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Tytuł:
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The generalized inference on the ratio of mean differences for fraction retention noninferiority hypothesis.
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Autorzy:
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Hsieh HN; Department of Statistics and Information Science, Fu Jen Catholic University, New Taipei City, Taiwan.; Office of Institutional Research, Fu Jen Catholic University, New Taipei City, Taiwan.
Lu HY; Department of Statistics and Information Science, Fu Jen Catholic University, New Taipei City, Taiwan.
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Źródło:
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PloS one [PLoS One] 2020 Jun 09; Vol. 15 (6), pp. e0234432. Date of Electronic Publication: 2020 Jun 09 (Print Publication: 2020).
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Typ publikacji:
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Journal Article
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Język:
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English
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Imprint Name(s):
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Original Publication: San Francisco, CA : Public Library of Science
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MeSH Terms:
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Data Interpretation, Statistical*
Models, Statistical*
Research Design*
Treatment Outcome*
Drug Development/*methods
Antimetabolites, Antineoplastic/therapeutic use ; Capecitabine/therapeutic use ; Computer Simulation ; Equivalence Trials as Topic ; Humans ; Neoplasms/drug therapy
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References:
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Stat Med. 2003 Jan 30;22(2):239-64. (PMID: 12520560)
Stat Med. 2008 May 10;27(10):1762-76. (PMID: 17968858)
Stat Med. 2008 Jan 30;27(2):224-42. (PMID: 17139702)
Ann Intern Med. 2000 Sep 19;133(6):455-63. (PMID: 10975964)
N Engl J Med. 1994 Aug 11;331(6):394-8. (PMID: 8028622)
J Biopharm Stat. 2013 Mar 11;23(2):346-60. (PMID: 23437943)
Control Clin Trials. 2002 Feb;23(1):15-28. (PMID: 11852161)
J Biopharm Stat. 2006;16(2):151-64. (PMID: 16584064)
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Substance Nomenclature:
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0 (Antimetabolites, Antineoplastic)
6804DJ8Z9U (Capecitabine)
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Entry Date(s):
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Date Created: 20200610 Date Completed: 20200828 Latest Revision: 20200828
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Update Code:
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20240104
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PubMed Central ID:
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PMC7282653
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DOI:
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10.1371/journal.pone.0234432
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PMID:
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32516350
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The fraction retention non-inferiority hypothesis is often measured for the ratio of the effects of a new treatment to those of the control in medical research. However, the fraction retention non-inferiority test that the new treatment maintains the efficacy of control can be affected by the nuisance parameters. Herein, a heuristic procedure for testing the fraction retention non-inferiority hypothesis is proposed based on the generalized p-value (GPV) under normality assumption and heteroskedasticity. Through the simulation study, it is demonstrated that, the performance of the GPV-based method not only adequately controls the type I error rate at the nominal level but also is uniformly more powerful than the ratio test, Rothmann's and Wang's tests, the comparable extant methods. Finally, we illustrate the proposed method by employing a real example.
Competing Interests: The authors have declared that no competing interests exist.
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