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Journal of Biopharmaceutical Statistics Volume 33, 2023 - Issue 6: Special Issue on Statistics in Pediatric Drug Development
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Research Article

Design of paediatric trials with benefit-risk endpoints using a composite score of adverse events of interest (AEI) and win-statistics

Yodit Seifua GBDS, Bristol-Myers Squibb, Berkeley Heights, New Jersey, USACorrespondence[email protected]
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,
Shahrul Mt-Isab BARDS, MSD, Zurich, SwitzerlandORCID Iconhttps://orcid.org/0000-0002-7163-8402View further author information
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Kyle Dukec Department of Statistics, North Caroline State University, Raleigh, North CarolinaView further author information
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Margaret Gamalo-Siebersd Global Biometrics and Data Management, Pfizer Inc, Collegeville, Pennsylvania, USAORCID Iconhttps://orcid.org/0000-0003-2428-3298View further author information
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William Wange BARDS, Merck & Co. Inc, Kenilworth, New Jersey, USAView further author information
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Gaohong Dongf BeiGene, Ridgefield Park, New Jersey, USAORCID Iconhttps://orcid.org/0000-0002-9848-1329View further author information
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John Kolassag Department of Statistics, Rutgers, the State University of NJ, Piscataway, New Jersey, USAView further author information
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Pages 696-707 | Received 12 Mar 2022, Accepted 23 Nov 2022, Published online: 22 Dec 2022

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Margaret Gamalo, Jingjing Ye, YounJeong Choi & Rima Izem. (2023) Pediatric needs should be considered early in the clinical development lifecycle. Journal of Biopharmaceutical Statistics 33:6, pages 677-680.
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Lu Mao & Tuo Wang. (2023) Dissecting the restricted mean time in favor of treatment. Journal of Biopharmaceutical Statistics 0:0, pages 1-16.
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