-
1
-
-
0037472837
-
Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics
-
D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Statistics in Medicine 2003; 22(2):169-186.
-
(2003)
Statistics in Medicine
, vol.22
, Issue.2
, pp. 169-186
-
-
D'Agostino, R.B.1
Massaro, J.M.2
Sullivan, L.M.3
-
2
-
-
84887162581
-
-
ICHExpert Working Group. Choice of control group and related issues in clinical trials E10
-
ICHExpert Working Group. Choice of control group and related issues in clinical trials E10, 2000.
-
(2000)
-
-
-
3
-
-
84887193697
-
-
CHMP. Guideline on the choice of the non-inferiority margin, London
-
CHMP. Guideline on the choice of the non-inferiority margin, London, 2005.
-
(2005)
-
-
-
4
-
-
84887164738
-
-
CPMP. Note for guidance on the clinical investigation of medicinal products indicated in the treatment of asthma, London
-
CPMP. Note for guidance on the clinical investigation of medicinal products indicated in the treatment of asthma, London, 2003.
-
(2003)
-
-
-
5
-
-
84887145394
-
-
CHMP. Guideline on clinical investigation of medicinal products indicated for the treatment of panic disorder, London
-
CHMP. Guideline on clinical investigation of medicinal products indicated for the treatment of panic disorder, London, 2005.
-
(2005)
-
-
-
6
-
-
84887148303
-
-
CHMP. Guideline on clinical investigation of medicinal products for the treatment of migraine, London
-
CHMP. Guideline on clinical investigation of medicinal products for the treatment of migraine, London, 2007.
-
(2007)
-
-
-
7
-
-
2642585618
-
Hypothesis testing in the 'gold standard' design for proving the efficacy of an experimental treatment relative to placebo and a reference
-
Koch A, Röhmel J. Hypothesis testing in the 'gold standard' design for proving the efficacy of an experimental treatment relative to placebo and a reference. Journal of Biopharmaceutical Statistics 2004; 14(2):315-325.
-
(2004)
Journal of Biopharmaceutical Statistics
, vol.14
, Issue.2
, pp. 315-325
-
-
Koch, A.1
Röhmel, J.2
-
8
-
-
0032529072
-
Therapeutic equivalence investigations: statistical considerations
-
Röhmel J. Therapeutic equivalence investigations: statistical considerations. Statistics in Medicine 1998; 17(15-16):1703-1714.
-
(1998)
Statistics in Medicine
, vol.17
, Issue.15-16
, pp. 1703-1714
-
-
Röhmel, J.1
-
9
-
-
0032716231
-
Nonparametric analysis of covariance and its role in noninferiority clinical trials
-
Koch GG, Tangen CM. Nonparametric analysis of covariance and its role in noninferiority clinical trials. Drug Information Journal 1999; 33(4):1145-1159.
-
(1999)
Drug Information Journal
, vol.33
, Issue.4
, pp. 1145-1159
-
-
Koch, G.G.1
Tangen, C.M.2
-
10
-
-
0037473218
-
Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo
-
Pigeot I, Schäfer J, Röhmel J, Hauschke D. Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo. Statistics in Medicine 2003; 22(6):883-899.
-
(2003)
Statistics in Medicine
, vol.22
, Issue.6
, pp. 883-899
-
-
Pigeot, I.1
Schäfer, J.2
Röhmel, J.3
Hauschke, D.4
-
11
-
-
2642569237
-
Tests of noninferiority via rate difference for three-arm clinical trials with placebo
-
Tang ML, Tang NS. Tests of noninferiority via rate difference for three-arm clinical trials with placebo. Journal of Biopharmaceutical Statistics 2004; 14(2):337-347.
-
(2004)
Journal of Biopharmaceutical Statistics
, vol.14
, Issue.2
, pp. 337-347
-
-
Tang, M.L.1
Tang, N.S.2
-
12
-
-
33846191097
-
Planning and analysis of three-arm non-inferiority trials with binary endpoints
-
Kieser M, Friede T. Planning and analysis of three-arm non-inferiority trials with binary endpoints. Statistics in Medicine 2007; 26(2):253-273.
-
(2007)
Statistics in Medicine
, vol.26
, Issue.2
, pp. 253-273
-
-
Kieser, M.1
Friede, T.2
-
13
-
-
39449129871
-
Assessing non-inferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity
-
Hasler M, Vonk R, Hothorn LA. Assessing non-inferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity. Statistics in Medicine 2008; 27(4):490-503.
