-
1
-
-
84926517764
-
Center for drug evaluation and research and center for biologics evaluation and research. FDA guidance for industry non-inferiority clinical trials
-
US Department of Health and Human Sciences Food and Drug Administration., March .
-
US Department of Health and Human Sciences Food and Drug Administration. Center for drug evaluation and research and center for biologics evaluation and research. FDA guidance for industry non-inferiority clinical trials, March 2010.
-
(2010)
-
-
-
2
-
-
84926518775
-
Statistical principles for clinical trials (ICH E 9)
-
International Conference on Harmonization., Food and Drug Administration, DSSH, Febuary.
-
International Conference on Harmonization. Statistical principles for clinical trials (ICH E 9), Food and Drug Administration, DSSH, Febuary 1998.
-
(1998)
-
-
-
3
-
-
0020308864
-
Proving the null hypothesis' in clinical trials
-
Blackwelder WC. Proving the null hypothesis' in clinical trials. Controlled Clinical Trials 1982; 3:345-353.
-
(1982)
Controlled Clinical Trials
, vol.3
, pp. 345-353
-
-
Blackwelder, W.C.1
-
4
-
-
0037445366
-
Therapeutic equivalency: fallacies and falsification
-
Garrett AD. Therapeutic equivalency: fallacies and falsification. Statistics in Medicine 2003; 22:741-762.
-
(2003)
Statistics in Medicine
, vol.22
, pp. 741-762
-
-
Garrett, A.D.1
-
5
-
-
0037472837
-
Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics
-
D'Agostino RB. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Statistics in Medicine 2003; 22:169-186.
-
(2003)
Statistics in Medicine
, vol.22
, pp. 169-186
-
-
D'Agostino, R.B.1
-
6
-
-
80054812743
-
Challenges in the design and analysis of non-inferiority trials: a case study
-
Durkalski V, Silbergleit R, Lowenstein D. Challenges in the design and analysis of non-inferiority trials: a case study. Clinical Trials 2011; 0:1-8.
-
(2011)
Clinical Trials
, vol.0
, pp. 1-8
-
-
Durkalski, V.1
Silbergleit, R.2
Lowenstein, D.3
-
7
-
-
0017643592
-
Significance testing to establish equivalence between treatments, with special reference to data in the form of 2x2 tables
-
Dunnett CW, Gent M. Significance testing to establish equivalence between treatments, with special reference to data in the form of 2x2 tables. Biometrics 1977; 33(4):593-602.
-
(1977)
Biometrics
, vol.33
, Issue.4
, pp. 593-602
-
-
Dunnett, C.W.1
Gent, M.2
-
8
-
-
84855936105
-
Improper analysis of trials randomised using stratified blocks or minimisation
-
Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Statistics in Medicine 2012; 31:328-340.
-
(2012)
Statistics in Medicine
, vol.31
, pp. 328-340
-
-
Kahan, B.C.1
Morris, T.P.2
-
9
-
-
77952827491
-
A theory for testing hypotheses under covariate-adaptive randomization
-
Shao J, Yu X, Zhong B. A theory for testing hypotheses under covariate-adaptive randomization. Biometrika 2010; 29(2):347-360.
-
(2010)
Biometrika
, vol.29
, Issue.2
, pp. 347-360
-
-
Shao, J.1
Yu, X.2
Zhong, B.3
-
11
-
-
0024583836
-
Covariate imbalance and random allocation in clinical trials
-
Senn SJ. Covariate imbalance and random allocation in clinical trials. Statistics in Medicine 1989; 8:467-475.
-
(1989)
Statistics in Medicine
, vol.8
, pp. 467-475
-
-
Senn, S.J.1
-
12
-
-
84886993170
-
Covariate imbalance and adjustment for logistic regression analysis of clinical trial data
-
Ciolino JD, Martin RH, Zhao W, Jauch EC, Hill MD, Palesch YY. Covariate imbalance and adjustment for logistic regression analysis of clinical trial data. Biopharmaceutical Statistics 2013; 23(6):1383-1402.
