-
1
-
-
0031003468
-
Learning versus confirming in clinical drug development
-
Sheiner LB.Learning versus confirming in clinical drug development.Clin Pharmacol Ther. 1997;61 (3): 275-291
-
(1997)
Clin Pharmacol Ther
, vol.61
, Issue.3
, pp. 275-291
-
-
Sheiner, L.B.1
-
2
-
-
77149134951
-
Proof of concept: a PhRMA position paper with recommendations for best practice
-
,,, et al.. ; (): -
-
Cartwright ME,Cohen S,Fleishaker JC, et al.Proof of concept: a PhRMA position paper with recommendations for best practice.Clin Pharmacol Ther. 2010;87 (3): 278-285
-
(2010)
Clin Pharmacol Ther
, vol.87
, Issue.3
, pp. 278-285
-
-
Cartwright, M.E.1
Cohen, S.2
Fleishaker, J.C.3
-
3
-
-
77149155968
-
Trends in risks associated with new drug development: success rates for investigational drugs
-
DiMasi JA,Feldman L,Seckler A,Wilson A.Trends in risks associated with new drug development: success rates for investigational drugs.Clin Pharmacol Ther. 2010;87 (3): 272-277
-
(2010)
Clin Pharmacol Ther
, vol.87
, Issue.3
, pp. 272-277
-
-
DiMasi, J.A.1
Feldman, L.2
Seckler, A.3
Wilson, A.4
-
4
-
-
84859203764
-
A portfolio-based approach to optimize proof-of-concept clinical trials
-
Mallinckrodt C,Molenberghs G,Persinger C,Ruberg S,Sashegyi A,Lindborg S.A portfolio-based approach to optimize proof-of-concept clinical trials.J Biopharm Stat. 2012;22 (3): 596-607
-
(2012)
J Biopharm Stat
, vol.22
, Issue.3
, pp. 596-607
-
-
Mallinckrodt, C.1
Molenberghs, G.2
Persinger, C.3
Ruberg, S.4
Sashegyi, A.5
Lindborg, S.6
-
5
-
-
79956150537
-
A proof of concept phase II non-inferiority criterion
-
Neuenschwander B,Rouyrre N,Hollaender N,Zuber E,Branson M.A proof of concept phase II non-inferiority criterion.Stat Med. 2011;30 (13): 1618-1627
-
(2011)
Stat Med
, vol.30
, Issue.13
, pp. 1618-1627
-
-
Neuenschwander, B.1
Rouyrre, N.2
Hollaender, N.3
Zuber, E.4
Branson, M.5
-
6
-
-
79956156443
-
The role of the minimum clinically important difference and its impact on designing a trial
-
Chuang-Stein C,Kirby S,Hirsch I,Atkinson G.The role of the minimum clinically important difference and its impact on designing a trial.Biopharm Stat. 2011;10 (3): 250-256
-
(2011)
Biopharm Stat
, vol.10
, Issue.3
, pp. 250-256
-
-
Chuang-Stein, C.1
Kirby, S.2
Hirsch, I.3
Atkinson, G.4
-
7
-
-
79955708726
-
A quantitative approach for making go/no-go decisions in drug development
-
,,, et al.. ;:-
-
Chuang-Stein C,Kirby S,French J, et al.A quantitative approach for making go/no-go decisions in drug development.Drug Inf J. 2011;45:187-202
-
(2011)
Drug Inf J
, vol.45
, pp. 187-202
-
-
Chuang-Stein, C.1
Kirby, S.2
French, J.3
-
8
-
-
0027257217
-
Applying Bayesian ideas in drug development and clinical trials
-
Spiegelhalter DJ,Freedman LS,Parmar MKB.Applying Bayesian ideas in drug development and clinical trials.Stat Med. 1993;12 ((15-16)): 1501-1511
-
(1993)
Stat Med
, vol.12
, Issue.15-16
, pp. 1501-1511
-
-
Spiegelhalter, D.J.1
Freedman, L.S.2
Parmar, M.K.B.3
-
9
-
-
0012863523
-
-
,,. New York, NY: ; :, John Wiley & Sons
-
Spiegelhalter DJ,Abrams KR,Myles JPBayesian Approaches to Clinical Trials and Health Care Evaluation. New York, NY: John Wiley & Sons; 2004:
-
(2004)
Bayesian Approaches to Clinical Trials and Health Care Evaluation
-
-
Spiegelhalter, D.J.1
Abrams, K.R.2
Myles, J.P.3
-
10
-
-
37549015646
-
Practical Bayesian design and analysis for drug and device clinical trials
-
Hobbs BP,Carlin BP.Practical Bayesian design and analysis for drug and device clinical trials.J Biopharm Stat. 2007;18:54-80
-
(2007)
J Biopharm Stat
, vol.18
, pp. 54-80
-
-
Hobbs, B.P.1
Carlin, B.P.2
-
11
-
-
85122716876
-
-
,,,. London, UK: ; :, Chapman & Hall/CRC
-
Berry SM,Carlin BP,Lee JJ,Müller PBayesian Adaptive Methods for Clinical Trials. London, UK: Chapman & Hall/CRC; 2010:
-
(2010)
Bayesian Adaptive Methods for Clinical Trials
-
-
Berry, S.M.1
Carlin, B.P.2
Lee, J.J.3
Müller, P.4
-
12
-
-
84950453304
-
Sampling-based approaches to calculating marginal densities
-
