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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...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Croatian Society of Medical Biochemistry and Laboratory Medicine
2017
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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. |
format | Online Article Text |
id | pubmed-5382852 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Croatian Society of Medical Biochemistry and Laboratory Medicine |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT lucijanicmarko survivalanalysismorethanmeetstheeye AT skelinmarko survivalanalysismorethanmeetstheeye AT lucijanictomo survivalanalysismorethanmeetstheeye |