-
1
-
-
0025805329
-
Multiple testing in clinical trials
-
Bauer P. Multiple testing in clinical trials. Stat Med 1991; 10: 871-89.
-
(1991)
Stat Med
, vol.10
, pp. 871-889
-
-
Bauer, P.1
-
2
-
-
0025967243
-
Multiple comparisons in over-The-counter drug clinical trials with both positive and placebo controls
-
D'Agostino RB, Heeren TC. Multiple comparisons in over-the-counter drug clinical trials with both positive and placebo controls. Stat Med 1991; 10: 1-6.
-
(1991)
Stat Med
, vol.10
, pp. 1-6
-
-
D'Agostino, R.B.1
Heeren, T.C.2
-
3
-
-
0027171587
-
Strategies for dealing with multiple treatment comparisons in confirmatory clinical trials
-
D'Agostino RB, Massaro J, Kwan H, Cabral H. Strategies for dealing with multiple treatment comparisons in confirmatory clinical trials. Drug Inf J 1993; 27: 625-41.
-
(1993)
Drug Inf J
, vol.27
, pp. 625-641
-
-
D'Agostino, R.B.1
Massaro, J.2
Kwan, H.3
Cabral, H.4
-
4
-
-
0030670944
-
Some comments on frequently used multiple endpoint adjustment methods in clinical trials
-
Sankoh AJ, Huque MF, Dubey SD. Some comments on frequently used multiple endpoint adjustment methods in clinical trials. Stat Med 1997; 16: 2529-42.
-
(1997)
Stat Med
, vol.16
, pp. 2529-2542
-
-
Sankoh, A.J.1
Huque, M.F.2
Dubey, S.D.3
-
5
-
-
84874971341
-
Key multiplicity issues in clinical drug development
-
Dmitrienko A, D'Agostino RB Sr, Huque MF. Key multiplicity issues in clinical drug development. Stat Med 2013; 32: 1079-111.
-
(2013)
Stat Med
, vol.32
, pp. 1079-1111
-
-
Dmitrienko, A.1
D'Agostino, R.B.2
Huque, M.F.3
-
6
-
-
84889653538
-
Multiplicity issues in clinical trials with multiple objectives
-
Huque MF, Dmitrienko A, D'Agostino RB. Multiplicity issues in clinical trials with multiple objectives. Stat Biopharm Res 2013; 5: 321-37.
-
(2013)
Stat Biopharm Res
, vol.5
, pp. 321-337
-
-
Huque, M.F.1
Dmitrienko, A.2
D'Agostino, R.B.3
-
9
-
-
85042596033
-
-
December
-
European Medicines Agency. Guideline on multiplicity issues in clinical trials. December 2016 (http://www .ema .europa .eu/docs/en-GB/document-library/Scientific -guideline/2017/03/WC500224998 .pdf).
-
(2016)
Guideline on Multiplicity Issues in Clinical Trials
-
-
-
10
-
-
84887241280
-
Traditional multiplicity adjustment methods in clinical trials
-
Dmitrienko A, D'Agostino R Sr. Traditional multiplicity adjustment methods in clinical trials. Stat Med 2013; 32: 5172-218.
-
(2013)
Stat Med
, vol.32
, pp. 5172-5218
-
-
Dmitrienko, A.1
D'Agostino, R.2
-
11
-
-
33846460001
-
Multiple co-primary endpoints: Medical and statistical solutions: A report from the multiple endpoints expert team of the Pharmaceutical Research and Man- ufacturers of America
-
Offen W, Chuang-Stein C, Dmitrienko A, et al. Multiple co-primary endpoints: Medical and statistical solutions: A report from the multiple endpoints expert team of the Pharmaceutical Research and Man- ufacturers of America. Drug Inf J 2007; 41: 31-46.
-
(2007)
Drug Inf J
, vol.41
, pp. 31-46
-
-
Offen, W.1
Chuang-Stein, C.2
Dmitrienko, A.3
-
12
-
-
60749097128
-
Discussion of some controversial multiple testing problems in regulatory applications
-
Chuang-Stein C, Dmitrienko A, Offen W. Discussion of "Some controversial multiple testing problems in regulatory applications." J Biopharm Stat 2009; 19: 14-21.
-
(2009)
J Biopharm Stat
, vol.19
, pp. 14-21
-
-
Chuang-Stein, C.1
Dmitrienko, A.2
Offen, W.3
-
13
-
-
27744573697
-
Combining multiple comparisons and modeling techniques in dose-response studies
-
Bretz F, Pinheiro JC, Branson M. Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics 2005; 61: 738-48.
