Clinical Trials in Oncology: Third Edition

Clinical Trials in Oncology: Third Edition

Volumn , Issue , 2012, Pages 1-243

  Green, Stephanie ^a   Benedetti, Jacqueline ^a   Smith, Angela ^a   Crowley, John ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85152339037     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b12125     Document Type: Book

References (327)

1. Aickin M. Randomization, balance, and the validity and efficiency of design-adaptive allocation methods. Journal of Statistical Planning and Inference 94:97-119, 2001.
2. Alberts D. S., Green S., Hannigan E. V., O’Toole R., Stock-Novak D., Anderson P., Surwit E. A., Malviya V. K., Nahhas W. A., and Jolles C. J. Improved therapeutic index of carboplatin plus cyclophosphamide versus cisplatin plus cyclophosphamide:Final report by the Southwest Oncology Group of a phase III randomized trial in stages III and IV ovarian cancer. Journal of Clinical Oncology 10:706-717, 1992.
3. Alizadeh A. A., Eisen M. B., Davis R. E., Ma C., Lossos I. S., Rosenwald A., Boldrick J. C., Sabet H., Tran T., Yu X., Powell J. I., Yand L., Marti G. E., Moore T., Hudson J. Jr., Lu L., Lewis D. B., Tibshirani R., Sherlock G., Chan W. C., Greiner T. C., Weisenburger D. D., Armitage J. O., Warnke R., Levy R., Wilson W., Grever M. R., Byrd J. C., Botstein D., Brown P. O., and Staudt L. M. Distinct types of diffuse large B-cell lymphoma identified by gene expression profiling. Nature 403:503-511, 2000.
4. Altaman L. US Halts Recruitment of Cancer Patients for Studies, Pointing to Flaws in Oversight. New York Times, Wed. March 30, p A-12, 1994.
5. Anderson J. R., Cain K. C., and Gelber R. D. Analysis of survival by tumor response. Journal of Clinical Oncology 1:710-719, 1983.
6. Anderson P. K. Conditional power calculations as an aid in the decision whether to continue a clinical trial. Controlled Clinical Trials 8:67-74, 1987.
7. Anderson G. L., LeBlanc M., Liu P. Y., and Crowley J. On use of covariates in randomization and analysis of clinical trials. In Handbook of Statistics in Clinical Oncology, 2nd edition. J. Crowley and D. P. Ankerst (eds.). Boca Raton, FL: Chapman and Hall/CRC Press, pp 167-180, 2006.
8. Antman K., Crowley J., Balcerzak S. P., Rivkin S. E., Weiss G. R., Elias A., Natale R. B., et al. An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. Journal of Clinical Oncology 11:1276-1285, 1993.
9. Babb J., Rogatko A., and Zacks S. Cancer phase I clinical trials: Efficient dose escalation with overdose control. Statistics in Medicine 17:1103-1120, 1998.
10. Balcerzak S., Benedetti J., Weiss G. R., and Natale R. B. A phase II trial of paclitaxel in patients with advanced soft tissue sarcomas: A Southwest Oncology Group study. Cancer 76:2248-2252, 1995.
11. Barlogie B., Anderson K., Berenson J., Crowley J., Cunningham D., Gertz M., Henon P., et al. In K. Dicke and A. Keeting (eds.): Autologous Marrow and Blood Transplantation. Proceedings of the Seventh International Symposium. Arlington, TX. pp 399-410, 1995.
12. Barlogie B., Kyle R., Anderson K., Greipp P., Lazarus H., Hurd D., McCoy J., et al. Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: Final results of phase III US intergroup trial S9321. Journal of Clinical Oncology 24:929-935, 2006.
13. Bartlett R., Roloff D., Cornell R., Andrews A., Dillon P., and Zwischenberger J. Extracorporeal circulation in neonatal respiratory failure: A prospective randomized study. Pediatrics 76:476-487, 1985.
14. Battaille R., Durie B. G. M., and Grenier J. Serum beta-2 microglobulin and survival duration in multiple myeloma: A simple reliable marker for staging. British Journal of Haematology 55:439-447, 1983.
15. Bauer P. and Kieser M. Combining different phase in the development of medical treatments within a single trial. Statistics in Medicine 18:1833-1848, 1999.
16. Begg C. B. and Kalish L. A. Treatment allocation for nonlinear models in clinical trials:The logistic model. Biometrics 40:409-420, 1984.
17. Bekele B. and Shen Y. ABayesian approach to jointly modeling toxicity and biomarker expression in a Phase I/II dose-finding trial. Biometrics 61:344-354, 2005.
18. Benedetti J. K., Liu P.-Y., Sather H., Seinfeld H., and Epson M. Effective sample size for censored survival data. Biometrika 69:343-349, 1982.
19. Berlin J., Stewart J. A., Storer B., Tutsch K. D., Arzoomanin R. Z., Alberti D., Feierabend C., Simon K., and Wilding G. Phase I clinical and pharmacokinetic trial of penclomedine using a novel, two-stage trial design for patients with advanced malignancy. Journal of Clinical Oncology 16:1142-1149, 1998.
