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Frequentist rules for regulatory approval of subgroups in phase III trials: A fresh look at an old problem.

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Title: Frequentist rules for regulatory approval of subgroups in phase III trials: A fresh look at an old problem.
Authors: Edgar K; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK., Jackson D; Statistical Innovation, Oncology R&D, AstraZeneca, AstraZeneca, Cambridge, UK., Rhodes K; Statistical Innovation, Oncology R&D, AstraZeneca, AstraZeneca, Cambridge, UK., Duffy T; Statistical Innovation, BioPharmaceutical R&D, AstraZeneca, Gothenburg, Sweden., Burman CF; Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK., Sharples LD; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Source: Statistical methods in medical research [Stat Methods Med Res] 2021 Jul; Vol. 30 (7), pp. 1725-1743. Date of Electronic Publication: 2021 Jun 02.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't
Journal Info: Publisher: SAGE Publications Country of Publication: England NLM ID: 9212457 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1477-0334 (Electronic) Linking ISSN: 09622802 NLM ISO Abbreviation: Stat Methods Med Res Subsets: MEDLINE; PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Edgar+K%22">Edgar K</searchLink>; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.<br /><searchLink fieldCode="AU" term="%22Jackson+D%22">Jackson D</searchLink>; Statistical Innovation, Oncology R&D, AstraZeneca, AstraZeneca, Cambridge, UK.<br /><searchLink fieldCode="AU" term="%22Rhodes+K%22">Rhodes K</searchLink>; Statistical Innovation, Oncology R&D, AstraZeneca, AstraZeneca, Cambridge, UK.<br /><searchLink fieldCode="AU" term="%22Duffy+T%22">Duffy T</searchLink>; Statistical Innovation, BioPharmaceutical R&D, AstraZeneca, Gothenburg, Sweden.<br /><searchLink fieldCode="AU" term="%22Burman+CF%22">Burman CF</searchLink>; Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.<br /><searchLink fieldCode="AU" term="%22Sharples+LD%22">Sharples LD</searchLink>; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
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  Data: <searchLink fieldCode="JN" term="%229212457%22">Statistical methods in medical research</searchLink> [Stat Methods Med Res] 2021 Jul; Vol. 30 (7), pp. 1725-1743. <i>Date of Electronic Publication: </i>2021 Jun 02.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22SAGE+Publications%22">SAGE Publications </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>9212457 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1477-0334 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2209622802%22">09622802 </searchLink><i>NLM ISO Abbreviation: </i>Stat Methods Med Res <i>Subsets: </i>MEDLINE; PubMed not MEDLINE
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        Value: 10.1177/09622802211017574
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              Text: 2021 Jul
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