JOURNAL ARTICLE

Randomization as a basis for inference in noninferiority trials

Brian L Wiens
Pharmaceutical Statistics 2006, 5 (4): 265-71
17128425
Noninferiority testing in clinical trials is commonly understood in a Neyman-Pearson framework, and has been discussed in a Bayesian framework as well. In this paper, we discuss noninferiority testing in a Fisherian framework, in which the only assumption necessary for inference is the assumption of randomization of treatments to study subjects. Randomization plays an important role in not only the design but also the analysis of clinical trials, no matter the underlying inferential field. The ability to utilize permutation tests depends on assumptions around exchangeability, and we discuss the possible uses of permutation tests in active control noninferiority analyses. The other practical implications of this paper are admittedly minor but lead to better understanding of the historical and philosophical development of active control noninferiority testing. The conclusion may also frame discussion of other complicated issues in noninferiority testing, such as the role of an intention to treat analysis.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
17128425
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"