20. Bernard C. L. Introduction a l’Etude de la Médecine Expérimentale. 1866, reprinted, Garnier-Flammarion, London 1966.
21. Bernstein D. and Lagakos S. Sample size and power determination for stratified clinical trials. Journal of Statistical Computations and Simulation 8:65-73, 1978.
22. Berry D. A. Adaptive clinical trials: The promise and the caution. Journal of Clinical Oncology 29:606-609, 2011.
23. Biagi J. J., Raphael M. J., Mackillop W. J., Kong W., King W. D., and Booth C. M. Association between time to initiation of adjuvant chemotherapy and survival in colorectal cancer: A systematic review and meta-analysis. Journal of the American Medical Association 305:2335-2342, 2011.
24. Blackwelder W. C. “Proving the null hypothesis” in clinical trials. Controlled Clinical Trials 3:345-353, 1982.
25. Blumenstein B. A. The relational database model and multiple multicenter clinical trials. Controlled Clinical Trials 10:386-406, 1989.
26. Boissel J.-P. Impact of randomized clinical trials on medical practices. Controlled Clinical Trials 10:120S-134S, 1989.
27. Bonadonna G. and Valagussa P. Dose-response effect of adjuvant chemotherapy in breast cancer. New England Journal of Medicine 34:10-15, 1981.
28. Boutron I., Estellat C., and Ravaud P. A review of blinding in randomized controlled trials found results inconsistent and questionable. Journal of Clinical Epidemiology 58:1220-1226, 2005.
29. Breiman L., Friedman J. H., Olshen R. A., and Stone C. J. Classification and Regression Trees. Belmont, CA:Wadsworth International Group, 1984.
30. Breslow N. and Crowley J. Large sample properties of the life table and PL estimates under random censorship. Annals of Statistics 2:437-453, 1972.
31. Brookmeyer R. and Crowley J. A confidence interval for the median survival time. Biometrics 38:29-41, 1982.
32. Bryant J. and Day R. Incorporating toxicity considerations into the design of two-stage phase II clinical trials. Biometrics 51:1372-1383, 1995.
33. Budd G. T., Green S., O’Bryan R. M., Martino S., Abeloff M. D., Rinehart J. J., Hahn R., et al. Short-course FAC-M versus 1 year of CMFVP in node-positive, hormone receptor-negative breast cancer: An intergroup study. Journal of Clinical Oncology 13:831-839, 1995.
34. Bunn P. A., Crowley J., Kelly K., Hazuka M. B., Beasley K., Upchurch C., and Livingston R. Chemoradiotherapy with or without granulocyte-macrophage colony-stimulating factor in the treatment of limited-stage small-cell lung cancer:A prospective Phase III randomized study of the Southwest Oncology Group. Journal of Clinical Oncology 13:1632-1641, 1995.
35. Burkhardt B., Woessmann W., Zimmermann M., Kontny U., Vormoor J., Doerffel W., Mann G., et al. Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative Stage III or IV lymphoblastic lymphoma. Journal of Clinical Oncology 24:491-499, 2006.
36. Burris H. A., Moore M. J., Andersen J., Green M. R., Rothenberg M. L., Modiano M. R., Cripps M. C., et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer; a randomized trial. Journal of Clinical Oncology 15:2403-2417, 1997.
37. Buyse M. and Molenberghs G. Criteria for the validation of surrogate endpoints in randomized experiments. Biometrics 54:1014-1029, 1998.
38. Byar D. P., Simon R. M., Friedewalde W. T., Schlesselman J. J., DeMets D. L., Ellenberg J. H., Gail M. H., and Ware J. H. Randomized clinical trials: Perspectives on some recent ideas. New England Journal of Medicine 295:74-80, 1976.
39. Chang M., Therneau T., Wieand H. S., and Cha S. Designs for group sequential Phase II clinical trials. Biometrics 43:865-874, 1987.
40. Chang M. N. and O’Brien P. C. Confidence intervals following group seqential tests. Controlled Clinical Trials 7:18-26, 1986.
41. Chang M., Devidas M., and Anderson J. One- and two-stage designs for phase II window studies. Statistics in Medicine 26:2604-2614, 2007.
42. Chen T. and Simon R. Extension of one-sided test to multiple treatment trials. Controlled Clinical Trials 15:124-134, 1994.
43. Cheung C., Liu Y., Wong K., Chan H., Chan Y., Wong H., Chak W., et al. Can daclizumab reduce acute rejection and improve long-term renal function in tacrolimus-based primary renal transplant recipients? Nephrology 13:251-255, 2008.
44. Christian M. C., McCabe M. S., Korn E. L., Abrams J. S., Kaplan R. S., and Friedman M. A. The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06. New England Journal of Medicine 333:1469-1474, 1995.
45. Chu P.-L., Lin Y., and Shih W. J. Unifying CRM and EWOC designs for phase I cancer clinical trials. Journal of Statistical Planning and Inference 139:1146-1163, 2009.
46. Ciampi A., Thiffault J., Nakache J.-P., and Asselain B. Stratification by stepwise regression, correspondence analysis and recursive partitioning. Computatutional Statistics and Data Analysis 4:185-204, 1986.
47. Clark D. A., Stinson E. B., Griepp R. B., Schroeder J. S., Shumway N. E., and Harrison D. C. Cardiac transplantation in man, VI. Prognosis of patients selected for cardia transplantation. Annals of Internal Medicine 75:15-21, 1971.
