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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
Descripción
Sumario: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.