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Items: 1 to 20 of 100

1.

Design of clinical trials for biomarker research in oncology.

Mandrekar SJ, Sargent DJ.

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

2.
3.

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.

4.

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.

5.

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.

6.

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.

7.

Predictive biomarkers in colorectal cancer: usage, validation, and design in clinical trials.

Shi Q, Mandrekar SJ, Sargent DJ.

Scand J Gastroenterol. 2012 Mar;47(3):356-62. doi: 10.3109/00365521.2012.640836. Epub 2011 Dec 19. Review.

PMID:
22181041
8.

Clinical trial designs for predictive biomarker validation: one size does not fit all.

Mandrekar SJ, Sargent DJ.

J Biopharm Stat. 2009;19(3):530-42. doi: 10.1080/10543400902802458.

9.

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.

10.

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.

11.

Reinventing clinical trials: a review of innovative biomarker trial designs in cancer therapies.

Lin JA, He P.

Br Med Bull. 2015 Jun;114(1):17-27. doi: 10.1093/bmb/ldv011. Epub 2015 Apr 28. Review.

PMID:
25921239
12.

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.

13.

Overview of the epidemiology methods and applications: strengths and limitations of observational study designs.

Colditz GA.

Crit Rev Food Sci Nutr. 2010;50 Suppl 1:10-2. doi: 10.1080/10408398.2010.526838.

14.
15.

The effectiveness of internet-based e-learning on clinician behavior and patient outcomes: a systematic review protocol.

Sinclair P, Kable A, Levett-Jones T.

JBI Database System Rev Implement Rep. 2015 Jan;13(1):52-64. doi: 10.11124/jbisrir-2015-1919.

PMID:
26447007
16.

Adaptive designs for clinical trials assessing biomarker-guided treatment strategies.

Wason J, Marshall A, Dunn J, Stein RC, Stallard N.

Br J Cancer. 2014 Apr 15;110(8):1950-7. doi: 10.1038/bjc.2014.156. Epub 2014 Mar 25.

17.

Group sequential designs for developing and testing biomarker-guided personalized therapies in comparative effectiveness research.

Lai TL, Liao OY, Kim DW.

Contemp Clin Trials. 2013 Nov;36(2):651-63. doi: 10.1016/j.cct.2013.08.007. Epub 2013 Aug 29.

PMID:
23994669
18.

Biomarker research with prospective study designs for the early detection of cancer.

Pesch B, Brüning T, Johnen G, Casjens S, Bonberg N, Taeger D, Müller A, Weber DG, Behrens T.

Biochim Biophys Acta. 2014 May;1844(5):874-83. doi: 10.1016/j.bbapap.2013.12.007. Epub 2013 Dec 17. Review.

PMID:
24361552
19.

Statistical issues in the validation of prognostic, predictive, and surrogate biomarkers.

Sargent DJ, Mandrekar SJ.

Clin Trials. 2013 Oct;10(5):647-52. doi: 10.1177/1740774513497125. Epub 2013 Aug 27.

PMID:
23983158
20.

Prevention of alcohol misuse among children, youths and young adults.

Korczak D, Steinhauser G, Dietl M.

GMS Health Technol Assess. 2011;7:Doc04. doi: 10.3205/hta000095. Epub 2011 Jul 22.

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