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Items: 1 to 20 of 57

1.

Biomarkers, subgroup evaluation, and clinical trial design.

Baker SG, Kramer BS, Sargent DJ, Bonetti M.

Discov Med. 2012 Mar;13(70):187-92. Review.

PMID:
22463794
2.

Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect.

Jiang W, Freidlin B, Simon R.

J Natl Cancer Inst. 2007 Jul 4;99(13):1036-43. Epub 2007 Jun 27.

PMID:
17596577
3.

Prostate cancer chemoprevention: Strategies for designing efficient clinical trials.

Lieberman R.

Urology. 2001 Apr;57(4 Suppl 1):224-9.

PMID:
11295633
4.

Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives.

Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G.

Health Technol Assess. 2001;5(33):1-56. Review.

PMID:
11701102
5.

Adaptive designs for subpopulation analysis optimizing utility functions.

Graf AC, Posch M, Koenig F.

Biom J. 2015 Jan;57(1):76-89. doi: 10.1002/bimj.201300257. Epub 2014 Nov 14.

PMID:
25399844
8.

Evaluating surrogate markers.

Hughes MD, DeGruttola V, Welles SL.

J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S1-8. Review.

PMID:
7552506
9.

Adaptive methods: telling "the rest of the story".

Emerson SS, Fleming TR.

J Biopharm Stat. 2010 Nov;20(6):1150-65. doi: 10.1080/10543406.2010.514457.

PMID:
21058111
10.

Issues in subgroup analyses and meta-analyses of clinical trials.

Bigger JT.

J Cardiovasc Electrophysiol. 2003 Sep;14(9 Suppl):S6-8.

PMID:
12950510
11.

Marker Sequential Test (MaST) design.

Freidlin B, Korn EL, Gray R.

Clin Trials. 2014 Feb;11(1):19-27. doi: 10.1177/1740774513503739. Epub 2013 Oct 1.

PMID:
24085774
12.

Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

De Gruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, Friedman L, Gail MH, Prentice R, Wittes J, Zeger SL.

Control Clin Trials. 2001 Oct;22(5):485-502.

PMID:
11578783
13.

Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset.

Wang SJ, O'Neill RT, Hung HM.

Pharm Stat. 2007 Jul-Sep;6(3):227-44.

PMID:
17688238
14.

Clinical trial simulation to assist in COPD trial planning and design with a biomarker-based diagnostic: when to pull the trigger?

Gold DL, Dawson M, Yang H, Parker J, Gossage DL.

COPD. 2014 Apr;11(2):226-35. doi: 10.3109/15412555.2013.836170. Epub 2013 Oct 10.

PMID:
24111823
15.

The cross-validated adaptive signature design.

Freidlin B, Jiang W, Simon R.

Clin Cancer Res. 2010 Jan 15;16(2):691-8. doi: 10.1158/1078-0432.CCR-09-1357. Epub 2010 Jan 12.

PMID:
20068112
16.

Regulatory perspectives on multiplicity in adaptive design clinical trials throughout a drug development program.

Wang SJ, Hung HM, O'Neill R.

J Biopharm Stat. 2011 Jul;21(4):846-59. doi: 10.1080/10543406.2011.552878.

PMID:
21516573
17.

Repaglinide : a pharmacoeconomic review of its use in type 2 diabetes mellitus.

Plosker GL, Figgitt DP.

Pharmacoeconomics. 2004;22(6):389-411. Review.

PMID:
15099124
18.

A two-stage Bayesian design for co-development of new drugs and companion diagnostics.

Karuri SW, Simon R.

Stat Med. 2012 May 10;31(10):901-14. doi: 10.1002/sim.4462. Epub 2012 Jan 11.

PMID:
22238151
19.

Rationale for a non-inferiority clinical trial design focused on subpopulations.

Kulkarni PM, Meadows ES, Ahuja S, Muram D, Plouffe L Jr.

Curr Med Res Opin. 2004 Oct;20(10):1641-7.

PMID:
15462697
20.

Omics-based clinical trial designs.

Buyse M, Michiels S.

Curr Opin Oncol. 2013 May;25(3):289-95. doi: 10.1097/CCO.0b013e32835ff2fe. Review.

PMID:
23475192

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