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Items: 1 to 20 of 43


Adaptive Estimation of Personalized Maximum Tolerated Dose in Cancer Phase I Clinical Trials Based on All Toxicities and Individual Genomic Profile.

Chen Z, Li Z, Zhuang R, Yuan Y, Kutner M, Owonikoko T, Curran WJ, Kowalski J.

PLoS One. 2017 Jan 26;12(1):e0170187. doi: 10.1371/journal.pone.0170187. eCollection 2017.


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

Antoniou M, Kolamunnage-Dona R, Jorgensen AL.

J Pers Med. 2017 Jan 25;7(1). pii: E1. doi: 10.3390/jpm7010001. Review.


An adaptive design for updating the threshold value of a continuous biomarker.

Spencer AV, Harbron C, Mander A, Wason J, Peers I.

Stat Med. 2016 Nov 30;35(27):4909-4923. doi: 10.1002/sim.7042. Epub 2016 Jul 14.


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.


Clinical trial designs incorporating predictive biomarkers.

Renfro LA, Mallick H, An MW, Sargent DJ, Mandrekar SJ.

Cancer Treat Rev. 2016 Feb;43:74-82. doi: 10.1016/j.ctrv.2015.12.008. Epub 2016 Jan 5. Review.


A predictive enrichment procedure to identify potential responders to a new therapy for randomized, comparative controlled clinical studies.

Li J, Zhao L, Tian L, Cai T, Claggett B, Callegaro A, Dizier B, Spiessens B, Ulloa-Montoya F, Wei LJ.

Biometrics. 2016 Sep;72(3):877-87. doi: 10.1111/biom.12461. Epub 2015 Dec 21.


Subgroup identification for treatment selection in biomarker adaptive design.

Lu TP, Chen JJ.

BMC Med Res Methodol. 2015 Dec 9;15:105. doi: 10.1186/s12874-015-0098-7.


Clinical Neuropathology practice guide 5-2015: MGMT methylation pyrosequencing in glioblastoma: unresolved issues and open questions.

Bienkowski M, Berghoff AS, Marosi C, Wöhrer A, Heinzl H, Hainfellner JA, Preusser M.

Clin Neuropathol. 2015 Sep-Oct;34(5):250-7. Review.


Clinical Translation and Validation of a Predictive Biomarker for Patritumab, an Anti-human Epidermal Growth Factor Receptor 3 (HER3) Monoclonal Antibody, in Patients With Advanced Non-small Cell Lung Cancer.

Mendell J, Freeman DJ, Feng W, Hettmann T, Schneider M, Blum S, Ruhe J, Bange J, Nakamaru K, Chen S, Tsuchihashi Z, von Pawel J, Copigneaux C, Beckman RA.

EBioMedicine. 2015 Feb 12;2(3):264-71. doi: 10.1016/j.ebiom.2015.02.005. eCollection 2015 Mar.


Designing a study to evaluate the benefit of a biomarker for selecting patient treatment.

Janes H, Brown MD, Pepe MS.

Stat Med. 2015 Nov 30;34(27):3503-15. doi: 10.1002/sim.6564. Epub 2015 Jun 25.


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.


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.


Choosing inclusion criteria that minimize the time and cost of clinical trials.

Babbs CF.

World J Methodol. 2014 Jun 26;4(2):109-22. doi: 10.5662/wjm.v4.i2.109. eCollection 2014 Jun 26.


Influence of secreted frizzled receptor protein 1 (SFRP1) on neoadjuvant chemotherapy in triple negative breast cancer does not rely on WNT signaling.

Bernemann C, Hülsewig C, Ruckert C, Schäfer S, Blümel L, Hempel G, Götte M, Greve B, Barth PJ, Kiesel L, Liedtke C.

Mol Cancer. 2014 Jul 17;13:174. doi: 10.1186/1476-4598-13-174.


Analyzing longitudinal data to characterize the accuracy of markers used to select treatment.

Sitlani CM, Heagerty PJ.

Stat Med. 2014 Jul 30;33(17):2881-96. doi: 10.1002/sim.6138. Epub 2014 Mar 13.


Drug-diagnostics co-development in oncology.

Simon R.

Front Oncol. 2013 Dec 23;3:315. doi: 10.3389/fonc.2013.00315. Review.


Statistical and practical considerations for clinical evaluation of predictive biomarkers.

Polley MY, Freidlin B, Korn EL, Conley BA, Abrams JS, McShane LM.

J Natl Cancer Inst. 2013 Nov 20;105(22):1677-83. doi: 10.1093/jnci/djt282. Epub 2013 Oct 17.


Run-in phase III trial design with pharmacodynamics predictive biomarkers.

Hong F, Simon R.

J Natl Cancer Inst. 2013 Nov 6;105(21):1628-33. doi: 10.1093/jnci/djt265. Epub 2013 Oct 4.

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