-
(2008)
Statistics in Medicine
, vol.27
, Issue.4
, pp. 490-503
-
-
Hasler, M.1
Vonk, R.2
Hothorn, L.A.3
-
14
-
-
84971616210
-
Robust designs in noninferiority three-arm clinical trials with presence of heteroscedasticity
-
Dette H, Trampisch M, Hothorn LA. Robust designs in noninferiority three-arm clinical trials with presence of heteroscedasticity. Statistics in Biopharmaceutical Research 2009; 1(3):268-278.
-
(2009)
Statistics in Biopharmaceutical Research
, vol.1
, Issue.3
, pp. 268-278
-
-
Dette, H.1
Trampisch, M.2
Hothorn, L.A.3
-
15
-
-
84878515201
-
A generalized p-value approach for assessing noninferiority in a three-arm trial
-
Gamalo MA, Muthukumarana S, Ghosh P, Tiwari RC. A generalized p-value approach for assessing noninferiority in a three-arm trial. Statistical Methods in Medical Research 2013; 22(3):261-277.
-
(2013)
Statistical Methods in Medical Research
, vol.22
, Issue.3
, pp. 261-277
-
-
Gamalo, M.A.1
Muthukumarana, S.2
Ghosh, P.3
Tiwari, R.C.4
-
16
-
-
60249095140
-
The assessment of non-inferiority in a gold standard design with censored, exponentially distributed endpoints
-
Mielke M, Munk A, Schacht A. The assessment of non-inferiority in a gold standard design with censored, exponentially distributed endpoints. Statistics in Medicine 2008; 27(25):5093-5110.
-
(2008)
Statistics in Medicine
, vol.27
, Issue.25
, pp. 5093-5110
-
-
Mielke, M.1
Munk, A.2
Schacht, A.3
-
17
-
-
33749332490
-
A two-stage sample size recalculation procedure for placebo- and active-controlled non-inferiority trials
-
Schwartz TA, Denne JS. A two-stage sample size recalculation procedure for placebo- and active-controlled non-inferiority trials. Statistics in Medicine 2006; 25(19):3396-3406.
-
(2006)
Statistics in Medicine
, vol.25
, Issue.19
, pp. 3396-3406
-
-
Schwartz, T.A.1
Denne, J.S.2
-
18
-
-
77956295377
-
A group sequential type design for three-arm non-inferiority trials with binary endpoints
-
Li G, Gao S. A group sequential type design for three-arm non-inferiority trials with binary endpoints. Biometrical Journal 2010; 52(4):504-518.
-
(2010)
Biometrical Journal
, vol.52
, Issue.4
, pp. 504-518
-
-
Li, G.1
Gao, S.2
-
19
-
-
72849146423
-
Nonparametric non-inferiority analyses in the three-arm design with active control and placebo
-
Munzel U. Nonparametric non-inferiority analyses in the three-arm design with active control and placebo. Statistics in Medicine 2009; 28(29):3643-3656.
-
(2009)
Statistics in Medicine
, vol.28
, Issue.29
, pp. 3643-3656
-
-
Munzel, U.1
-
20
-
-
79958765718
-
Assessing noninferiority in a three-arm trial using the Bayesian approach
-
Gosh P, Nathoo FS, Gönen M, Tiwari RC. Assessing noninferiority in a three-arm trial using the Bayesian approach. Statistics in Medicine 2011; 30(15):1795-1808.
-
(2011)
Statistics in Medicine
, vol.30
, Issue.15
, pp. 1795-1808
-
-
Gosh, P.1
Nathoo, F.S.2
Gönen, M.3
Tiwari, R.C.4
-
21
-
-
29844441008
-
Establishing efficacy of a new experimental treatment in the 'gold standard' design
-
Hauschke D, Pigeot I. Establishing efficacy of a new experimental treatment in the 'gold standard' design. Biometrical Journal 2005; 47(6):782-786.
-
(2005)
Biometrical Journal
, vol.47
, Issue.6
, pp. 782-786
-
-
Hauschke, D.1
Pigeot, I.2
-
22
-
-
29844433281
-
Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design"
-
Lewis JA. Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design". Biometrical Journal 2005; 47(6):787-789.
-
(2005)
Biometrical Journal
, vol.47
, Issue.6
, pp. 787-789
-
-
Lewis, J.A.1
-
23
-
-
29844441641
-
Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design"
-
Röhmel J. Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design". Biometrical Journal 2005; 47(6):790-791.
-
(2005)
Biometrical Journal
, vol.47
, Issue.6
, pp. 790-791
-
-
Röhmel, J.1
-
24
-
-
29844440463
-
Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design"
-
Koch A. Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design". Biometrical Journal 2005; 47(6):792-793.
-
(2005)
Biometrical Journal
, vol.47
, Issue.6
, pp. 792-793
-
-
Koch, A.1
-
25
-
-
29844435529
-
Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design"
-
Mehrotra DV. Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design". Biometrical Journal 2005; 47(6):794.
