Details
| Original language | English |
|---|---|
| Pages (from-to) | 1720-1729 |
| Number of pages | 10 |
| Journal | Statistics in medicine |
| Volume | 32 |
| Issue number | 10 |
| Publication status | Published - 21 Sept 2012 |
Abstract
We discuss the analysis of non-inferiority trials based on a multi-armed design with multiple correlated endpoints. We consider five different scenarios: (1) global non-inferiority; (2) non-inferiority for subsets of comparisons; (3) global non-inferiority for a treatment group; (4) global non-inferiority for an endpoint; and (5) local non-inferiority. We describe and compare related approaches, which are based on the union-intersection and intersection-union test principles - alone and in combination. Because non-inferiority thresholds for many differently scaled endpoints are rarely available in practice, the approaches described focus on the estimation of simultaneous confidence limits and their post hoc interpretation on non-inferiority. We discuss and demonstrate pros and cons by means of a real data example.
Keywords
- Intersection-union test, Many-to-one comparison, Multiple endpoints, Simultaneous confidence intervals, Union-intersection test
ASJC Scopus subject areas
- Medicine(all)
- Epidemiology
- Mathematics(all)
- Statistics and Probability
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In: Statistics in medicine, Vol. 32, No. 10, 21.09.2012, p. 1720-1729.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Simultaneous confidence intervals on multivariate non-inferiority
AU - Hasler, M.
AU - Hothorn, L. A.
PY - 2012/9/21
Y1 - 2012/9/21
N2 - We discuss the analysis of non-inferiority trials based on a multi-armed design with multiple correlated endpoints. We consider five different scenarios: (1) global non-inferiority; (2) non-inferiority for subsets of comparisons; (3) global non-inferiority for a treatment group; (4) global non-inferiority for an endpoint; and (5) local non-inferiority. We describe and compare related approaches, which are based on the union-intersection and intersection-union test principles - alone and in combination. Because non-inferiority thresholds for many differently scaled endpoints are rarely available in practice, the approaches described focus on the estimation of simultaneous confidence limits and their post hoc interpretation on non-inferiority. We discuss and demonstrate pros and cons by means of a real data example.
AB - We discuss the analysis of non-inferiority trials based on a multi-armed design with multiple correlated endpoints. We consider five different scenarios: (1) global non-inferiority; (2) non-inferiority for subsets of comparisons; (3) global non-inferiority for a treatment group; (4) global non-inferiority for an endpoint; and (5) local non-inferiority. We describe and compare related approaches, which are based on the union-intersection and intersection-union test principles - alone and in combination. Because non-inferiority thresholds for many differently scaled endpoints are rarely available in practice, the approaches described focus on the estimation of simultaneous confidence limits and their post hoc interpretation on non-inferiority. We discuss and demonstrate pros and cons by means of a real data example.
KW - Intersection-union test
KW - Many-to-one comparison
KW - Multiple endpoints
KW - Simultaneous confidence intervals
KW - Union-intersection test
UR - http://www.scopus.com/inward/record.url?scp=84876454778&partnerID=8YFLogxK
U2 - 10.1002/sim.5633
DO - 10.1002/sim.5633
M3 - Article
C2 - 22996204
AN - SCOPUS:84876454778
VL - 32
SP - 1720
EP - 1729
JO - Statistics in medicine
JF - Statistics in medicine
SN - 0277-6715
IS - 10
ER -