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Items: 1 to 20 of 143


A review of phase II trial designs for initial marker validation.

Mandrekar SJ, An MW, Sargent DJ.

Contemp Clin Trials. 2013 Nov;36(2):597-604. doi: 10.1016/j.cct.2013.05.001. Epub 2013 May 8. Review.


A 2-stage phase II design with direct assignment option in stage II for initial marker validation.

An MW, Mandrekar SJ, Sargent DJ.

Clin Cancer Res. 2012 Aug 15;18(16):4225-33. doi: 10.1158/1078-0432.CCR-12-0686. Epub 2012 Jun 14.


All-comers versus enrichment design strategy in phase II trials.

Mandrekar SJ, Sargent DJ.

J Thorac Oncol. 2011 Apr;6(4):658-60. doi: 10.1097/JTO.0b013e31820e17cb.


Predictive biomarker validation in practice: lessons from real trials.

Mandrekar SJ, Sargent DJ.

Clin Trials. 2010 Oct;7(5):567-73. doi: 10.1177/1740774510368574. Epub 2010 Apr 14.


Design issues of randomized phase II trials and a proposal for phase II screening trials.

Rubinstein LV, Korn EL, Freidlin B, Hunsberger S, Ivy SP, Smith MA.

J Clin Oncol. 2005 Oct 1;23(28):7199-206.


Comparison of error rates in single-arm versus randomized phase II cancer clinical trials.

Tang H, Foster NR, Grothey A, Ansell SM, Goldberg RM, Sargent DJ.

J Clin Oncol. 2010 Apr 10;28(11):1936-41. doi: 10.1200/JCO.2009.25.5489. Epub 2010 Mar 8.


Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment.

An MW, Mandrekar SJ, Edelman MJ, Sargent DJ.

Contemp Clin Trials. 2014 Jul;38(2):157-62. doi: 10.1016/j.cct.2014.04.007. Epub 2014 Apr 24.


Design of clinical trials for biomarker research in oncology.

Mandrekar SJ, Sargent DJ.

Clin Investig (Lond). 2011 Dec;1(12):1629-1636.


Optimal designs for two-arm, phase II clinical trial design with multiple constraints.

Mayo MS, Mahnken JD, Soong SJ.

J Biopharm Stat. 2010 Jan;20(1):106-24. doi: 10.1080/10543400903280597.


Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges.

Mandrekar SJ, Sargent DJ.

J Clin Oncol. 2009 Aug 20;27(24):4027-34. doi: 10.1200/JCO.2009.22.3701. Epub 2009 Jul 13.


Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

Antoniou M, Jorgensen AL, Kolamunnage-Dona R.

PLoS One. 2016 Feb 24;11(2):e0149803. doi: 10.1371/journal.pone.0149803. eCollection 2016. Review.


Randomized phase II trials: a long-term investment with promising returns.

Sharma MR, Stadler WM, Ratain MJ.

J Natl Cancer Inst. 2011 Jul 20;103(14):1093-100. doi: 10.1093/jnci/djr218. Epub 2011 Jun 27. Review.


Randomized phase II trial designs with biomarkers.

Freidlin B, McShane LM, Polley MY, Korn EL.

J Clin Oncol. 2012 Sep 10;30(26):3304-9. doi: 10.1200/JCO.2012.43.3946. Epub 2012 Aug 6.


The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee.

Seymour L, Ivy SP, Sargent D, Spriggs D, Baker L, Rubinstein L, Ratain MJ, Le Blanc M, Stewart D, Crowley J, Groshen S, Humphrey JS, West P, Berry D.

Clin Cancer Res. 2010 Mar 15;16(6):1764-9. doi: 10.1158/1078-0432.CCR-09-3287. Epub 2010 Mar 9.


The direct assignment option as a modular design component: an example for the setting of two predefined subgroups.

An MW, Lu X, Sargent DJ, Mandrekar SJ.

Comput Math Methods Med. 2015;2015:210817. doi: 10.1155/2015/210817. Epub 2015 Jan 15.


Adaptive randomized phase II design for biomarker threshold selection and independent evaluation.

Renfro LA, Coughlin CM, Grothey AM, Sargent DJ.

Chin Clin Oncol. 2014 Mar;3(1):3. doi: 10.3978/j.issn.2304-3865.2013.12.04.


Comparison of different clinical development plans for confirmatory subpopulation selection.

Rufibach K, Chen M, Nguyen H.

Contemp Clin Trials. 2016 Mar;47:78-84. doi: 10.1016/j.cct.2015.12.014. Epub 2015 Dec 29.


Adaptive randomized phase II design for biomarker threshold selection and independent evaluation.

Renfro LA, Coughlin CM, Grothey AM, Sargent DJ.

Chin Clin Oncol. 2014 Mar 1;3(1). pii: 3489.


The use of Bayesian hierarchical models for adaptive randomization in biomarker-driven phase II studies.

Barry WT, Perou CM, Marcom PK, Carey LA, Ibrahim JG.

J Biopharm Stat. 2015;25(1):66-88. doi: 10.1080/10543406.2014.919933.

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