-
(2013)
Biopharmaceutical Statistics
, vol.23
, Issue.6
, pp. 1383-1402
-
-
Ciolino, J.D.1
Martin, R.H.2
Zhao, W.3
Jauch, E.C.4
Hill, M.D.5
Palesch, Y.Y.6
-
13
-
-
77956891487
-
Biased estimates of treatment effect in randomized experiments with nonlinear regressions and omitted covariates
-
Gail MH, Wieand S, Piantadosi S. Biased estimates of treatment effect in randomized experiments with nonlinear regressions and omitted covariates. Biometrika 1984; 71(3):431-444.
-
(1984)
Biometrika
, vol.71
, Issue.3
, pp. 431-444
-
-
Gail, M.H.1
Wieand, S.2
Piantadosi, S.3
-
14
-
-
0002545717
-
Tests for no treatment effect in randomized clinical trials
-
Gail MH, Tan WY, Piantadosi S. Tests for no treatment effect in randomized clinical trials. Biometrika 1988; 75(1):57-64.
-
(1988)
Biometrika
, vol.75
, Issue.1
, pp. 57-64
-
-
Gail, M.H.1
Tan, W.Y.2
Piantadosi, S.3
-
15
-
-
0000029731
-
Some surprising results about covariate adjustment in logistic regression models
-
Robinson LD, Jewell NP. Some surprising results about covariate adjustment in logistic regression models. International Statistical Review 1991; 59(2):227-240.
-
(1991)
International Statistical Review
, vol.59
, Issue.2
, pp. 227-240
-
-
Robinson, L.D.1
Jewell, N.P.2
-
16
-
-
0000785485
-
A geometric approach to assess bias due to omitted covariates in generalized linear models
-
Neuhaus JM, Jewell NP. A geometric approach to assess bias due to omitted covariates in generalized linear models. Biometrika 1993; 80(4):807-815.
-
(1993)
Biometrika
, vol.80
, Issue.4
, pp. 807-815
-
-
Neuhaus, J.M.1
Jewell, N.P.2
-
17
-
-
0029005426
-
Model inconcsistency, illustrated by the cox proportional hazards model
-
Ford I, Norrie J, Ahmadi S. Model inconcsistency, illustrated by the cox proportional hazards model. Statistics in Medicine 1995; 14:735-746.
-
(1995)
Statistics in Medicine
, vol.14
, pp. 735-746
-
-
Ford, I.1
Norrie, J.2
Ahmadi, S.3
-
18
-
-
0024791598
-
Choosing covariates in the analysis of clinical trials
-
Beach ML, Meier P. Choosing covariates in the analysis of clinical trials. Controlled Clinical Trials 1989; 10:161S-175S.
-
(1989)
Controlled Clinical Trials
, vol.10
, pp. 161S-175S
-
-
Beach, M.L.1
Meier, P.2
-
19
-
-
0028101076
-
Testing for baseline balance in clinical trials
-
Senn SJ. Testing for baseline balance in clinical trials. Statistics in Medicine 1994; 13:715-1726.
-
(1994)
Statistics in Medicine
, vol.13
, pp. 715-1726
-
-
Senn, S.J.1
-
20
-
-
77950868646
-
Noninferiority tial designs for odds ratios and risk differences
-
Hilton JF. Noninferiority tial designs for odds ratios and risk differences. Statistics in Medicine 2010; 29:982-993.
-
(2010)
Statistics in Medicine
, vol.29
, pp. 982-993
-
-
Hilton, J.F.1
-
21
-
-
14544302160
-
Conditional and marginal models: another view
-
Lee Y, Nelder JA. Conditional and marginal models: another view. Statistics Science 2004; 19:219-228.
-
(2004)
Statistics Science
, vol.19
, pp. 219-228
-
-
Lee, Y.1
Nelder, J.A.2
-
22
-
-
78650251050
-
Conditional and marginal models: another view - comments and rejoinders
-
Senn SJ. Conditional and marginal models: another view - comments and rejoinders. Statistics Science 2004; 19:228-238.
-
(2004)
Statistics Science
, vol.19
, pp. 228-238
-
-
Senn, S.J.1
-
23
-
-
84856510062
-
Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness
-
Zhao W, Weng Y, Wu Q, Palesch Y. Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness. Pharmaceutical Statistics 2012; 11(1):39-48.
-
(2012)
Pharmaceutical Statistics
, vol.11
, Issue.1
, pp. 39-48
-
-
Zhao, W.1
Weng, Y.2
Wu, Q.3
Palesch, Y.4
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