-
(2005)
Biometrical Journal
, vol.47
, Issue.6
, pp. 794
-
-
Mehrotra, D.V.1
-
26
-
-
29844441007
-
Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design"
-
Hung HMJ. Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design". Biometrical Journal 2005; 47(6):795-796.
-
(2005)
Biometrical Journal
, vol.47
, Issue.6
, pp. 795-796
-
-
Hung, H.M.J.1
-
27
-
-
29844451225
-
Rejoinder to "Establishing efficacy of a new experimental treatment in the 'gold standard' design"
-
Hauschke D, Pigeot I. Rejoinder to "Establishing efficacy of a new experimental treatment in the 'gold standard' design". Biometrical Journal 2005; 47(6):797-798.
-
(2005)
Biometrical Journal
, vol.47
, Issue.6
, pp. 797-798
-
-
Hauschke, D.1
Pigeot, I.2
-
28
-
-
29844456173
-
On confidence bounds for the ratio of net differences in the "gold standard" design with reference, experimental, and placebo treatment
-
Röhmel J. On confidence bounds for the ratio of net differences in the "gold standard" design with reference, experimental, and placebo treatment. Biometrical Journal 2005; 47(6):799-806.
-
(2005)
Biometrical Journal
, vol.47
, Issue.6
, pp. 799-806
-
-
Röhmel, J.1
-
29
-
-
77955904711
-
A comparison of multiple testing procedures for the gold standard non-inferiority trial
-
Röhmel J, Pigeot I. A comparison of multiple testing procedures for the gold standard non-inferiority trial. Journal of Biopharmaceutical Statistics 2010; 20(5):911-926.
-
(2010)
Journal of Biopharmaceutical Statistics
, vol.20
, Issue.5
, pp. 911-926
-
-
Röhmel, J.1
Pigeot, I.2
-
30
-
-
78650942468
-
On the three-arm non-inferiority trial including a placebo with a prespecified margin
-
Hida E, Tango T. On the three-arm non-inferiority trial including a placebo with a prespecified margin. Statistics in Medicine 2011; 30(3):224-231.
-
(2011)
Statistics in Medicine
, vol.30
, Issue.3
, pp. 224-231
-
-
Hida, E.1
Tango, T.2
-
31
-
-
84867331953
-
Extension of three-arm non-inferiority studies to trials with multiple new treatments
-
Kwong KS, Cheung SH, Hayter AJ, Wen MJ. Extension of three-arm non-inferiority studies to trials with multiple new treatments. Statistics in Medicine 2012; 31(24):2833-2843.
-
(2012)
Statistics in Medicine
, vol.31
, Issue.24
, pp. 2833-2843
-
-
Kwong, K.S.1
Cheung, S.H.2
Hayter, A.J.3
Wen, M.J.4
-
32
-
-
84983797358
-
Step-up procedures for non-inferiority tests with multiple experimental treatments
-
Epub ahead of print] DOI: 10.1177/0962280213477767.
-
Kwong KS, Cheung SH, Hayter AJ. Step-up procedures for non-inferiority tests with multiple experimental treatments. Statistical Methods in Medical Research 2013. [Epub ahead of print] DOI: 10.1177/0962280213477767.
-
(2013)
Statistical Methods in Medical Research
-
-
Kwong, K.S.1
Cheung, S.H.2
Hayter, A.J.3
-
33
-
-
80055086038
-
Statistical strategies for the analysis of clinical trials with an experimental treatment, an active control and placebo, and a prespecified fixed non-inferiority margin for the difference in means
-
Röhmel J, Pigeot I. Statistical strategies for the analysis of clinical trials with an experimental treatment, an active control and placebo, and a prespecified fixed non-inferiority margin for the difference in means. Statistics in Medicine 2011; 30(26):3162-3164.
-
(2011)
Statistics in Medicine
, vol.30
, Issue.26
, pp. 3162-3164
-
-
Röhmel, J.1
Pigeot, I.2
-
34
-
-
80055069941
-
Response to Joachim Röhmel and Iris Pigeot
-
Hida E, Tango T. Response to Joachim Röhmel and Iris Pigeot. Statistics in Medicine 2011; 30(26):3165-3165.
-
(2011)
Statistics in Medicine
, vol.30
, Issue.26
, pp. 3165-3165
-
-
Hida, E.1
Tango, T.2
-
35
-
-
84870256039
-
A general approach for sample size calculation for the three-arm 'gold standard' non-inferiority design
-
Stucke K, Kieser M. A general approach for sample size calculation for the three-arm 'gold standard' non-inferiority design. Statistics in Medicine 2012; 31(28):3579-5396.
