On testing simultaneously non-inferiority in two multiple primary endpoints and superiority in at least one of them

Biometrical Journal

Volumn 48, Issue 6, 2006, Pages 916-933

  Röhmel, Joachim ^a   Gerlinger, Christoph ^b   Benda, Norbert ^b   Läuter, Jürgen ^c  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b BAYER PHARMA AG   (Germany)

^c OTTO VON GUERICKE UNIVERSITY   (Germany)

Author keywords

Directional tests; Multiple primary endpoints; Non inferiority; Superiority in at least one endpoint

Indexed keywords

BIVARIATE; CLINICAL TRIAL; DIRECTIONAL TEST; MULTIPLE PRIMARY ENDPOINT; NON-INFERIORITY; O'BRIEN; P-VALUES; STEPS PROCEDURE; SUPERIORITY IN AT LEAST ONE ENDPOINT; TYPE-I ERROR;

STATISTICS;

EID: 33846235440     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200510289     Document Type: Article

References (22)

1. Bauer, P., Röhmel, J., Maurer, W., and Hothorn, L. (1998). Testing strategies in multi-dose experiments including active control. Statistics in Medicine 17, 2133-2146.
2. Bloch, D. A., Lai, T. L., and Tubert-Bitter, P. (2001). One-sided tests in clinical trials with multiple endpoints. Biometrics 57, 1039-1047.
3. Bloch, D. A., Lai, T. L., Su, Z., and Tubert-Bitter, P. A. combined superiority and non-inferiority approach to multiple endpoints in clinical trials. Statistics in Medicine (in preview) DOI:10.1002/sim.2611.
4. Follmann, D. (1995). Multivariate tests for multiple endpoints in clinical trials. Statistics in Medicine 14, 1163-1175.
5. Follmann, D. (1996). A simple multivariate test for one-sided alternatives. Journal of the American Statistical Association 91, 854-861.
6. Hochberg, Y. (1988). A sharper Bonferroni procedure for multiple tests of significance. Biometrika 75, 800-802.
7. Holm, S. A. (1979). A Simple Sequentially Rejective Multiple Test Procedure. Scandinavian Journal of Statistics 6, 65-70.
8. Läuter, J., Glimm, E., and Kropf. S. (1996). New Multivariate Tests for Data with an Inherent Structure. Biometrical Journal 38, 5-23.
9. Läuter, J. (1996). Exact t and F tests for analyzing clinical trials with multiple endpoints. Biometrics 52, 964-970.
10. Lehmacher, W., Wassmer, G., and Reitmeir, P. (1991). Procedures for two sample comparisons with multiple end-points controlling the experimentwise error rate. Biometrics 50, 581-583.
11. Marcus, R., Peritz, E., and Gabriel, K. R. (1976). On closed testing procedures with special reference to ordered analysis of variance. Biometrika 63, 655-660.
12. O'Brien, P. C. (1984). Procedures for comparing samples with multiple endpoints. Biometrics 40, 1079-1087.
13. Perlman, M. D. (1969). One-sided testing problems in multivariate analysis. Annals of Mathematical Statistics 40, 549-567.
14. Perlman, M. D. and Wu, L. (2004). A note on one-sided tests with multiple endpoints. Biometrics 60, 276-280.
15. Reitmeir, P. and Wassmer, G. (1996). One-sided multiple endpoint testing in two-sample comparisons. Communications in Statistics. Computation and Simulation 25, 99-117.
16. Reitmeir, P. and Wassmer, G. (1999). Resampling-based methods for the analysis of multiple endpoints in clinical trials. Statistics in Medicine 18, 3453-3462.
17. Sankoh, A. J., D'Agostino, R. B., and Huque, M. F. (2003). Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues. Statistics in Medicine 22, 3133-3150.
18. Silvapulle, M. J. (1997). A curious example involving the likelihood ratio test against one-sided alternatives, The American Statistician 51, 178-181.
19. Tamhane, A. C. and Logan, B. R. (2002). Accurate critical constants for the one-sided approximate likelihood ratio test for a normal mean vector when the covariance matrix is estimated. Biometrics 58, 650-656.
20. Tamhane, A. C. and Logan, B. R. (2004). A superiority-equivalence approach to one-sided tests on multiple end-points in clinical trials. Biometrika 91, 715-727.
21. Tang, D. I., Gnecco, C., and Geller, N. (1989). An approximate likelihood ratio test for the normal mean vector with nonnegative components with application to clinical trials. Biometrika 76, 577-583.
22. Wang, S. J. (1998). A closed procedure based on Follmann's test for the analysis of multiple endpoints. Communications in Statistics Theory and Methods 27, 2461-2480.