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Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities.
Lim, Jessica; Walley, Rosalind; Yuan, Jiacheng; Liu, Jeen; Dabral, Abhishek; Best, Nicky; Grieve, Andrew; Hampson, Lisa; Wolfram, Josephine; Woodward, Phil; Yong, Florence; Zhang, Xiang; Bowen, Ed.
Afiliación
  • Lim J; 1 Clinical Statistics, GlaxoSmithKline, Collegeville, PA, USA.
  • Walley R; 2 Centre for Excellence in Statistical Innovation, UCB, UK.
  • Yuan J; 3 Statistical Science and Programming, Allergan, Irvine, CA, USA.
  • Liu J; 3 Statistical Science and Programming, Allergan, Irvine, CA, USA.
  • Dabral A; 3 Statistical Science and Programming, Allergan, Irvine, CA, USA.
  • Best N; 4 Advanced Biostatistics and Data Analytics Centre of Excellence, GlaxoSmithKline, Uxbridge, Middlesex, UK.
  • Grieve A; 2 Centre for Excellence in Statistical Innovation, UCB, UK.
  • Hampson L; 5 Statistical Methodology & Consulting, Novartis Pharma AG, Basel.
  • Wolfram J; 6 Data Science Biostatistics, Astellas, Leiden, the Netherlands.
  • Woodward P; 7 Independent Consultant, Newmarket, UK.
  • Yong F; 8 Biostatistics, Worldwide Research & Development, Pfizer, Cambridge, MA, USA.
  • Zhang X; 9 Global Statistical Science, Eli Lilly and Company, Indianapolis, IN, USA.
  • Bowen E; 10 R&D Data Centre of Excellence, GlaxoSmithKline, Collegeville, PA, USA.
Ther Innov Regul Sci ; 52(5): 546-559, 2018 09.
Article en En | MEDLINE | ID: mdl-29909645
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Grupos Control / Ensayos Clínicos como Asunto Tipo de estudio: Clinical_trials / Prognostic_studies Idioma: En Revista: Ther Innov Regul Sci Año: 2018 Tipo del documento: Article
Texto completo
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PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Grupos Control / Ensayos Clínicos como Asunto Tipo de estudio: Clinical_trials / Prognostic_studies Idioma: En Revista: Ther Innov Regul Sci Año: 2018 Tipo del documento: Article