Early phase clinical trials extension to guidelines for the content of statistical analysis plans.

Homer, Victoria; Yap, Christina; Bond, Simon; Holmes, Jane; Stocken, Deborah; Walker, Katrina; Robinson, Emily J; Wheeler, Graham; Brown, Sarah; Hinsley, Samantha; Schipper, Matthew; Weir, Christopher J; Rantell, Khadija; Prior, Thomas; Yu, Ly-Mee; Kirkpatrick, John; Bedding, Alun; Gamble, Carrol; Gaunt, Piers

Homer, Victoria; Yap, Christina; Bond, Simon; Holmes, Jane; Stocken, Deborah; Walker, Katrina; Robinson, Emily J; Wheeler, Graham; Brown, Sarah; Hinsley, Samantha; Schipper, Matthew; Weir, Christopher J; Rantell, Khadija; Prior, Thomas; Yu, Ly-Mee; Kirkpatrick, John; Bedding, Alun; Gamble, Carrol; Gaunt, Piers.

Afiliação

Homer V; Cancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Yap C; Clinical Trials and Statistics Unit, Institute for Cancer Research, London, UK.
Bond S; Cambridge Clinical Trials Unit, Cambridge, UK.
Holmes J; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Stocken D; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Walker K; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Robinson EJ; Royal Marsden Clinical Trials Unit, Royal Marsden NHS Foundation Trust, London, UK.
Wheeler G; Imperial Clinical Trials Unit, Imperial College London, London, UK.
Brown S; Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Hinsley S; Cancer Research UK Glasgow Clinical Trials Unit, University of Glasgow, Glasgow, UK.
Schipper M; Departments of Radiation Oncology and Biostatistics, University of Michigan, Ann Arbor, MI, USA.
Weir CJ; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.
Rantell K; Medicines and Healthcare products Regulatory Agency, London, UK.
Prior T; Early Development Oncology Statistics Department, Janssen Research and Development, Spring House, PA, USA.
Yu LM; Primary Care Clinical Trials Unit, University of Oxford, Oxford, UK.
Kirkpatrick J; Roche Products, Welwyn Garden City, UK.
Bedding A; Roche Products, Welwyn Garden City, UK.
Gamble C; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
Gaunt P; Cancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK p.gaunt@bham.ac.uk.

BMJ ; 376: e068177, 2022 02 07.

Article em En | MEDLINE | ID: mdl-35131744

Assuntos

Ensaios Clínicos como Assunto; Análise de Dados; Guias como Assunto

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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Ensaios Clínicos como Assunto / Guias como Assunto / Análise de Dados Tipo de estudo: Guideline Idioma: En Revista: BMJ Assunto da revista: MEDICINA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Reino Unido

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