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Hazard ratios in cancer clinical trials—a primer

Abstract

The increase and diversity of clinical trial data has resulted in a greater reliance on statistical analyses to discern value. Assessing differences between two similar survival curves can pose a challenge for those without formal training in statistical interpretation; therefore, there has been an increased reliance on hazard ratios often to the exclusion of more-traditional survival measures. However, because a hazard ratio lacks dimensions it can only inform the reader about the reliability and uniformity of the data. It does not provide practitioners with quantitative values they can use, nor does it provide information they can discuss with patients. Motivated by a non-scientific poll of oncologists in training and those with board certification that suggested only a limited understanding of the derivation of hazard ratios we undertook this presentation of hazard ratios: a measure of treatment efficacy that is increasingly used and often misused.

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Figure 1: The use of the term hazard ratio in abstracts.
Figure 2: Kaplan–Meier plot of hypothetical clinical trial.
Figure 3: Kaplan–Meier plot of two studies that led to registration of the respective drugs in renal cell carcinoma.
Figure 4: Graphical presentation of hypothetical clinical trial data (Table 3) demonstrates how the hazard rate is calculated and how this rate can be used to calculate the hazard ratio.

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Acknowledgements

K. B. Blagoev would like to acknowledge that this work was supported in part by the National Science Foundation. Any opinion, finding, conclusions or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the National Science Foundation.

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All authors contributed to researching the data for the article and had a substantial contribution to discussion of the content. K. B. Blagoev and T. Fojo wrote the manuscript and reviewed and edited it before submission.

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Correspondence to Tito Fojo.

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The authors declare no competing financial interests.

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Blagoev, K., Wilkerson, J. & Fojo, T. Hazard ratios in cancer clinical trials—a primer. Nat Rev Clin Oncol 9, 178–183 (2012). https://doi.org/10.1038/nrclinonc.2011.217

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