-
(2005)
Biometrics
, vol.61
, pp. 738-748
-
-
Bretz, F.1
Pinheiro, J.C.2
Branson, M.3
-
14
-
-
2942527313
-
Use of the false discovery rate for evaluating clinical safety data
-
Mehrotra DV, Heyse JF. Use of the false discovery rate for evaluating clinical safety data. Stat Methods Med Res 2004; 13: 227-38.
-
(2004)
Stat Methods Med Res
, vol.13
, pp. 227-238
-
-
Mehrotra, D.V.1
Heyse, J.F.2
-
15
-
-
85056073689
-
Multiple testing methodology
-
In: Dmitrienko A, Tamhane AC, Bretz F, eds. New York: Chapman and Hall/CRC Press
-
Dmitrienko A, Bretz F, Westfall PH, et al. Multiple testing methodology. In: Dmitrienko A, Tamhane AC, Bretz F, eds. Multiple testing problems in pharmaceutical statistics. New York: Chapman and Hall/CRC Press, 2009: 35-98.
-
(2009)
Multiple Testing Problems in Pharmaceutical Statistics
, pp. 35-98
-
-
Dmitrienko, A.1
Bretz, F.2
Westfall, P.H.3
-
16
-
-
0034732220
-
Controlling alpha in a clinical trial: The case for secondary endpoints
-
D'Agostino RB Sr. Controlling alpha in a clinical trial: The case for secondary endpoints. Stat Med 2000; 19: 763-6.
-
(2000)
Stat Med
, vol.19
, pp. 763-766
-
-
D'Agostino, R.B.1
-
17
-
-
84889637703
-
Multiplicity problems in clinical trials: A regulatory perspective
-
In: Dmitrienko A, Tamhane AC, Bretz F, eds. . New York: Chapman & Hall/CRC Press
-
Huque MF, Rohmel J. Multiplicity problems in clinical trials: A regulatory perspective. In: Dmitrienko A, Tamhane AC, Bretz F, eds. Multiple testing problems in pharmaceutical statistics. New York: Chapman & Hall/CRC Press, 2010: 1-34.
-
(2010)
Multiple Testing Problems in Pharmaceutical Statistics
, pp. 1-34
-
-
Huque, M.F.1
Rohmel, J.2
-
18
-
-
85056039511
-
Gatekeeping procedures in clinical trials
-
In: Dmitrienko A, Tamhane AC, Bretz F, eds. New York: Chapman and Hall/CRC Press
-
Dmitrienko A, Tamhane AC. Gatekeeping procedures in clinical trials. In: Dmitrienko A, Tamhane AC, Bretz F, eds. Multiple testing problems in pharmaceutical statistics. New York: Chapman and Hall/CRC Press, 2009: 165-91.
-
(2009)
Multiple Testing Problems in Pharmaceutical Statistics
, pp. 165-191
-
-
Dmitrienko, A.1
Tamhane, A.C.2
-
19
-
-
84939268682
-
Use of composite endpoints in clinical trials
-
Sankoh AJ, Li H, D'Agostino RB Sr. Use of composite endpoints in clinical trials. Stat Med 2014; 33: 4709-14.
-
(2014)
Stat Med
, vol.33
, pp. 4709-4714
-
-
Sankoh, A.J.1
Li, H.2
D'Agostino, R.B.3
-
20
-
-
84872078210
-
Abiraterone in metastatic prostate cancer without previous chemotherapy
-
Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013; 368: 138-48.
-
(2013)
N Engl J Med
, vol.368
, pp. 138-148
-
-
Ryan, C.J.1
Smith, M.R.2
De Bono, J.S.3
-
21
-
-
84904871070
-
Enzalutamide in metastatic prostate cancer before chemotherapy
-
Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014; 371: 424-33.
-
(2014)
N Engl J Med
, vol.371
, pp. 424-433
-
-
Beer, T.M.1
Armstrong, A.J.2
Rathkopf, D.E.3
-
23
-
-
80052477010
-
Lurasidone in the treatment of schizophrenia: A randomized, double-blind, placebo- And olanzapine-controlled study
-
Meltzer HY, Cucchiaro J, Silva R, et al. Lurasidone in the treatment of schizophrenia: A randomized, double-blind, placebo- And olanzapine-controlled study. Am J Psychiatry 2011; 168: 957-67.
