Combining evidence from clinical trials in conditional or accelerated approval.

Deforth, Manja; Micheloud, Charlotte; Roes, Kit C; Held, Leonhard

Deforth, Manja; Micheloud, Charlotte; Roes, Kit C; Held, Leonhard.

Afiliação

Deforth M; Department of Biostatistics at the Epidemiology, Biostatistics and Prevention Institute (EBPI) and Center for Reproducible Science (CRS), University of Zurich, Zurich, Switzerland.
Micheloud C; Department of Biostatistics at the Epidemiology, Biostatistics and Prevention Institute (EBPI) and Center for Reproducible Science (CRS), University of Zurich, Zurich, Switzerland.
Roes KC; Department of Health Evidence, Section Biostatistics, Radboud University Medical Center, Radboud University, Nijmegen, The Netherlands.
Held L; Department of Biostatistics at the Epidemiology, Biostatistics and Prevention Institute (EBPI) and Center for Reproducible Science (CRS), University of Zurich, Zurich, Switzerland.

Pharm Stat ; 22(4): 707-720, 2023.

Article em En | MEDLINE | ID: mdl-37114714

Assuntos

Aprovação de Drogas; Humanos; Tamanho da Amostra; Estados Unidos; Ensaios Clínicos como Assunto

Palavras-chave

accelerated approval; conditional approval; harmonic mean chi-squared test; interim power; sample size calculation; two-trials rule

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aprovação de Drogas Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Pharm Stat Assunto da revista: FARMACOLOGIA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Suíça País de publicação: Reino Unido

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