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Survival analysis, more than meets the eye

The log-rank test is a cornerstone of phase III oncology clinical trials. However, there are at least three different mathematical procedures that can be named the log-rank test and two of them are widely used by commercial statistical programs. Consequently, different P values can be obtained. In t...

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Detalles Bibliográficos
Autores principales: Lucijanic, Marko, Skelin, Marko, Lucijanic, Tomo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Croatian Society of Medical Biochemistry and Laboratory Medicine 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5382852/
https://www.ncbi.nlm.nih.gov/pubmed/28392721
http://dx.doi.org/10.11613/BM.2017.002
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author Lucijanic, Marko
Skelin, Marko
Lucijanic, Tomo
author_facet Lucijanic, Marko
Skelin, Marko
Lucijanic, Tomo
author_sort Lucijanic, Marko
collection PubMed
description The log-rank test is a cornerstone of phase III oncology clinical trials. However, there are at least three different mathematical procedures that can be named the log-rank test and two of them are widely used by commercial statistical programs. Consequently, different P values can be obtained. In the case of a borderline statistical significance, this can mean the difference between the evidence (significant P value) and merely an observation. Since all three methods can be reported under the same name, space for possible data manipulation occurs. This should be of a particular concern in a drug regulatory context. Randomized clinical trials with borderline significant results should perhaps be required to report P values calculated by all three methods, in order to properly evaluate drug efficacy. An interactive MS Excel spreadsheet that uses all three logrank test variants is prepared as a supplementary file accompanying this article. Association of high grade of bone marrow fibrosis with poor outcome in patients with myelofibrosis is used as an example.
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spelling pubmed-53828522017-04-07 Survival analysis, more than meets the eye Lucijanic, Marko Skelin, Marko Lucijanic, Tomo Biochem Med (Zagreb) Lessons in Biostatistics The log-rank test is a cornerstone of phase III oncology clinical trials. However, there are at least three different mathematical procedures that can be named the log-rank test and two of them are widely used by commercial statistical programs. Consequently, different P values can be obtained. In the case of a borderline statistical significance, this can mean the difference between the evidence (significant P value) and merely an observation. Since all three methods can be reported under the same name, space for possible data manipulation occurs. This should be of a particular concern in a drug regulatory context. Randomized clinical trials with borderline significant results should perhaps be required to report P values calculated by all three methods, in order to properly evaluate drug efficacy. An interactive MS Excel spreadsheet that uses all three logrank test variants is prepared as a supplementary file accompanying this article. Association of high grade of bone marrow fibrosis with poor outcome in patients with myelofibrosis is used as an example. Croatian Society of Medical Biochemistry and Laboratory Medicine 2017-02-15 2017-02-15 /pmc/articles/PMC5382852/ /pubmed/28392721 http://dx.doi.org/10.11613/BM.2017.002 Text en
spellingShingle Lessons in Biostatistics
Lucijanic, Marko
Skelin, Marko
Lucijanic, Tomo
Survival analysis, more than meets the eye
title Survival analysis, more than meets the eye
title_full Survival analysis, more than meets the eye
title_fullStr Survival analysis, more than meets the eye
title_full_unstemmed Survival analysis, more than meets the eye
title_short Survival analysis, more than meets the eye
title_sort survival analysis, more than meets the eye
topic Lessons in Biostatistics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5382852/
https://www.ncbi.nlm.nih.gov/pubmed/28392721
http://dx.doi.org/10.11613/BM.2017.002
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