TY - JOUR
T1 - Continuity Correction for the Laster-Johnson-Kotler Noninferiority Asymptotic Statistical Test for 2 Independent Proportions
AU - Sotres-Ramos, David
AU - Castillo-Tzec, Yoni
AU - Almendra-Arao, Félix
PY - 2013/1
Y1 - 2013/1
N2 - Noninferiority asymptotic statistical tests are frequently used in clinical trials. The "at least as good as" criterion was introduced by Lasteret alin 2006 for dichotomous data. In this approach (Laster-Johnson-Kotler [LJK]), the margin of noninferiority is taken as a percentage of the control response rather than a fixed difference. The procedure is seen to be more efficient than the fixed margin approach, yielding smaller sample sizes. Also, the procedure offers several advantages in the design, statistical efficiency, and interpretability of noninferiority trials. However, the LJK procedure has a disadvantage in that its size is much greater than the required nominal significance level (α). In this paper, by using a continuity correction factor, we have adjusted this procedure to solve this drawback.
AB - Noninferiority asymptotic statistical tests are frequently used in clinical trials. The "at least as good as" criterion was introduced by Lasteret alin 2006 for dichotomous data. In this approach (Laster-Johnson-Kotler [LJK]), the margin of noninferiority is taken as a percentage of the control response rather than a fixed difference. The procedure is seen to be more efficient than the fixed margin approach, yielding smaller sample sizes. Also, the procedure offers several advantages in the design, statistical efficiency, and interpretability of noninferiority trials. However, the LJK procedure has a disadvantage in that its size is much greater than the required nominal significance level (α). In this paper, by using a continuity correction factor, we have adjusted this procedure to solve this drawback.
KW - Laster-Johnson-Kotler test
KW - continuity correction
KW - dichotomous data
KW - noninferiority
KW - test size
UR - http://www.scopus.com/inward/record.url?scp=84877346901&partnerID=8YFLogxK
U2 - 10.1177/2168479012469948
DO - 10.1177/2168479012469948
M3 - Artículo
SN - 2168-4790
VL - 47
SP - 65
EP - 69
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 1
ER -