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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ISSN:1477-0334
DOI:10.1177/09622802211017574