48. Cobo M., Isla D., Massuti B., Montes A., Sanchez J. M., Provencio M., Viñolas N., et al. Customizing cisplatin based on quantitative excision repair cross-complementing 1 mRNA expression: A phase III trial in non-small-cell lung cancer. Journal of Clinical Oncology 25:2747-2754, 2007.
49. Collins J. M., Zaharko D. S., Dedrick R. L., and Chabner B. A. Potential roles for preclinical pharmacology in Phase I clinical trials. Cancer Treatment Reports 70:73-80, 1986.
50. Collins J. M., Grieshaber C. K., and Chabner B. A. Pharmacologically guided Phase I clinical trials based upon preclinical drug development. Journal of the National Cancer Institute 82:1321-1326, 1990.
51. Collins J. M. Innovations in Phase I design: Where do we go next? Clinical Cancer Research 6:3801-3802, 2000.
52. Collins R. and MacMahon S. Reliable assessment of the effects of treatment on mortality and major morbidity, I: Clinical trials. Lancet 357: 373-380, 2001.
53. Conaway M. R. and Petroni G. R. Bivariate sequential designs for phase II trials. Biometrics 51:656-664, 1995.
54. Concorde Coordinating Committee. Concorde: MRC/ANRS randomized doubleblind controlled trial of immediate and deferred zidovudine in symtom-free HIV infection. Lancet 343:871-881, 1994.
55. Cook R. J. and Farewell V. T. Guidelines for monitoring efficacy and toxicity response in clinical trials. Biometrics 50:1146-1152, 1994.
56. Cooper R., Holland J., and Glidewell O. Adjuvant chemotherapy of breast cancer. Cancer 44:793-798, 1979.
57. Coronary Drug Project Research Group. Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. New England Journal of Medicine 303:1038-1041, 1980.
58. Cowan J. D., Green S., Neidhart J., McClure S., Coltman C. Jr., Gumbart C., Martino S., et al. Randomized trial of doxorubicin, bisantrene and mitoxantrone in advanced breast cancer. A Southwest Oncology Group study. Journal of the National Cancer Institute 83:1077-1084, 1991.
59. Cox D. R. Regression models and life-tables (with discussion). Journal of the Royal Statistical Society, Series B 34:187-220, 1972.
60. Crowley J. and Breslow N. Statistical analysis of survival data. Annual Review of Public Health 5:385-411, 1984.
61. Crowley J. Perioperative portal vein chemotherapy. In ASCO Educational Book, 30th Annual Meeting, Dallas, TX, 1994.
62. Crowley J., Green S., Liu P.-Y., and Wolf M. Data monitoring committees and early stopping guidelines: The Southwest Oncology Group experience. Statistics in Medicine 13:1391-1399, 1994.
63. Crowley J., LeBlanc M., Gentleman R., and Salmon S. Exploratory methods in survival analysis. In H. L. Koul and J.V. Deshpande, Eds. Analysis of Censored Data.Hayward, CA: IMS Lecture Notes-Monograph Series 27:55-77, 1995.
64. Crowley J., LeBlanc M., Jacobson J., and Salmon S. E. Some exploratory methods for survival data. In D.-Y. Lin and T. R. Fleming, Eds. Proceedings of the First Seattle Symposium on Biostatistics. Springer-Verlag, 1997.
65. De Moulin, D. AShort History of Breast Cancer. Dordrecht Germany: Kluwer Academic, 1989.
66. DeMets D. L., Fleming T. R., Whitley R., Childress J. F., Ellenberg S. S., Foulkes M., Mayer K. H., et al. The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) trials. Controlled Clinical Trials 16:408-421, 1995.
67. Dees E. C., Whitfield L. R., Grove W. R., Rummel S., Grochow L. B., and Donehower R. C. A phase I and pharmacologic evaluation of the DNA intercalator CI-958 in patients with advanced solid tumors. Clinical Cancer Research 6:3801-3802, 2000.
68. Diem K. and Lentner C. (eds.). Scientific Tables. Basel, Switzerland: J. R. Geigy, 1970.
69. Dimond E. G., Kittle C. F., and Crockett J. E. Comparison of internal mammary artery ligation and sham operation for angina pectoris. American Journal of Cardiology 5:483-486, 1960.
70. Dixon D. and Simon R. Sample size consideration for studies comparing survival curves using historical controls. Journal of Clinical Epidemiology 41:1209-1213, 1988.
71. Dmitrienko A., Tamhane A., Bretz F. (eds.). Multiple Testing Problems in Pharmaceutical Statistics. Boca Raton, FL: Chapman and Hall/CRC, 2009.
72. Dodd L. E., Korn E. L., Friedlin B., Jaffee C. C., Rubenstein L.V., Dancey J., and Mooney M. M. Blinded independent central review of progression-free survival in phase III oncology trials: Important design element or unnecessary expense? Journal of Clinical Oncology 26:3791-3796, 2008.
73. Draper N. R. and Smith H. Applied Regression Analysis. New York: Wiley, 1968.
74. Duffy D. E. and Santner T. J. Confidence intervals for a binomial parameter based on multistage tests. Biometrics 43:81-94, 1987.
