Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities - 14/05/24

Doi : 10.1016/j.jpeds.2024.113972

An N. Massaro, MD ^1,^⁎ , Beth Boyer, MPH ², Mira Gill, MS ², Dure Kim, PharmD ², Matthew Laughon, MD, MPH ³, Michele Walsh, MD ⁴, Monica E. Lemmon, MD ^2,⁵, Betsy Pilon, BA ⁶, Gerri Baer, MD ¹
on behalf of the
Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants^∗
Consortium Author List (alphabetical):Keith Barrington, Sainte Justine University Health CenterDiana W. Bianchi, Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentJaNeen Cross, Howard University School of Social WorkAshley Darcy-Mahoney, George Washington University School of Nursing & PediatrixDeb Discenza, PreemieWorldDaniel Fuentes, Chiesi USA, Inc.Dionna Green, U.S. Food and Drug AdministrationGerrit Hamre, Duke-Margolis Center for Health PolicyKevin Hill, Duke University Medical CenterErik Jensen, University of Pennsylvania Perelman School of Medicine and Children's Hospital of PhiladelphiaNaomi Knoble, U.S. Food and Drug AdministrationNancy Allen Lapointe, Duke-Margolis Center for Health PolicyMelissa Lestini, U.S. Food and Drug AdministrationHilary Marston, U.S. Food and Drug Administration Susan McCune, PPD Clinical Research Business, Thermo Fisher ScientificMartin Offringa, The Hospital for Sick Children, University of Toronto, CanadaClaudia Pedroza, The University of Texas Health Science Center at HoustonBarbara Schmidt, McMaster University & University of PennsylvaniaSuna Seo, U.S. Food and Drug AdministrationKanwaljit Singh, Critical Path InstituteJanet S. Soul, Boston Children’s Hospital, Harvard Medical SchoolGenny Taylor, The University of North Carolina at Chapel HillKristi Watterberg, University of New MexicoKanecia Zimmerman, Duke University School of Medicine
Keith Barrington, Diana W. Bianchi, JaNeen Cross, Ashley Darcy-Mahoney, Deb Discenza, Daniel Fuentes, Dionna Green, Gerrit Hamre, Kevin Hill, Erik Jensen, Naomi Knoble, Nancy Allen Lapointe, Melissa Lestini, Hilary Marston, Susan McCune, Martin Offringa, Claudia Pedroza, Barbara Schmidt, Suna Seo, Kanwaljit Singh, Janet S. Soul, Genny Taylor, Kristi Watterberg, Kanecia Zimmerman

¹ Office of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD
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 Departments of Pediatrics and Population Health Sciences, Duke University School of Medicine, Durham, NC
⁶ Hope for HIE, West Bloomfield, MI

^∗Reprint requests: An N. Massaro, MD, Neonatology, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993.NeonatologyUS Food and Drug Administration10903 New Hampshire AvenueSilver Spring, MD20993

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Plan

Challenges in Measuring Efficacy

Past and Current Approaches

Progress and Promising New Approaches

Looking Forward

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Article 113972- juin 2024 Retour au numéro

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Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities - 14/05/24

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