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Items: 1 to 20 of 34

1.

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.

2.

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. Review.

PMID:
22181041
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. Review.

4.

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. Review.

5.

Implementing prognostic and predictive biomarkers in CRC clinical trials.

Van Schaeybroeck S, Allen WL, Turkington RC, Johnston PG.

Nat Rev Clin Oncol. 2011 Feb 15;8(4):222-32. doi: 10.1038/nrclinonc.2011.15. Review.

PMID:
21321566
6.

Clinical trial designs for predictive marker validation in cancer treatment trials.

Sargent DJ, Conley BA, Allegra C, Collette L.

J Clin Oncol. 2005 Mar 20;23(9):2020-7. Review.

PMID:
15774793
7.

Designing a definitive trial for adjuvant targeted therapy in genotype defined lung cancer: the ALCHEMIST trials.

Alden RS, Mandrekar SJ, Oxnard GR.

Chin Clin Oncol. 2015 Sep;4(3):37. doi: 10.3978/j.issn.2304-3865.2015.09.03. Review.

8.

Biomarkers for Assessing and Managing Iron Deficiency Anemia in Late-Stage Chronic Kidney Disease [Internet].

Chung M, Moorthy D, Hadar N, Salvi P, Iovin RC, Lau J.

Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Oct.

9.

Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials.

Anglemyer A, Horvath HT, Bero L.

Cochrane Database Syst Rev. 2014 Apr 29;(4):MR000034. doi: 10.1002/14651858.MR000034.pub2. Review.

PMID:
24782322
10.

Challenges and methodology in the incorporation of biomarkers in cancer clinical trials.

Wilhelm-Benartzi CS, Mt-Isa S, Fiorentino F, Brown R, Ashby D.

Crit Rev Oncol Hematol. 2017 Feb;110:49-61. doi: 10.1016/j.critrevonc.2016.12.008. Review.

PMID:
28109405
11.

Biomarkers predicting clinical outcome of epidermal growth factor receptor-targeted therapy in metastatic colorectal cancer.

Siena S, Sartore-Bianchi A, Di Nicolantonio F, Balfour J, Bardelli A.

J Natl Cancer Inst. 2009 Oct 7;101(19):1308-24. doi: 10.1093/jnci/djp280. Review.

12.

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. Review.

PMID:
24361552
13.

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. Review.

PMID:
25921239
14.

Drug-diagnostic co-development: challenges and issues.

Shimazawa R, Ikeda M.

Expert Rev Mol Diagn. 2016;16(2):187-204. doi: 10.1586/14737159.2016.1132163. Review.

PMID:
26651878
15.

Biomarkers as point-of-care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care.

Aabenhus R, Jensen JU, Jørgensen KJ, Hróbjartsson A, Bjerrum L.

Cochrane Database Syst Rev. 2014 Nov 6;(11):CD010130. doi: 10.1002/14651858.CD010130.pub2. Review.

PMID:
25374293
16.

Improving Clinical Trial Efficiency: Thinking outside the Box.

Mandrekar SJ, Dahlberg SE, Simon R.

Am Soc Clin Oncol Educ Book. 2015:e141-7. doi: 10.14694/EdBook_AM.2015.35.e141. Review.

17.

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.

18.

Personalized medicine in non-small-cell lung cancer: is KRAS a useful marker in selecting patients for epidermal growth factor receptor-targeted therapy?

Roberts PJ, Stinchcombe TE, Der CJ, Socinski MA.

J Clin Oncol. 2010 Nov 1;28(31):4769-77. doi: 10.1200/JCO.2009.27.4365. Review.

PMID:
20921461
19.

American Society of Clinical Oncology provisional clinical opinion: testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy.

Allegra CJ, Jessup JM, Somerfield MR, Hamilton SR, Hammond EH, Hayes DF, McAllister PK, Morton RF, Schilsky RL.

J Clin Oncol. 2009 Apr 20;27(12):2091-6. doi: 10.1200/JCO.2009.21.9170. Review.

PMID:
19188670
20.

Evidence Brief: The Quality of Care Provided by Advanced Practice Nurses.

McCleery E, Christensen V, Peterson K, Humphrey L, Helfand M.

VA Evidence-based Synthesis Program Evidence Briefs [Internet]. Washington (DC): Department of Veterans Affairs (US); 2011-.
2014 Sep.

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