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Items: 1 to 20 of 94

1.

Validation of novel imaging methodologies for use as cancer clinical trial end-points.

Sargent DJ, Rubinstein L, Schwartz L, Dancey JE, Gatsonis C, Dodd LE, Shankar LK.

Eur J Cancer. 2009 Jan;45(2):290-9. doi: 10.1016/j.ejca.2008.10.030. Epub 2008 Dec 16.

2.

The power of phase II end-points for different possible mechanisms of action of an experimental treatment.

Wason JM, Dentamaro A, Eisen TG.

Eur J Cancer. 2015 May;51(8):984-92. doi: 10.1016/j.ejca.2015.03.002. Epub 2015 Mar 31.

3.

Alternative clinical end points in rectal cancer--are we getting closer?

Glynne-Jones R, Mawdsley S, Pearce T, Buyse M.

Ann Oncol. 2006 Aug;17(8):1239-48.

PMID:
16873440
4.

Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke.

Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B, Barr J, Dillon W, Warach S, Broderick J, Tilley B, Sacks D; Technology Assessment Committee of the American Society of Interventional and Therapeutic Neuroradiology.; Technology Assessment Committee of the Society of Interventional Radiology..

Stroke. 2003 Aug;34(8):e109-37. Epub 2003 Jul 17. Erratum in: Stroke. 2003 Nov;34(11):2774.

5.

A method for utilizing co-primary efficacy outcome measures to screen regimens for activity in two-stage Phase II clinical trials.

Sill MW, Rubinstein L, Litwin S, Yothers G.

Clin Trials. 2012 Aug;9(4):385-95. doi: 10.1177/1740774512450101. Epub 2012 Jul 18.

6.

Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system.

Hudis CA, Barlow WE, Costantino JP, Gray RJ, Pritchard KI, Chapman JA, Sparano JA, Hunsberger S, Enos RA, Gelber RD, Zujewski JA.

J Clin Oncol. 2007 May 20;25(15):2127-32.

PMID:
17513820
7.

Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.

Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group..

J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.

8.

New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J.

Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

PMID:
19097774
9.

INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.

[No authors listed]

Drugs R D. 2007;8(3):176-87. Review.

PMID:
17472413
10.

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
11.

Novel designs and end points for phase II clinical trials.

Adjei AA, Christian M, Ivy P.

Clin Cancer Res. 2009 Mar 15;15(6):1866-72. doi: 10.1158/1078-0432.CCR-08-2035. Epub 2009 Mar 10. Review.

12.

Lessons learned from independent central review.

Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J.

Eur J Cancer. 2009 Jan;45(2):268-74. doi: 10.1016/j.ejca.2008.10.031.

PMID:
19101138
13.

Designing exploratory cancer trials using change in tumour size as primary endpoint.

Jaki T, André V, Su TL, Whitehead J.

Stat Med. 2013 Jul 10;32(15):2544-54. doi: 10.1002/sim.5716. Epub 2012 Dec 19.

PMID:
23280944
14.

Optimising the design of phase II oncology trials: the importance of randomisation.

Ratain MJ, Sargent DJ.

Eur J Cancer. 2009 Jan;45(2):275-80. doi: 10.1016/j.ejca.2008.10.029. Epub 2008 Dec 6.

PMID:
19059773
15.

Appropriate end-points for right results in the age of antiangiogenic agents: future options for phase II trials in patients with recurrent glioblastoma.

Brandes AA, Franceschi E, Gorlia T, Wick W, Jacobs AH, Baumert BG, van den Bent M, Weller M, Stupp R; European Organisation for Research and Treatment of Cancer Brain Tumour Group..

Eur J Cancer. 2012 Apr;48(6):896-903. doi: 10.1016/j.ejca.2011.10.027. Epub 2011 Nov 24. Review.

PMID:
22119352
16.

Clinical trial design in small cell lung cancer: surrogate end points and statistical evolution.

Nickolich M, Babakoohi S, Fu P, Dowlati A.

Clin Lung Cancer. 2014 May;15(3):207-12. doi: 10.1016/j.cllc.2013.12.001. Epub 2013 Dec 27.

PMID:
24485231
17.
18.

Progression-free survival rate as primary end point for phase II cancer clinical trials: application to mesothelioma--The EORTC Lung Cancer Group.

Francart J, Legrand C, Sylvester R, Van Glabbeke M, van Meerbeeck JP, Robert A.

J Clin Oncol. 2006 Jul 1;24(19):3007-12.

PMID:
16809726
19.

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.

PMID:
16192604
20.

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