75. Durie B. G. M. and Salmon S. E. A clinical system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment and survival. Cancer 36:842-854, 1975.
76. Durie B. G. M., Dixon D. O., Carter S., Stephens R., Rivkin S., Bonnet J., Salmon S. E., Dabich L., Files J. C., and Costanzi J. Improved survival duration with combination induction for multiple myeloma: A Southwest Oncology Group study. Journal of Clinical Oncology 4:1227-1237, 1986.
77. Duvillard E. E. Analyse et tableaux de l’influence de la petite vérole sur la mortalité a chaque age, et de celle qu’un préservatif tel que la vaccine peut avoir sur la population et la longevité. Paris: Imprimerie Imperiale, 1806.
78. Echt D. S., Liebson P. R., Mitchell L. B. et al. Mortality and morbidity in patients receiveing ecainide, flecainide or placebo: The Cardiac Arrythmia Suppression Trial. New England Journal of Medicine 324:781-788, 1991.
79. Ederer F. Jerome Cornfield’s contributions to the conduct of clinical trials. Biometrics (Supplement) 38:25-32, 1982.
80. Edge S. B., Byrd D. R., Compton C. C., Fritz A. G., Greene F. L., and Trotti A. (eds.). AJCC Cancer Staging Manual, 7th ed. New York: Springer, 2010.
81. Eisenhauer E. A., O’Dwyer P. J., Christian M., and Humphrey J. S. Phase I clinical trial design in cancer drug development. Journal of Clinical Oncology 18:684-692, 2000.
82. Eisenhauer E. A., Therasse P., Bogaert J., Schwartz L. H., Sargent D., Ford R., Dancey J., et al. Newresponse evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). European Journal of Cancer 45:228-247, 2009.
83. Ellenberg S. Randomization designs in comparative clinical trials. New England Journal of Medicine 310:1404-1408, 1984.
84. Ellenberg S. S., Finkelstein D. M., and Schoenfeld D. A. Statistical issues arising in AIDS clinical trials. Journal of the American Statistical Association 87:562-569, 1992.
85. Faraggi D., LeBlanc M., and Crowley J. Understanding neural networks using regression trees: An application to multiple myeloma survival data. Statistics in Medicine 20:2965-2976, 2001.
86. Fisher B. Winds of change in clinical trials-from Daniel to Charlie Brown. Controlled Clinical Trials 4:65-74, 1983.
87. Fisher R., Gaynor E., Dahlberg S., Oken M., Grogan T., Mize E., Glick J., Coltman C., and Miller T. Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin’s lymphoma. New England Journal of Medicine 328:1002-1006, 1993.
88. Fleiss J. L. Statistical Methods for Rates and Proportions, 2nd ed. New York: Wiley, 1981.
89. Fleiss J. L., Tytun A., and Ury H. K. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics 36:343-346, 1980.
90. Fleming T. Onesample multiple testing procedures for Phase II clinical trials. Biometrics 38:143-151, 1982.
91. Fleming T. R. Evaluating therapeutic interventions: Some issues and experiences. Statistical Science 7:428-456, 1992.
92. Fleming T., Green S., and Harrington P. Considerations for monitoring and evaluating treatment effects in clinical trials. Controlled Clinical Trials 5:55-66, 1984.
93. Fleming T. R. Interpretation of subgroup analyses in clinical trials. Drug Information Journal 29:1681S-1687S, 1995.
94. Food and Drug Administration. Guidance for Industry: E10. Choice of control group and related issues in clinical trials. Office of Training and Communication. Center for Drug Evaluation and Research. Rockville MD, 2001.
95. Food and Drug Administration Guidance for Industry: Noninferiority clinical trials. Draft, 2010.
96. Freeman T., Vawtner D., Leaverton P., Godbold J., Hauser R., Goetz C., and Olanow C. W. Use of placebo surgery in controlled trials of a cellular based therapy for Parkinson’s disease. New England Journal of Medicine 341:988-992, 1999.
97. Frei E. III, Holland J. F., Schneiderman M. A., Pinkel D., Selkirk C., Freireich E. J., Silver R. T., Gold C. L., and Regelson W. A comparative study of two regimens of combination chemotherapy in acute leukemia. Blood 13:1126-1148, 1958.
98. Frytak S., Moertel C., O’Fallon J., Rubin J., Creagan E., O’Connel M., Schutt A., and Schwartau N. Delta-9-Tetrahydrocannabinol as an antiemetic for patients receiving cancer chemotherapy. Annals of Internal Medicine 91:825-830, 1979.
99. Gail M. H. Statistics in action. Journal of the American Statistical Association 91:1-13, 1996.
100. Gallo P., Chuang-Stein C., Dragalin V., Gaydos B., Krams M., and Pinheiro J. Adaptive designs in clinical drug development-and executive summary of the PhRMA working group. Journal of Biopharmaceutical Statistics 16:275-283, 2006.
101. Gandara D. R., Crowley J., Livingston R. B., Perez E. A., Taylor C.W., Weiss G., Neefe J. R., et al. Evaluation of cisplatin in metastatic non-small cell lung cancer:Aphase III study of the Southwest Oncology Group. Journal of Clinical Oncology 11:873-878, 1993.
