-
1
-
-
0031003468
-
Learning versus confirming in clinical drug development
-
DOI 10.1016/S0009-9236(97)90160-0
-
Sheiner LB. Learning versus confirming in clinical drug development. Clinical Pharmacology and Therapeutics. 1997 ; 61: 275-91 (Pubitemid 27145429)
-
(1997)
Clinical Pharmacology and Therapeutics
, vol.61
, Issue.3
, pp. 275-291
-
-
Sheiner, L.B.1
-
2
-
-
33748521268
-
Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: General concepts
-
DOI 10.1002/bimj.200510232
-
Bretz F, Schmidli S, König F, Racine A, Maurer W. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts. Biometrical Journal. 2006 ; 48: 623-34 (Pubitemid 44367905)
-
(2006)
Biometrical Journal
, vol.48
, Issue.4
, pp. 623-634
-
-
Bretz, F.1
Schmidli, H.2
Konig, F.3
Racine, A.4
Maurer, W.5
-
3
-
-
33748533820
-
Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: Applications and practical considerations
-
DOI 10.1002/bimj.200510231
-
Schmidli H, Bretx F, Racine A, Maurer W. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations. Biometrical Journal. 2006 ; 48: 635-43 (Pubitemid 44367906)
-
(2006)
Biometrical Journal
, vol.48
, Issue.4
, pp. 635-643
-
-
Schmidli, H.1
Bretz, F.2
Racine, A.3
Maurer, W.4
-
4
-
-
33646245937
-
Adaptive designs in clinical drug development: An executive summary of the PhRMA Working Group
-
Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J. Adaptive designs in clinical drug development: an executive summary of the PhRMA Working Group. Journal of Biopharmaceutical Statistics. 2006 ; 16: 275-83
-
(2006)
Journal of Biopharmaceutical Statistics
, vol.16
, pp. 275-83
-
-
Gallo, P.1
Chuang-Stein, C.2
Dragalin, V.3
Gaydos, B.4
Krams, M.5
Pinheiro, J.6
-
5
-
-
33750854113
-
Adaptive seamless phase II/III designs - Background, operational aspects, and examples
-
Maca J, Bhattacharya S, Dragalin V, Gallo P, Krams M. Adaptive seamless Phase II/III designs: background, operational aspects, and examples. Drug Information Journal. 2006 ; 40: 463-73 (Pubitemid 44721124)
-
(2006)
Drug Information Journal
, vol.40
, Issue.4
, pp. 463-473
-
-
Maca, J.1
Bhattacharya, S.2
Dragalin, V.3
Gallo, P.4
Krams, M.5
-
6
-
-
0037445466
-
Sequential designs for phase III clinical trials incorporating treatment selection
-
DOI 10.1002/sim.1362
-
Stallard N, Todd S. Sequential designs for phase III clinical trials incorporating treatment selection. Statistics in Medicine. 2003 ; 22: 689-703 (Pubitemid 36266961)
-
(2003)
Statistics in Medicine
, vol.22
, Issue.5
, pp. 689-703
-
-
Stallard, N.1
Todd, S.2
-
7
-
-
0033618626
-
Combining different phases in the development of medical treatments within a single trial
-
DOI 10.1002/(SICI)1097-0258(19990730)18:14<1833::AID-SIM221>3.0. CO;2-3
-
Bauer P, Kieser M. Combining different phases in the development of medical treatments within a single trial. Statistics in Medicine. 1999 ; 18: 1833-48 (Pubitemid 29364054)
-
(1999)
Statistics in Medicine
, vol.18
, Issue.14
, pp. 1833-1848
-
-
Bauer, P.1
Kieser, M.2
-
8
-
-
42449156446
-
Adaptive Dunnett tests for treatment selection
-
DOI 10.1002/sim.3048
-
Koenig F, Brannath W, Bretz F, Posch M. Adaptive Dunnett tests for treatment selection. Statistics in Medicine. 2008 ; 27: 1612-25 (Pubitemid 351566086)
-
(2008)
Statistics in Medicine
, vol.27
, Issue.10
, pp. 1612-1625
-
-
Koenig, F.1
Brannath, W.2
Bretz, F.3
Posch, M.4
-
11
-
-
0017146303
-
On closed testing procedures with special reference to ordered analysis of variance
-
Marcus R, Peritz E, Gabriel KR. On closed testing procedures with special reference to ordered analysis of variance. Biometrika. 1976 ; 63: 655-60
-
(1976)
Biometrika
, vol.63
, pp. 655-60
-
-
Marcus, R.1
Peritz, E.2
Gabriel, K.R.3
-
12
-
-
0009663357
-
A multiple comparison procedure for comparing several treatments with a control
-
Dunnett CW. A multiple comparison procedure for comparing several treatments with a control. Journal of the American Statistical Association. 1955 ; 50: 1096-121