-
(2011)
Am J Psychiatry
, vol.168
, pp. 957-967
-
-
Meltzer, H.Y.1
Cucchiaro, J.2
Silva, R.3
-
24
-
-
84875270413
-
Lurasidone for the treatment of acutely psychotic patients with schizophrenia: A 6-week, randomized, placebo-controlled study
-
Nasrallah HA, Silva R, Phillips D, et al. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: A 6-week, randomized, placebo-controlled study. J Psychiatr Res 2013; 47: 670-7.
-
(2013)
J Psychiatr Res
, vol.47
, pp. 670-677
-
-
Nasrallah, H.A.1
Silva, R.2
Phillips, D.3
-
25
-
-
79957440872
-
A mixture gatekeeping procedure based on the Hommel test for clinical trial applications
-
Brechenmacher T, Xu J, Dmitrienko A, Tamhane AC. A mixture gatekeeping procedure based on the Hommel test for clinical trial applications. J Biopharm Stat 2011; 21: 748-67.
-
(2011)
J Biopharm Stat
, vol.21
, pp. 748-767
-
-
Brechenmacher, T.1
Xu, J.2
Dmitrienko, A.3
Tamhane, A.C.4
-
26
-
-
79956103462
-
Mixtures of multiple testing procedures for gatekeeping applications in clinical trials
-
Dmitrienko A, Tamhane AC. Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Stat Med 2011; 30: 1473-88.
-
(2011)
Stat Med
, vol.30
, pp. 1473-1488
-
-
Dmitrienko, A.1
Tamhane, A.C.2
-
27
-
-
84876988215
-
General theory of mixture procedures for gatekeeping
-
Dmitrienko A, Tamhane AC. General theory of mixture procedures for gatekeeping. Biom J 2013; 55: 402-19.
-
(2013)
Biom J
, vol.55
, pp. 402-419
-
-
Dmitrienko, A.1
Tamhane, A.C.2
-
28
-
-
0037160968
-
Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): A randomised trial against atenolol
-
Dahlof B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): A randomised trial against atenolol. Lancet 2002; 359: 995-1003.
-
(2002)
Lancet
, vol.359
, pp. 995-1003
-
-
Dahlof, B.1
Devereux, R.B.2
Kjeldsen, S.E.3
-
29
-
-
79957514914
-
Addressing multiplicity issues of a composite endpoint and its components in clinical trials
-
Huque MF, Alosh M, Bhore R. Addressing multiplicity issues of a composite endpoint and its components in clinical trials. J Biopharm Stat 2011; 21: 610-34.
-
(2011)
J Biopharm Stat
, vol.21
, pp. 610-634
-
-
Huque, M.F.1
Alosh, M.2
Bhore, R.3
-
30
-
-
84980343984
-
Tutorial in biostatistics: Data-driven subgroup identification and analysis in clinical trials
-
Lipkovich I, Dmitrienko A, D'Agostino RB Sr. Tutorial in biostatistics: Data-driven subgroup identification and analysis in clinical trials. Stat Med 2017; 36: 136-96.
-
(2017)
Stat Med
, vol.36
, pp. 136-196
-
-
Lipkovich, I.1
Dmitrienko, A.2
D'Agostino, R.B.3
-
31
-
-
84873817347
-
A statistical framework for decision making in confirmatory multipopulation tailoring clinical trials
-
Millen BA, Dmitrienko A, Ruberg S, Shen L. A statistical framework for decision making in confirmatory multipopulation tailoring clinical trials. Drug Inf J 2012; 46: 647-56.
-
(2012)
Drug Inf J
, vol.46
, pp. 647-656
-
-
Millen, B.A.1
Dmitrienko, A.2
Ruberg, S.3
Shen, L.4
-
32
-
-
70349475409
-
SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following nonprogression with first-line platinum-based chemotherapy in patients with advanced NSCLC
-
abstract
-
Cappuzzo F, Ciuleanu T, Stelmakh L, et al. SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following nonprogression with first-line platinum-based chemotherapy in patients with advanced NSCLC. J Clin Oncol 2009; 27: 8001. abstract.
-
(2009)
J Clin Oncol
, vol.27
, pp. 8001
-
-
Cappuzzo, F.1
Ciuleanu, T.2
Stelmakh, L.3
-
33
-
-
84981709094
-
Extended thromboprophylaxis with betrixaban in acutely ill medical patients
-
Cohen AT, Harrington RA, Goldhaber SZ, et al. Extended thromboprophylaxis with betrixaban in acutely ill medical patients. N Engl J Med 2016; 375: 534-44.
-
(2016)
N Engl J Med
, vol.375
, pp. 534-544
-
-
Cohen, A.T.1
Harrington, R.A.2
Goldhaber, S.Z.3
|