Details
| Original language | English |
|---|---|
| Pages (from-to) | 490-503 |
| Number of pages | 14 |
| Journal | Statistics in medicine |
| Volume | 27 |
| Issue number | 4 |
| Publication status | Published - 12 Sept 2007 |
Abstract
In this paper, we describe an adjusted method to facilitate non-inferiority tests in a three-arm design. While the methodology is readily available in the situation of homogeneous group variances, the adjusted method will also maintain the α-level in the presence of heteroscedasticity. We propose explicit criteria for an optimal allocation. Depending on the pattern of heterogeneity, remarkably unbalanced designs are power optimal. We will apply the method to a randomized clinical trial and a toxicological experiment.
Keywords
- Fieller's condifence interval, Heteroscedasticity, Non-inferiority, Optimal allocation, Three-arm trial
ASJC Scopus subject areas
- Medicine(all)
- Epidemiology
- Mathematics(all)
- Statistics and Probability
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In: Statistics in medicine, Vol. 27, No. 4, 12.09.2007, p. 490-503.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Assessing non-inferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity
AU - Hasler, Mario
AU - Vonk, Richardus
AU - Hothorn, Ludwig A.
PY - 2007/9/12
Y1 - 2007/9/12
N2 - In this paper, we describe an adjusted method to facilitate non-inferiority tests in a three-arm design. While the methodology is readily available in the situation of homogeneous group variances, the adjusted method will also maintain the α-level in the presence of heteroscedasticity. We propose explicit criteria for an optimal allocation. Depending on the pattern of heterogeneity, remarkably unbalanced designs are power optimal. We will apply the method to a randomized clinical trial and a toxicological experiment.
AB - In this paper, we describe an adjusted method to facilitate non-inferiority tests in a three-arm design. While the methodology is readily available in the situation of homogeneous group variances, the adjusted method will also maintain the α-level in the presence of heteroscedasticity. We propose explicit criteria for an optimal allocation. Depending on the pattern of heterogeneity, remarkably unbalanced designs are power optimal. We will apply the method to a randomized clinical trial and a toxicological experiment.
KW - Fieller's condifence interval
KW - Heteroscedasticity
KW - Non-inferiority
KW - Optimal allocation
KW - Three-arm trial
UR - http://www.scopus.com/inward/record.url?scp=39449129871&partnerID=8YFLogxK
U2 - 10.1002/sim.3052
DO - 10.1002/sim.3052
M3 - Article
C2 - 17853384
AN - SCOPUS:39449129871
VL - 27
SP - 490
EP - 503
JO - Statistics in medicine
JF - Statistics in medicine
SN - 0277-6715
IS - 4
ER -