-
(1955)
Journal of the American Statistical Association
, vol.50
, pp. 1096-121
-
-
Dunnett, C.W.1
-
13
-
-
22044437664
-
A practical comparison of group-sequential and adaptive designs
-
DOI 10.1081/BIP-200062859
-
Kelly PJ, Sooriyarachchi MR, Stallard N, Todd S. A practical comparison of group-sequential and adaptive designs. Journal of Biopharmaceutical Statistics. 2005 ; 15: 719-38 (Pubitemid 40967311)
-
(2005)
Journal of Biopharmaceutical Statistics
, vol.15
, Issue.4
, pp. 719-738
-
-
Kelly, P.J.1
Sooriyarachchi, M.R.2
Stallard, N.3
Todd, S.4
-
14
-
-
0034876356
-
Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches
-
Müller H-H, Schäfer H. Adaptive group sequential designs for clinical trials: combining the advantages of the adaptive and of classical group sequential approaches. Biometrics. 2001 ; 57: 886-91 (Pubitemid 32801186)
-
(2001)
Biometrics
, vol.57
, Issue.3
, pp. 886-891
-
-
Muller, H.-H.1
Schafer, H.2
-
17
-
-
70449529019
-
Discrete sequential boundaries for clinical trials
-
Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika. 1983 ; 70: 659-63
-
(1983)
Biometrika
, vol.70
, pp. 659-63
-
-
Kkg, L.1
Demets, D.L.2
-
18
-
-
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: 149-54
-
(1987)
Biometrika
, vol.74
, pp. 149-54
-
-
Kim, K.1
Demets, D.L.2
-
19
-
-
0029781192
-
Comparison of the spending function method and the Christmas tree correction for group sequential trials
-
Stallard N, Facey KM. Comparison of the spending function method and the Christmas tree correction for group sequential trials. Journal of Biopharmaceutical Statistics. 1990 ; 6: 361-73
-
(1990)
Journal of Biopharmaceutical Statistics
, vol.6
, pp. 361-73
-
-
Stallard, N.1
Facey, K.M.2
-
22
-
-
32644466402
-
Evaluation of experiments with adaptive interim analyses
-
Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics. 1994 ; 51: 1315-24
-
(1994)
Biometrics
, vol.51
, pp. 1315-24
-
-
Bauer, P.1
Köhne, K.2
-
23
-
-
0032732411
-
Adaptive sample size calculations in group sequential tests
-
Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential tests. Biometrics. 1999 ; 55: 1286-90
-
(1999)
Biometrics
, vol.55
, pp. 1286-90
-
-
Lehmacher, W.1
Wassmer, G.2
-
25
-
-
4344665155
-
A general statistical principle for changing a design any time during the course of a trial
-
DOI 10.1002/sim.1852
-
Müller H-H, Schäfer H. A general statistical principle for changing a design any time during the course of a trial. Statistics in Medicine. 2004 ; 23: 2497-508 (Pubitemid 39149263)
-
(2004)
Statistics in Medicine
, vol.23
, Issue.16
, pp. 2497-2508
-
-
Muller, H.-H.1
Schafer, H.2
-
26
-
-
0024381579
-
A two-stage design for choosing among several experimental treatments and a control in clinical trials
-
Thall PF, Simon R, Ellenberg SS. A two-stage design for choosing among several experimental treatments and a control in clinical trials. Biometrics. 1988 ; 45: 537-47 (Pubitemid 19165264)
-
(1989)
Biometrics
, vol.45
, Issue.2
, pp. 537-547
-
-
Thall, P.F.1
Simon, R.2
Ellenberg, S.S.3
-
27
-
-
0000466114
-
Two-stage selection and testing designs for comparative clinical trials
-
Thall PF, Simon R, Ellenberg SS. Two-stage selection and testing designs for comparative clinical trials. Biometrika. 1989 ; 75: 303-10
-
(1989)
Biometrika
, vol.75
, pp. 303-10
-
-
Thall, P.F.1
Simon, R.2
Ellenberg, S.S.3
-
28
-
-
0000623392
-
Optimal two-stage screening designs for survival comparisons
-
Schaid DJ, Wieand S, Therneau TM. Optimal two-stage screening designs for survival comparisons. Biometrika. 1990 ; 77: 507-13
-
(1990)
Biometrika
, vol.77
, pp. 507-13
-
-
Schaid, D.J.1
Wieand, S.2
Therneau, T.M.3
-
29
-
-
33748528963
-
Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: Opportunities and limitations
-
DOI 10.1002/bimj.200610248
-
Jennison C, Turnbull BW. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: opportunities and limitations. Biometrical Journal. 2006 ; 48: 650-55 (Pubitemid 44367908)
