Health Policy, Washington, DC.<br /><searchLink fieldCode="AU" term="%22Gill+M%22">Gill M</searchLink>; Duke-Margolis Center for Health Policy, Washington, DC.<br /><searchLink fieldCode="AU" term="%22Kim+D%22">Kim D</searchLink>; Duke-Margolis Center for Health Policy, Washington, DC.<br /><searchLink fieldCode="AU" term="%22Laughon+M%22">Laughon M</searchLink>; Department of Pediatrics, The University of North Carolina at Chapel Hill, Chapel Hill, NC.<br /><searchLink fieldCode="AU" term="%22Walsh+M%22">Walsh M</searchLink>; Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD.<br /><searchLink fieldCode="AU" term="%22Lemmon+ME%22">Lemmon ME</searchLink>; Duke-Margolis Center for Health Policy, Washington, DC; Departments of Pediatrics and Population Health Sciences, Duke University School of Medicine, Durham, NC.<br /><searchLink fieldCode="AU" term="%22Pilon+B%22">Pilon B</searchLink>; Hope for HIE, West Bloomfield, MI.<br /><searchLink fieldCode="AU" term="%22Baer+G%22">Baer G</searchLink>; Office of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD.
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