Format
Sort by
Items per page

Send to

Choose Destination

Links from PubMed

Items: 1 to 20 of 58

2.

Alternative strategies in drug development: clinical pharmacological aspects.

Kuhlmann J.

Int J Clin Pharmacol Ther. 1999 Dec;37(12):575-83. Review.

PMID:
10599949
3.

Pharmacogenomic biomarkers.

Kirkwood SC, Hockett RD Jr.

Dis Markers. 2002;18(2):63-71. Review.

4.

Adaptive design clinical trials and trial logistics models in CNS drug development.

Wang SJ, Hung HM, O'Neill R.

Eur Neuropsychopharmacol. 2011 Feb;21(2):159-66. doi: 10.1016/j.euroneuro.2010.09.003. Epub 2010 Oct 8. Review.

PMID:
20933373
5.

Complex disease-associated pharmacogenetics: drug efficacy, drug safety, and confirmation of a pathogenetic hypothesis (Alzheimer's disease).

Roses AD, Saunders AM, Huang Y, Strum J, Weisgraber KH, Mahley RW.

Pharmacogenomics J. 2007 Feb;7(1):10-28. Epub 2006 Jun 13. Review.

PMID:
16770341
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.

Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop.

Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, Gilbert P, Harris S.

Clin Trials. 2012 Dec;9(6):671-80. doi: 10.1177/1740774512461859.

PMID:
23250942
9.

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
10.

Statistical considerations for the next generation of clinical trials.

Wu W, Shi Q, Sargent DJ.

Semin Oncol. 2011 Aug;38(4):598-604. doi: 10.1053/j.seminoncol.2011.05.014. Review.

PMID:
21810519
11.

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.

12.

The medical and economic roles of pipeline pharmacogenetics: Alzheimer's disease as a model of efficacy and HLA-B(*)5701 as a model of safety.

Roses AD.

Neuropsychopharmacology. 2009 Jan;34(1):6-17. doi: 10.1038/npp.2008.153. Epub 2008 Oct 15. Review.

13.

Biomarkers, validation and pharmacokinetic-pharmacodynamic modelling.

Colburn WA, Lee JW.

Clin Pharmacokinet. 2003;42(12):997-1022. Review.

PMID:
12959633
14.

Validation of pharmacogenomic biomarker classifiers for treatment selection.

Simon R.

Cancer Biomark. 2006;2(3-4):89-96. Review.

PMID:
17192063
15.

Adaptive design methods in clinical trials - a review.

Chow SC, Chang M.

Orphanet J Rare Dis. 2008 May 2;3:11. doi: 10.1186/1750-1172-3-11. Review.

16.

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.

17.

A clinical development paradigm for cancer vaccines and related biologics.

Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, Nichol G; Cancer Vaccine Clinical Trial Working Group.

J Immunother. 2007 Jan;30(1):1-15. Review.

PMID:
17198079
18.

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.

19.

Review of draft FDA adaptive design guidance.

Cook T, DeMets DL.

J Biopharm Stat. 2010 Nov;20(6):1132-42. doi: 10.1080/10543406.2010.514455. Review.

PMID:
21058109
20.

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

Supplemental Content

Support Center