-
(2006)
Biometrical Journal
, vol.48
, Issue.4
, pp. 650-655
-
-
Jennison, C.1
Turnbull, B.W.2
-
30
-
-
54549113164
-
Flexible group-sequential designs for clinical trials with treatment selection
-
Stallard N, Friede T. Flexible group-sequential designs for clinical trials with treatment selection. Statistics in Medicine. 2008 ; 27: 6209-27
-
(2008)
Statistics in Medicine
, vol.27
, pp. 6209-27
-
-
Stallard, N.1
Friede, T.2
-
31
-
-
30944469129
-
Testing and estimation in flexible group sequential designs with adaptive treatment selection
-
DOI 10.1002/sim.2389
-
Posch M, Koenig F, Branson M, Brannath W, Dunger-Baldauf C, Bauer P. Testing and estimation in flexible group sequential designs with adaptive treatment selection. Statistics in Medicine. 2005 ; 24: 3697-714 (Pubitemid 43115726)
-
(2005)
Statistics in Medicine
, vol.24
, Issue.24
, pp. 3697-3714
-
-
Posch, M.1
Koenig, F.2
Branson, M.3
Brannath, W.4
Dunger-Baldauf, C.5
Bauer, P.6
-
32
-
-
0021323563
-
Repeated confidence intervals for group sequential clinical trials
-
DOI 10.1016/0197-2456(84)90148-X
-
Jennison C, Turnbull BW. Repeated confidence intervals for group sequential trials. Controlled Clinical Trials. 1984 ; 5: 33-45 (Pubitemid 14149644)
-
(1984)
Controlled Clinical Trials
, vol.5
, Issue.1
, pp. 33-45
-
-
Jennison, C.1
Turnbull, B.W.2
-
34
-
-
18444411392
-
A new clinical trial design combining phases 2 and 3: Sequential designs with treatment selection and a change of endpoint
-
Todd S, Stallard N. A new clinical trial design combining phases II and III: Sequential designs with treatment selection and a change of endpoint. Drug Information Journal. 2005 ; 39: 109-18 (Pubitemid 40647117)
-
(2005)
Drug Information Journal
, vol.39
, Issue.2
, pp. 109-118
-
-
Todd, S.1
Stallard, N.2
-
35
-
-
54549109142
-
A comparison of methods for adaptive treatment selection
-
Friede T, Stallard N. A comparison of methods for adaptive treatment selection. Biometrical Journal. 2008 ; 50: 767-81
-
(2008)
Biometrical Journal
, vol.50
, pp. 767-81
-
-
Friede, T.1
Stallard, N.2
-
36
-
-
33646260128
-
Are flexible designs sound?
-
Burman C-F, Sonesson C. Are flexible designs sound?. Biometrics. 2006 ; 62: 664-9
-
(2006)
Biometrics
, vol.62
, pp. 664-9
-
-
Burman, C.-F.1
Sonesson, C.2
-
37
-
-
1942520346
-
Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections (multiple letters)
-
DOI 10.1002/sim.1759
-
Bauer P, Posch M. Letter to the editor: modification of the sample size and the schedule of interim analyses in survival trials based on data inspections. Statistics in Medicine. 2004 ; 23: 1333-35 (Pubitemid 38514827)
-
(2004)
Statistics in Medicine
, vol.23
, Issue.8
, pp. 1333-1335
-
-
Schafer, H.1
Muller, H.-H.2
Bauer, P.3
Posch, M.4
-
38
-
-
77950912779
-
A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information
-
Stallard N. A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information. Statistics in Medicine. 2010 ; 29: 959-971
-
(2010)
Statistics in Medicine
, vol.29
, pp. 959-971
-
-
Stallard, N.1
-
41
-
-
0035879557
-
An improved method of evaluating drug effect in a multiple dose clinical trial
-
DOI 10.1002/sim.842
-
Shen L. An improved method of evaluating drug effect in a multiple dose clinical trial. Statistics in Medicine. 2001 ; 20: 1913-29 (Pubitemid 32605721)
-
(2001)
Statistics in Medicine
, vol.20
, Issue.13
, pp. 1913-1929
-
-
Shen, L.1
-
42
-
-
18444383925
-
Point estimates and confidence regions for sequential trials involving selection
-
DOI 10.1016/j.jspi.2004.05.006, PII S0378375804002344
-
Stallard N, Todd S. Point estimates and confidence regions for sequential trials involving selection. Journal of Statistical Planning and Inference. 2005 ; 135: 402-19 (Pubitemid 41235780)
-
(2005)
Journal of Statistical Planning and Inference
, vol.135
, Issue.2
, pp. 402-419
-
-
Stallard, N.1
Todd, S.2
|