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8 - Design and statistical analysis of clinical trials for glioma therapy

Published online by Cambridge University Press:  05 March 2016

John H. Sampson
Affiliation:
Duke University Medical Center, Durham
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Chapter
Information
The Duke Glioma Handbook
Pathology, Diagnosis, and Management
, pp. 169 - 189
Publisher: Cambridge University Press
Print publication year: 2016

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References

Kaplan, EL, Meier, P. Nonparametric estimation from incomplete observations. Journal of the American Statistical Association 1958;53(282):457–81.CrossRefGoogle Scholar
Cox, DR. Regression models and life-tables. Journal of the Royal Statistical Society Series B – Statistical Methodology 1972;34(2):187.Google Scholar
Garrett-Mayer, E. The continual reassessment method for dose-finding studies: a tutorial. Clinical Trials 2006;1(1740–5):5771.CrossRefGoogle Scholar
Simon, R. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989;10(1):110.CrossRefGoogle Scholar
O’Quigley, J, Pepe, M, Fisher, L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 1990;46(1):3348.CrossRefGoogle Scholar
Ballman, KV, Buckner, JC, Brown, PD, Giannini, C, Flynn, PJ, LaPlant, BR, Jaeckle, KA. The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme. Neuro-Oncology 2007;9(1):2938.CrossRefGoogle ScholarPubMed
Lamborn, KR, Yung, WK, Chang, SM, Wen, PY, Cloughesy, TF, DeAngelis, LM, et al. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro-Oncology 2008;10(2):162–70.CrossRefGoogle ScholarPubMed
Simon, R, Freidlin, B, Rubinstein, L, Arbuck, SG, Collins, J, Christian, MC. Accelerated titration designs for phase I clinical trials in oncology. Journal of the National Cancer Institute 1997;89(15):1138–47.CrossRefGoogle ScholarPubMed
Ratain, MJ, Humphrey, RW, Gordon, GB, Fyfe, G, Adamson, PC, Fleming, TR, et al. Recommended changes to oncology clinical trial design: revolution or evolution? European Journal of Cancer 2008;44(1):811.CrossRefGoogle ScholarPubMed
Ratain, MJ, Sargent, DJ. Optimising the design of phase II oncology trials: the importance of randomisation. European Journal of Cancer 2009;45(2):275–80.CrossRefGoogle ScholarPubMed
Rubinstein, L, Crowley, J, Ivy, P, Leblanc, M, Sargent, D. Randomized phase II designs. Clinical Cancer Research 2009;15(6):1883–90.CrossRefGoogle ScholarPubMed
Lan, KK, DeMets, DL. Changing frequency of interim analysis in sequential monitoring. Biometrics 1989;45(3):1017–20.CrossRefGoogle ScholarPubMed
O’Brien, PC. Procedures for comparing samples with multiple endpoints. Biometrics 1984;40(4):1079–87.Google ScholarPubMed
Andersen, PK. Conditional power calculations as an aid in the decision whether to continue a clinical trial. Controlled Clinical Trials 1987;8(1):6774.CrossRefGoogle Scholar
Halperin, M, Lan, KK, Ware, JH, Johnson, NJ, DeMets, DL. An aid to data monitoring in long-term clinical trials. Controlled Clinical Trials 1982;3(0197–2456):311–23.CrossRefGoogle ScholarPubMed
Hosmer, DW, Jr., Lemeshow, S, Sturdivant, RX. Applied Logistic Regression, 3rd ed. Hoboken, NJ: John Wiley; 2013.CrossRefGoogle Scholar
Kleinbaum, DG, Klein, M. Logistic Regression: A Self-Learning Text. New York: Springer; 2010.CrossRefGoogle Scholar
Hosmer, DW, Lemeshow, D. Applied Survival Analysis: Regression Modeling of Time-to-Event Data, 2nd ed. Hoboken, NJ: John Wiley; 2008.CrossRefGoogle Scholar
Kleinbaum, DG, Klein, M. Survival Analysis: A Self-Learning Text, 3rd ed. New York: Springer; 2012.CrossRefGoogle Scholar
Friedman, LM, Furberg, C, DeMets, DL. Fundamentals of Clinical Trials, 4th ed. New York: Springer; 2010.CrossRefGoogle Scholar
Green, S, Benedetti, J, Smith, A, Crowley, J. Clinical Trials in Oncology, 3rd ed. Boca Raton, FL: Chapman & Hall; 2012.CrossRefGoogle Scholar
Cheung, YK. Dose Finding by the Continual Reassessment Method. Boca Raton, FL: Chapman & Hall; 2011.CrossRefGoogle Scholar
Chow, S-C, Chang, M. Adaptive Design Methods in Clinical Trials. Boca Raton, FL: Chapman & Hall; 2007.Google Scholar
Chang, M. Adaptive Design Theory and Implementation Using SAS and R. Boca Raton, FL: Chapman & Hall, 2008.Google Scholar
Fairclough, DL. Design and Analysis of Quality of Life Studies in Clinical Trials. Boca Raton, FL: Chapman & Hall, 2010.CrossRefGoogle Scholar

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