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

Seifu, Yodit; Mt-Isa, Shahrul; Duke, Kyle; Gamalo-Siebers, Margaret; Wang, William; Dong, Gaohong; Kolassa, John

Seifu, Yodit; Mt-Isa, Shahrul; Duke, Kyle; Gamalo-Siebers, Margaret; Wang, William; Dong, Gaohong; Kolassa, John.

Afiliación

Seifu Y; GBDS, Bristol-Myers Squibb, Berkeley Heights, New Jersey, USA.
Mt-Isa S; BARDS, MSD, Zurich, Switzerland.
Duke K; Department of Statistics, North Caroline State University, Raleigh, North Carolina.
Gamalo-Siebers M; Global Biometrics and Data Management, Pfizer Inc, Collegeville, Pennsylvania, USA.
Wang W; BARDS, Merck & Co. Inc, Kenilworth, New Jersey, USA.
Dong G; BeiGene, Ridgefield Park, New Jersey, USA.
Kolassa J; Department of Statistics, Rutgers, the State University of NJ, Piscataway, New Jersey, USA.

J Biopharm Stat ; 33(6): 696-707, 2023 11 02.

Article en En | MEDLINE | ID: mdl-36545791

Asunto(s)

Medición de Riesgo; Adulto; Humanos; Niño; Simulación por Computador; Tamaño de la Muestra; Determinación de Punto Final/métodos

Palabras clave

AEI composite score; Benefit-risk assessment; win-statistics

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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Medición de Riesgo Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Adult / Child / Humans Idioma: En Revista: J Biopharm Stat Asunto de la revista: FARMACOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

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