-
(2012)
Statistics in Medicine
, vol.31
, Issue.28
, pp. 3579-5396
-
-
Stucke, K.1
Kieser, M.2
-
36
-
-
0002676309
-
Multiple comparisons in drug clinical trials and preclinical assays: a-priori ordered hypotheses
-
In, Vollmar J (ed.). Deutscher Apotheker Verlag: Stuttgart
-
Maurer W, Hothorn LA, Lehmacher W. Multiple comparisons in drug clinical trials and preclinical assays: a-priori ordered hypotheses. In Biometrie in der chemisch-pharmazeutischen Industrie, Vollmar J (ed.). Deutscher Apotheker Verlag: Stuttgart, 1995.
-
(1995)
Biometrie in der chemisch-pharmazeutischen Industrie
-
-
Maurer, W.1
Hothorn, L.A.2
Lehmacher, W.3
-
37
-
-
54549122408
-
Compatible simultaneous lower confidence bounds for the holm procedure and other Bonferroni-based closed tests
-
Strassburger K, Bretz F. Compatible simultaneous lower confidence bounds for the holm procedure and other Bonferroni-based closed tests. Statistics in Medicine 2008; 27(24):4914-4927.
-
(2008)
Statistics in Medicine
, vol.27
, Issue.24
, pp. 4914-4927
-
-
Strassburger, K.1
Bretz, F.2
-
38
-
-
54549107976
-
Simultaneous confidence regions corresponding to Holm's step-down procedure and other closed-testing procedures
-
Guildbaud O. Simultaneous confidence regions corresponding to Holm's step-down procedure and other closed-testing procedures. Statistics in Medicine 2008; 50(5):678-692.
-
(2008)
Statistics in Medicine
, vol.50
, Issue.5
, pp. 678-692
-
-
Guildbaud, O.1
-
39
-
-
0000732463
-
A limited memory algorithm for bound constrained optimization
-
Byrd RH, Lu P, Nocedal J, Zhu C. A limited memory algorithm for bound constrained optimization. SIAM Journal on Scientific Computing 1995; 16(6):1190-1208.
-
(1995)
SIAM Journal on Scientific Computing
, vol.16
, Issue.6
, pp. 1190-1208
-
-
Byrd, R.H.1
Lu, P.2
Nocedal, J.3
Zhu, C.4
-
40
-
-
84887145303
-
-
Adaptive controlled noninferiority group sequential trials, TU Dortmund - Eldorado, Available from: ) [accessed 2 February 2012].
-
Hartung J, Knapp G. Adaptive controlled noninferiority group sequential trials, TU Dortmund - Eldorado, 2009. (Available from: http://hdl.handle.net/2003/26014) [accessed 2 February 2012].
-
(2009)
-
-
Hartung, J.1
Knapp, G.2
-
41
-
-
0032714063
-
Closed testing procedures for group sequential clinical trials with multiple endpoints
-
Tang DI, Geller NL. Closed testing procedures for group sequential clinical trials with multiple endpoints. Biometrics 1999; 55(4):1188-1192.
-
(1999)
Biometrics
, vol.55
, Issue.4
, pp. 1188-1192
-
-
Tang, D.I.1
Geller, N.L.2
-
42
-
-
0023217456
-
Approximately optimal one-parameter boundaries for group sequential trials
-
Wang SK, Tsiatis AA. Approximately optimal one-parameter boundaries for group sequential trials. Biometrics 1987; 43:193-200.
-
(1987)
Biometrics
, vol.43
, pp. 193-200
-
-
Wang, S.K.1
Tsiatis, A.A.2
-
43
-
-
0000238336
-
A simplex algorithm for function minimization
-
Nelder JA, Mead R. A simplex algorithm for function minimization. Computer Journal 1965; 7:308-313.
-
(1965)
Computer Journal
, vol.7
, pp. 308-313
-
-
Nelder, J.A.1
Mead, R.2
-
44
-
-
84887170867
-
-
CHMP. Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design, London
-
CHMP. Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design, London, 2007.
-
(2007)
-
-
-
45
-
-
0025598008
-
Group sequential designs using a family of type I error probability spending functions
-
Hwang IH, Shih WJ, De Cani JS. Group sequential designs using a family of type I error probability spending functions. Statistics in Medicine 1990; 9(12):1439-1445.
-
(1990)
Statistics in Medicine
, vol.9
, Issue.12
, pp. 1439-1445
-
-
Hwang, I.H.1
Shih, W.J.2
De Cani, J.S.3
-
46
-
-
0000785248
-
Design and analysis of group sequential tests based on the type I error spending rate function
-
Kim K, DeMets DL. Design and analysis of group sequential tests based on the type I error spending rate function. Biometrika 1987; 74(1):149-154.
-
(1987)
Biometrika
, vol.74
, Issue.1
, pp. 149-154
-
-
Kim, K.1
DeMets, D.L.2
|