Journal of the National Cancer Institute Advance Access originally published online on December 11, 2007
JNCI Journal of the National Cancer Institute 2007 99(24):1832-1835; doi:10.1093/jnci/djm283
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© Oxford University Press 2007.
NEWS |
WHEN IS SIGNIFICANT NOT IMPORTANT?
Finding Clinical Meaning in Cancer Data
| The first 150 words of the full text of this article appear below. |
Researchers studying treatments for advanced pancreatic cancer recently showed that overall survival "was significantly prolonged" by combining erlotinib and gemcitabine rather than giving gemcitabine alone. The study was statistically significant at the 95% confidence level and may influence future treatment decisions.
But there is one small problem. Giving erlotinib and gemcitabine together added only 10 days to the average patient's life, according to the study in the May 20 issue of Journal of Clinical Oncology. Plus, the combination increased the side effects patients experienced, most notably diarrhea. Those facts raise an important question—do 10 extra days of life constitute a meaningful or desirable increase, given the months of reduced quality of life (QOL) that patients might endure to get them?
This example illustrates that statistical significance and clinical importance—the degree of improvement a new treatment must make for it to be clinically meaningful—are different concepts. Statistical significance at the
QOL Base
Absolute Risk and NNT Matters
Big Trials, Little Results
Significant, But Not Clinically