102. Gehan E. A generalizedWilcoxon test for comparing arbitrarily singly-censored samples. Biometrika 52:203-223, 1965.
103. Gelmon K., Latreille J., Tolcher A., Génier L., Fisher B., Forand D., D’Aloisio S., et al. Phase I dose-finding study of a new taxane, RPR 109881A, administered as a onehour intravenous infusion days 1 and 8 to patients with advanced solid tumors. Journal of Clinical Oncology 18:4098-108, 2000.
104. Gentleman R. and Crowley J. Local full likelihood estimation for the proportional hazards model. Biometrics 47:1283-1296, 1991a.
105. Gentleman R. and Crowley J. Graphical methods for censored data. Journal of the American Statistical Association 86:678-682, 1991b.
106. George S. Asurvey of monitoring practices in cancer clinical trials. Statistics in Medicine 12:435-450, 1993.
107. Gil Deza E., Balbiani L., Coppola F., Blajman C., Block J. F., Giachella O., Chacon R., Capo A., Zori Comba A., Fein L., Polera L., Matwiejuk M., Jaremtchuk A., Muro H., Reale M., Bass C., Chiesa G., Van Koten M., and Schmilovich A. Phase III study of navelbine (NVB) vs NVB plus cisplatin in non small cell lung cancer (NSCLC) Stage IIIB or IV. Proceedings of ASCO 15:39 (#1193), 1996.
108. Gilbert J. P., McPeek B., and Mosteller F. Statistics and ethics in surgery and anesthesia. Science 198:684-689, 1977.
109. Gold P. J., Goldman B., Iqbal S., Leichman L. P., Zhang W., Lenz H. J., and Blanke C. D. Cetuximab as second-line therapy in patients with metastatic esophageal adenocarcinoma: A phase II Southwest Oncology Group Study (S0415). Journal of Thoracic Oncology 5:1472-1476, 2010.
110. Goldberg K. B. and Goldberg P. (eds.). Four Patients in Tamoxifen Treatment Trial Had Died of Uterine Cancer Prior to BCPT. The Cancer Letter, April 29, 1994.
111. Goldie J. H., Coldman A. J., and Gudauskas G. A. Rationale for the use of alternating non-cross-resistant chemotherapy. Cancer Treatment Reports 66:439-449, 1982.
112. Goldman B., LeBlanc M., and Crowley J. Interim futility analysis with intermediate endpoints. Clinical Trials 5:14-22, 2008.
113. Golub T. R., Slonim D. K., Tamoyo P., Huard C., Gaasenbeck M., Mesiriv J. P., Coller H., Loh M. L., Dowving J. R., Caliguri M. A., Bloomfield C. D., and Lander E. S. Molecular classification of cancer: Class discovery and class prediction by gene expression monitoring. Science 286:531-537, 1999.
114. Goodman S. N., Zahurak M. L., and Piantadoosi S. Some practical improvements in the continual reassessment method for phase I studies. Statisitics in Medicine 14:1149-1161, 1995.
115. Gooley T., Martin P., Fisher L., and Pettinger M. Simulation as a design tool for Phase I/II clinical trials: An example from bone marrow transplantation. Controlled Clinical Trials 15:450-462, 1994.
116. Gooley T., Leissenring W., Crowley J., and Storer B. Estimation of failure probabilities in the presence of competing risks:Newrepresentations of old estimators. Statistics in Medicine 18:695-706, 1999.
117. Gordon R. The Alarming History of Medicine. New York: St. Martin’s Press, 1993.
118. Gray R. J. A class of K-sample tests for comparing the cumulative incidence of a competing risk. The Annals of Statistics 16:1141-1154, 1988.
119. Green S. and Crowley J. Data monitoring committees for Southwest Oncology Group trials. Statistics in Medicine 12:451-455, 1993.
120. Green S. and Dahlberg S. Planned versus attained design in Phase II clinical trials. Statistics in Medicine 11:853-862, 1992.
121. Green S. J., Fleming T. R., and O’Fallon J. R. Policies for study monitoring and interim reporting of results. Journal of Clinical Oncology 5:1477-1484, 1987.
122. Green S. J., Fleming T. R., and Emerson S. Effects on overviews of early stopping rules for clinical trials. Statistics in Medicine 6:361-367, 1987.
123. Green S. Factorial designs with time to event endpoints. In Handbook of Statistics in Clinical Oncology, 2nd ed, J. Crowley and D. P. Ankerst (eds.). Boca Raton, FL: CRC Press, pp 181-190, 2006.
124. Green S. and Weiss G. Southwest Oncology Group standard response criteria, endpoint definitons and toxicity criteria. Investigational New Drugs 10:239-253, 1992.
125. Greipp P. R., San Miguel J., Durie B. G. M., Crowley J. J., Barlogie B., Blade J., Boccadoro M., et al. International staging system for multiple myeloma. Journal of Clinical Oncology 23:1-9, 2005.
126. Harrington D., Crowley J., George S., Pajak T., Redmond C., and Wieand S. The case against independent monitoring committees. Statistics in Medicine 13:1411-1414, 1994.
127. Harrington D., Fleming T., and Green S. Procedures for serial testing in censored survival data, in J. J. Crowley and R. A. Johnson (eds.) Survival Analysis. Hayward, CA: IMS Lecture Notes Monograph Series, 2:269-286, 1982.
