Survival analysis, more than meets the eye

Biochem Med (Zagreb). 2017 Feb 15;27(1):14-18. doi: 10.11613/BM.2017.002.

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

Publication types

  • Review

MeSH terms

  • Clinical Trials, Phase III as Topic / statistics & numerical data*
  • Humans
  • Models, Statistical*
  • Primary Myelofibrosis / mortality*
  • Prognosis
  • Randomized Controlled Trials as Topic / statistics & numerical data*
  • Survival Analysis