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Estimation Methods for Estimands Using the Treatment Policy Strategy; a Simulation Study Based on the PIONEER 1 Trial.

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第一作者： James,Bell

第一单位： Biostatistics and Clinical Data Sciences, Elderbrook Solutions GmbH, Buckinghamshire, UK.

作者： James,Bell ^[1] ; Thomas,Drury ^[2] ; Tobias,Mütze ^[3] ; Christian Bressen,Pipper ^[4] ; Lorenzo,Guizzaro ^[5] ; Marian,Mitroiu ^[6] ; Khadija Rerhou,Rantell ^[7] ; Marcel,Wolbers ^[8] ; David,Wright ^[9]

作者单位： Biostatistics and Clinical Data Sciences, Elderbrook Solutions GmbH, Buckinghamshire, UK. ^[1] Statistics & Data Science Innovation Hub, GlaxoSmithKline, London, UK. ^[2] Advanced Quantitative Sciences, Novartis Pharma AG, Basel, Switzerland. ^[3] Methods and Outreach, Biostatistics, Novo Nordisk A/S, Soeborg, Denmark & Dept. of Public Health, University of Southern Denmark, Odense, Denmark. ^[4] Human Medicines, European Medicines Agency, Domenico Scarlattilaan 6, Amsterdam, The Netherlands. ^[5] Biostatistics, Quantitative Sciences & Development Operations, Biogen International GmbH, Baar, Zug, Switzerland. ^[6] Medicines and Healthcare products Regulatory Agency, London, UK. ^[7] Statistical Methods, Collaboration, and Outreach, Data and Statistical Sciences, Pharma Development, Roche, Basel, Switzerland. ^[8] Statistical Innovation, Respiratory and Immunology Biometrics and Statistical Innovation, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK. ^[9]

关键词 estimand estimation intercurrent event multiple imputation reference‐based imputation retrieved dropout simulation study treatment policy