128. Hawkins B. S. Data monitoring committees for multicenter clinical trials sponsored by the National Institutes of Health: Roles and membership of data monitoring committees for trials sponsored by the National Eye Institute. Controlled Clinical Trials 12:424-437, 1991.
129. Haybittle J. L. Repeated assessments of results in clinical trials of cancer treatment. British Journal of Radiology 44:793-797, 1971.
130. Heath E. I., LoRusso P. M., Ivy S. P., Rubinstein L., Christian M. C., and Heilbrun L. K. Theoretical and practical application of traditional and accelerated titration Phase I clinical trial designs: The Wayne State University experience. Journal of Biopharmaceutical Statistics 19:414-423, 2009.
131. Hellman S. and Hellman D. S. Of mice but not men: Problems of the randomized clinical trial. New England Journal of Medicine 324:1585-1589, 1991.
132. Henderson I. C., Hayes D., and Gelman R. Dose-response in the treatment of breast cancer: A critical review. Journal of Clinical Oncology 6:1501-1515, 1988.
133. Herbst R. S., Kelly K., Chansky K., Mack P. C., Franklin W. A., Hirsch F.R., Atkins J.N., et al. Phase II selection design of concurrent chemotherapy and cetuximab versus chemotherqapy followed by cetuximab in advanced-stage non-small-cell lung cancer: Southwest Oncology Study S0342. Journal of Clinical Oncology 28:4747-4754, 2010.
134. Hill A. B. Principles of Medical Statistics. London: Lancet, 1937.
135. Hill A. B. Memories of the British streptomycin trial in tuberculosis. Controlled Clinical Trials 11:77-79, 1990.
136. Hoering A., LeBlanc M., and Crowley J. Randomized phase III clinical trial designs for targeted agents. Clinical Cancer Research 14:4358-4367, 2008.
137. Hoering A., LeBlanc M., and Crowley J. Seamless phase I/II trial design for assessing toxicity and efficacy for targeted agents. Clinical Cancer Research 17:640-646, 2011.
138. Hogan J. W. and Laird N. M. Mixture models for the joint distribution of repeated measures and event times. Statistics in Medicine 16:239-257, 1997.
139. Horstmann E., McCabe M., Grochow L., Yamamoto S., Rubinstein L., Budd T., Shoemaker D., Emanuel E., and Grady C. Risks and benefits of Phase 1 oncology trials, 1991-2002. New England Journal of Medicine 352:895-904, 2005.
140. Hróbjartsson A., Forfang E., Haahr M., Als-Nielsen B., and Brorson S. Blinded trials taken to the test: An analysis of randomized clinical trials that report tests for the success of blinding. International Journal of Epidemiology 36:654-663, 2007.
141. Hryniuk W. and Levine M. N. Analysis of dose intensity for adjuvant chemotherapy trials in stage II breast cancer. Journal of Clinical Oncology 4:1162-1170, 1986.
142. Hsieh F.-Y., Crowley J., and Tormey D. C. Some test statistics for use in multistate survival analysis. Biometrika 70:111-119, 1983.
143. Huang B. and Chappell R. Three-dose-cohort designs in cancer phase I trials. Statistics in Medicine 27:2070-2093, 2008.
144. Huff D. How to Lie with Statistics. New York: Norton, 1954.
145. Hunsberger S., Rubinstein L. V., Dancey J., and Korn E. L. Dose escalation trial designs based on a molecularly targeted endpoint. Statistics in Medicine 24:2171-2181, 2005.
146. Hunsberger S., Zhao Y., and Simon R. A comparison of phase II study strategies. Clinical Cancer Research 15:5950-5955, 2009.
147. Inoue L.Y., Thall P. F., and Berry D. A. Seamlessly expanding a phase II trial to phase III. Biometrics 58:823-831, 2002.
148. ISIS-2 Collaborative Group. Randomized trial of intravenous streptokinase, oral aspirin, both, or neither among 17, 187 cases of suspected acute myocardial infarction:ISIS-2. Lancet 332:349-60, 1988.
149. Ivanova A., Montazer-Haghighi A., Mohanty S. G., and Durham S. D. Improved upand- down designs for phase I trials. Statistics in Medicine 22:69-82, 2003.
150. Jennison C. and Turnbull B. W. Confidence intervals for a binomial parameter following a multistage test with application to MIL-STD 105D and medical trials. Technometrics 25:49-58, 1983.
151. Jung S.-H. and Kim K. M. On the estimation of the binomial probability in multistage clinical trials. Statistics in Medicine 23:881-896, 2004.
152. Kalbfleisch J. D. and Prentice R. L. The Statistical Analysis of Failure Time Data. New York:Wiley, 1980.
153. Kaplan E. L. and Meier P. Nonparametric estimation from incomplete observations. Journal of the American Statistical Association 53:457-481, 1958.
154. Kassirer J. P. Clinical trials and meta-analysis: What they do for us. (editorial) New England Journal of Medicine 325:273-274, 1992.
155. Kelly K., Crowley J., Bunn P. A., Hazuka M., Beasley K., Upchurch C., Weiss G., et al. Role of recombinant interferon alfa-2a maintenance in patients with limited-stage small-cell lung cancer responding to concurrent chemoradiation:ASouthwest Oncology Group study. Journal of Clinical Oncology 13:2924-2930, 1995.
