Reducing Patient Burden in Clinical Trials Through the Use of Historical Controls: Appropriate Selection of Historical Data to Minimize Risk of Bias.

Lim, Jessica; Wang, Li; Best, Nicky; Liu, Jeen; Yuan, Jiacheng; Yong, Florence; Zhang, Lanju; Walley, Rosalind; Gosselin, Alice; Roebling, Robert; Viele, Kert

Lim, Jessica; Wang, Li; Best, Nicky; Liu, Jeen; Yuan, Jiacheng; Yong, Florence; Zhang, Lanju; Walley, Rosalind; Gosselin, Alice; Roebling, Robert; Viele, Kert.

Afiliação

Lim J; Clinical Statistics, GSK, 1250 S. Collegeville Road, Collegeville, PA, 19426-0989, USA. jessica.w.lim@gsk.com.
Wang L; Data and Statistical Sciences, Abbvie, North Chicago, IL, USA.
Best N; Advanced Biostatistics and Data Analytics, GSK, Uxbridge, Middlesex, UK.
Liu J; Statistical Science and Programming, Allergan, Irvine, CA, USA.
Yuan J; Statistical Science and Programming, Allergan, Irvine, CA, USA.
Yong F; Biostatistics, Worldwide Research & Development, Pfizer, Cambridge, MA, USA.
Zhang L; Data and Statistical Sciences, Abbvie, North Chicago, IL, USA.
Walley R; Centre for Excellence in Statistical Innovation, UCB, Slough, UK.
Gosselin A; Biostatistics and Programming, Sanofi, Paris, France.
Roebling R; Global Clinical Development and Medical Affairs, UCB, Monheim, Germany.
Viele K; Berry Consultants, Austin, TX, USA.

Ther Innov Regul Sci ; 54(4): 850-860, 2020 07.

Article em En | MEDLINE | ID: mdl-32557308

Assuntos

Doenças Raras; Viés; Criança; Humanos

Palavras-chave

Clinical trials; Historical controls; Selection bias; TransCelerate

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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Doenças Raras Tipo de estudo: Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Child / Humans Idioma: En Revista: Ther Innov Regul Sci Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos

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