Gelfand AE,Smith AFM.Sampling-based approaches to calculating marginal densities.J Am Stat Assoc. 1990;85:398-409
-
(1990)
J Am Stat Assoc
, vol.85
, pp. 398-409
-
-
Gelfand, A.E.1
Smith, A.F.M.2
-
13
-
-
77749255548
-
Summarizing historical information on controls in clinical trials
-
Neuenschwander B,Capkun-Niggli G,Branson M,Spiegelhalter DJ.Summarizing historical information on controls in clinical trials.Clin Trials. 2010;7 (1): 5-18
-
(2010)
Clin Trials
, vol.7
, Issue.1
, pp. 5-18
-
-
Neuenschwander, B.1
Capkun-Niggli, G.2
Branson, M.3
Spiegelhalter, D.J.4
-
14
-
-
84883134848
-
Using historical control information for the design and analysis of clinical trials with overdispersed count data
-
Gsteiger S,Neuenschwander B,Mercier F,Schmidli H.Using historical control information for the design and analysis of clinical trials with overdispersed count data.Stat Med. 2013;32 (21): 3609-3622
-
(2013)
Stat Med
, vol.32
, Issue.21
, pp. 3609-3622
-
-
Gsteiger, S.1
Neuenschwander, B.2
Mercier, F.3
Schmidli, H.4
-
15
-
-
70350343375
-
Efficacy of systemic treatments for moderate to severe plaque psoriasis: systematic review and meta-analysis
-
Bansback N,Sizto S,Sun H,Feldman S,Willian MK,Anis A.Efficacy of systemic treatments for moderate to severe plaque psoriasis: systematic review and meta-analysis.Dermatology. 2009;219 (3): 209-218
-
(2009)
Dermatology
, vol.219
, Issue.3
, pp. 209-218
-
-
Bansback, N.1
Sizto, S.2
Sun, H.3
Feldman, S.4
Willian, M.K.5
Anis, A.6
-
16
-
-
21244433490
-
Assessment of clinical relevance by considering point estimates and associated confidence intervals
-
Kieser M,Hauschke D.Assessment of clinical relevance by considering point estimates and associated confidence intervals.Biopharm Stat. 2005;4 (2): 101-107
-
(2005)
Biopharm Stat
, vol.4
, Issue.2
, pp. 101-107
-
-
Kieser, M.1
Hauschke, D.2
-
17
-
-
33644897345
-
Implementation of a Bayesian adaptive design in a proof of concept study
-
Smith MK,Jones I,Morris MF,Grieve AP,Tan K.Implementation of a Bayesian adaptive design in a proof of concept study.Biopharm Stat. 2006;5:39-50
-
(2006)
Biopharm Stat
, vol.5
, pp. 39-50
-
-
Smith, M.K.1
Jones, I.2
Morris, M.F.3
Grieve, A.P.4
Tan, K.5
-
18
-
-
84908216560
-
A practical guide to Bayesian group sequential designs
-
Gsponer T,Gerber F,Bornkamp B,Ohlssen D,Vandemeulebroecke M,Schmidli H.A practical guide to Bayesian group sequential designs.Biopharm Stat. 2014;13 (1): 71-80
-
(2014)
Biopharm Stat
, vol.13
, Issue.1
, pp. 71-80
-
-
Gsponer, T.1
Gerber, F.2
Bornkamp, B.3
Ohlssen, D.4
Vandemeulebroecke, M.5
Schmidli, H.6
-
19
-
-
84920971035
-
gsbDesign: an R Package for evaluating operating characteristics for a group sequential Bayesian design. submitted to
-
Gerber F,Gsponer T.gsbDesign: an R Package for evaluating operating characteristics for a group sequential Bayesian design. submitted to.J Stat Softw. 2014;:
-
(2014)
J Stat Softw
-
-
Gerber, F.1
Gsponer, T.2
-
20
-
-
33745610881
-
Bayesian predictive approach to interim monitoring in clinical trials
-
Dmitrienko A,Wang M-D.Bayesian predictive approach to interim monitoring in clinical trials.Stat Med. 2006;25:2178-2195
-
(2006)
Stat Med
, vol.25
, pp. 2178-2195
-
-
Dmitrienko, A.1
Wang, M.-D.2
-
21
-
-
84887992906
-
Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial
-
,,, et al.. ; (): -
-
Baeten D,Baraliakos X,Braun J, et al.Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial.Lancet. 2013;382 (9906): 1705-1713
-
(2013)
Lancet
, vol.382
, Issue.9906
, pp. 1705-1713
-
-
Baeten, D.1
Baraliakos, X.2
Braun, J.3
-
22
-
-
84868680312
-
Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn’s disease: unexpected results of a randomised, double-blind placebo-controlled trial
-
,,, et al.. ; (): -
-
Hueber W,Sands BE,Lewitzky S, et al.Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn’s disease: unexpected results of a randomised, double-blind placebo-controlled trial.Gut. 2012;61 (12): 1693-700
-
(2012)
Gut
, vol.61
, Issue.12
, pp. 1693-1700
-
-
Hueber, W.1
Sands, B.E.2
Lewitzky, S.3
|