156. Khan J., Wei J. S., Ringner M., Saal L. H., Ladanyi M., Westerman F., Berthold F., Schwab M., Antonescu C. R., Peterson C., and Meltzer P. S. Classification and diagnostic prediction of cancers using gene expression profiling and artificial neural networks. Nature Medicine 7:673-679, 2001.
157. Kies M. S., Mira J., Chen T., and Livingston R. B. Value of chest radiation therapy in limited small cell lung cancer after chemotherapy induced complete disease remission (for the Southwest Oncology Group). (abstract) Proceedings of the American Society of Clinical Oncology 1:141(C-546), 1982.
158. Kies M. S., Mira J., Crowley J., Chen T., Pazdur R., Grozea P., Rivkin S., Coltman C., Ward J. H., and Livingston R. B. Multimodal therapy for limited small cell lung cancer: A randomized study of induction combination chemotherapy with or without thoracic radiation in complete responders; and with wide field versus reduced-field radiation in partial responders:ASouthwest Oncology Group study. Journal of Clinical Oncology 5:592-600, 1987.
159. Kieser M. and Friede T. Simple procedures for blinded sample size adjustment that do not affect the type I error rate. Statistics in Medicine 22:3571-3581, 2003.
160. Kim E. S., Herbst R. S., Wistuba I. I., Lee J. J., Blumenschein G. R. Jr., Tsao A., Stewart D. J., et al. TheBATTLEtrial: Personalizing therapy for lung cancer. Cancer Discovery 1:43-51, 2011.
161. Kindler H. L., Friberg G., Singh D. A., Locker G., Nattam S., Kozloff M., Taber D. A., et al. Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. Journal of Clinical Oncology 23:8033-8040, 2005.
162. Kindler H. L., Niedzwiecki D., Hollis D., Sutherland S., Schrag D., Hurwitz H., Innocenti F., et al. Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: Phase III trial of the Cancer and Leukemia Group B (CALGB 80303). Journal of Clinical Oncology 28:3617-3622, 2010.
163. Klimt C. R. Varied acceptance of clinical trial results. Controlled Clinical Trials 10 (Supplement):1355-1415, 1989.
164. Kopecky K. K. and Green S. Noninferiority trials. In Handbook of Statistics in Clinical Oncology, 2nd ed. J. Crowley and D. P. Ankerst (eds.). Boca Raton, FL: CRC Press, pp 191-206, 2006.
165. Korn E. L. and Friedlin B. Outcome-adpative randomization: Is it useful? Joural of Clinical Oncology 29:771-776, 2011.
166. Lamm D. L., Blumenstein B. A., Crawford E. D., Crissman J. D., Lowe B. A., Smith J. A., Sarosdy M. F., et al. Randomized intergroup comparison of bacillus Calmette-Guerin immunotherapyandmitomycinCchemotherapy prophylaxis in superficial transitional cell carcinoma of the bladder: A Southwest Oncology Group study. Urologic Oncology 1:119-126, 1995.
167. Lan K. and DeMets D. Changing frequency of interim analysis in sequential monitoring. Biometrics 45:1017-1020, 1989.
168. Lan K., Simon R., and Halperin, M. Stochastically curtailed test in long-term clinical trials. Sequential Analysis 1:207-219, 1982.
169. Lancaster H. O. Quantitative Methods in Biological and Medical Sciences. New York:Springer-Verlag, 1994.
170. Laurie J. A., Moertel C. G., Fleming T. R., Wieand H. S., Leigh J. E., Rubin J., McCormack G.W., et al. Surgical adjuvant therapy of large-bowel carcinoma: An evaluation of levamisole and the combination of levamisole and fluorouracil. Journal of Clinical Oncology 7:1447-1456, 1989.
171. LeBlanc M. and Crowley J. Relative risk trees for censored survival data. Biometrics 48:411-425, 1992.
172. LeBlanc M. and Crowley J. Survival trees by goodness of split. Journal of the American Statistical Association 88:457-467, 1993.
173. LeBlanc M., Jacobson J., and Crowley J. Partitioning and peeling for constructing prognostic groups. Statistical Methods in Medical Research 11:1-28, 2002.
174. LeBlanc M., Rankin C., and Crowley J. Multiple histology phase II trials. Clinical Cancer Research 15:4256-4262, 2009.
175. Lee J. and Tseng C. Uniform power method for sample size calculation in historical control studies with binary response. Controlled Clinical Trials 22:390-400, 2001.
176. Leichman C. G., Fleming T. R., Muggia F. M., Tangen C. M., Ardalan B., Doroshow J. H., Meyers F. J., et al. Phase II study of fluorouracil and its modulation in advanced colorectal cancer: A Southwest Oncology Group study. Journal of Clinical Oncology 13:1301-1311, 1995.
177. Lind J. A Treatise of the Scurvy. Edinburgh: Sands, Murray, and Cochran, 1753.
178. Lin X., Allred A., and Andrews G. A two-stage phase II trial design utilizing both primary and secondary endpoints. Pharmaceutical Statististics 7:88-92, 2008.
