Review article

https://doi.org/10.11613/BM.2017.002

Survival analysis, more than meets the eye

Marko Lucijanic orcid.org/0000-0002-1372-2040 ; Hematology Department, University Hospital Dubrava, Zagreb, Croatia
Marko Skelin orcid.org/0000-0003-2762-3139 ; Pharmacy Department, General Hospital Šibenik, Šibenik, Croatia
Tomo Lucijanic Lucijanic ; Endocrinology, diabetes and metabolism disorders Department, University Hospital Dubrava, Zagreb, Croatia

Abstract

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.

Keywords

statistics; clinical trial; survival analysis; primary myelofibrosis; software

Hrčak ID:

176126

URI

https://hrcak.srce.hr/176126

Publication date:

15.2.2017.

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