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Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials.
Collignon, Olivier; Gartner, Christian; Haidich, Anna-Bettina; James Hemmings, Robert; Hofner, Benjamin; Pétavy, Frank; Posch, Martin; Rantell, Khadija; Roes, Kit; Schiel, Anja.
Afiliación
  • Collignon O; Competence Centre in Methodology and Statistics, Luxembourg Institute of Health, Strassen, Luxembourg.
  • Gartner C; AGES - Österreichische Agentur für Gesundheit und Ernährungssicherheit/Austrian Agency for Health and Food Safety, Vienna, Austria.
  • Haidich AB; Department of Hygiene, Social-Preventive Medicine & Medical Statistics, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • James Hemmings R; Consilium Hemmings, Unit 96, The Maltings Business Center, The Maltings, Stanstead Abbotts, UK.
  • Hofner B; Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
  • Pétavy F; European Medicines Agency, Amsterdam, The Netherlands.
  • Posch M; Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
  • Rantell K; Medicines and Healthcare Products Regulatory Agency, London, UK.
  • Roes K; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
  • Schiel A; Legemiddelverket, Oslo, Norway.
Clin Pharmacol Ther ; 107(5): 1059-1067, 2020 05.
Article en En | MEDLINE | ID: mdl-32017052

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Proyectos de Investigación / Ensayos Clínicos como Asunto / Interpretación Estadística de Datos Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2020 Tipo del documento: Article País de afiliación: Luxemburgo

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Proyectos de Investigación / Ensayos Clínicos como Asunto / Interpretación Estadística de Datos Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2020 Tipo del documento: Article País de afiliación: Luxemburgo