Journal of the National Cancer Institute Advance Access originally published online on November 27, 2007
JNCI Journal of the National Cancer Institute 2007 99(23):1746-1748; doi:10.1093/jnci/djm258
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© Oxford University Press 2007.
NEWS |
READERS BEWARE?
Trend Toward Noninferiority Trials May Mean More Difficult Interpretation of Trial Results
| The first 150 words of the full text of this article appear below. |
The number of noninferiority trials in oncology is on the rise, and the trend will probably continue as the number of approved drugs increases. Experts warn that this shift from testing superiority to noninferiority will make interpreting trial results more difficult. Some researchers even question the value of dedicating limited resources just to show that a new drug is no worse than one already in use.
Most oncology trials remain superiority trials, which are designed to establish that a new treatment is outright better than the existing therapy. The increased use of noninferiority trials, which are designed to establish that the new therapy is no worse than the existing one, means that researchers and clinicians need to become more familiar with the approach, one that experts warn is not always intuitive—or properly used.
There is a perception among some clinicians and researchers that pharmaceutical companies use noninferiority trials as a
Choosing the Right Design
Getting to the Statistics
Is Noninferiority the Question?