179. Liu P.-Y. and Dahlberg S. Design and analysis of multiarm clinical trials with survival endpoints. Controlled Clinical Trials 16:119-130, 1995.
180. Liu P.-Y., Dahlberg S., and Crowley J. Selection designs for pilot studies based on survival endpoints. Biometrics 49:391-398, 1993.
181. Liu P.-Y., Voelkel J., Crowley J., and Wolf M. Sufficient conditions for treatment responders to have longer survival than non-responders. Statistics and Probability Letters 18:205-208, 1993.
182. Liu P.-Y, Tsai W.-Y., and Wolf M. Design and analysis for survival data under order restrictions:Amodified ordered logrank test. Statistics in Medicine 17:1469-79, 1998.
183. Liu P. Y., Moon J., and LeBlanc M. Phase II Selection designs. In Handbook of Statistics in Clinical Oncology, 2nd ed. J. Crowley and D. P. Ankerst (eds.) Boca Raton, FL:CRC Press, pp 155-166, 2006.
184. Liu Q. and Pledger G. Phase 2 and combination designs to accelerate drug development. Journal of the American Statistical Association 100:493-502, 2005.
185. Liver Infusion Meta-Analysis Group. Portal vein infusion of cytotoxic drugs after colorectal cancer surgery: A meta-analysis of 10 randomised studies involving 4000 patients. Journal of the National Cancer Institute 89:497-505, 1997.
186. London W. and Chang M. One- and two-stage designs for stratifed phase II clinical trials. Statistics in Medicine 24:2597-2611, 2005.
187. Louvet C., Lledo T. A., Hammel P., Bleiberg H., Bouleuc C., Gamelin E., Flesch M., Cvitkovic E., and de Gramont A. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: Final results of aGERCORmulticenter phase II study. Journal of Clinical Oncology 20:1512-1518, 2002.
188. Louvet C., Labianca R., Hammel P., Lledo G., Zampino M. G., Andre A., Zaniboni A., et al. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: Results of a GERCOR and GISCAD phase III trial. Journal of Clinical Oncology 23:3509-3516, 2005.
189. Macdonald J. S., Smalley, S. R., Benedetti J., Hundahl S. A., Estes N. C., Stemmerman G. N., Haller D. G., Ajani J. A., Gunderson L. L., Jessup J. M., and Martenson J. A. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. New England Journal of Medicine 345:725-730, 2001.
190. Machtay M., Kaiser L. R., and Glatstein E. Is meta-analysis really meta-physics? Chest 116:539-544, 1999.
191. Mackillop W. J. and Johnston P. A. Ethical problems in clinical research: The need for empirical studies of the clinical trials process. Journal of Chronic Diseases 39:177-188, 1986.
192. Macklin R. The ethical problems with sham surgery in clinical research. New England Journal of Medicine 341:992-996, 1999.
193. Makuch R. and Simon R. Sample size consideration for non-randomized comparative studies. Journal of Chronic Diseases 33:175-181, 1980.
194. Mandrekar S. J. and Sargent D. J. Randomized phase II trials: Time for a new era in clinical trial design. Journal of Thoracic Oncology 5:932-934, 2010.
195. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemotherapy Reports 50:163-170, 1966.
196. Margolin K. M., Green S., Osborne K., Doroshow J. H., Akman S. A., Leong L. A., Morgan R. J., et al. Phase II trial of 5-fluorouracil and high-dose folinic acid as first- or second-line therapy for advanced breast cancer. American Journal of Clinical Oncology 17:175-180, 1994.
197. Markman, Maurie. Letter to the editor. Serious ethical dilemma of single-agent pegylated liposomal doxorubicin employed as a control arm in ovarian cancer chemotherapy trials. Journal of Clinical Oncology 28:e319-e320, 2010.
198. Marubini E. and Valsecchi M. G. Analysing Survival Data from Clinical Trials and Observational Studies. New York:Wiley, 1995.
199. McCracken D., Janaki L. M., Crowley J., Taylor S. A., Giri P. G., Weiss G. B., Gordon J. W., Baker L. H., Mansouri A., and Kuebler J. P. Concurrent chemotherapy/ radiotherapy for limited small-cell carcinoma: A Southwest Oncology Group study. Journal of Clinical Oncology 8:892-898, 1990.
200. McFadden E. T., LoPresti F., Bailey L. R., Clarke E., and Wilkins P. C. Approaches to data management. Controlled Clinical Trials 16:30S-65S, 1995.
201. Meier P. Statistics and medical experimentation. Biometrics 31:511-529, 1975.
202. Miller T. P., Crowley J., Mira J., Schwartz J. G., Hutchins L., Baker L., Natale R., Chase E. M., and Livingston R. A randomized trial of treatment of chemotherapy and radiotherapy for stage III non-small cell lung cancer. Cancer Therapeutics 1:229-236, 1998.
203. Mira J. G., Kies M. S., and Chen T. Influence of chest radiotherapy in response, remission duration, and survival in chemotherapy responders in localized small cell lung carcinoma: A Southwest Oncology Group Study. Proceedings of the American Society of Clinical Oncology 3:212 (C-827), 1984.
204. Moeller S. Anextension of the continual reassessment methods using a preliminary upand- down design in a dose finding study in cancer patients, in order to investigate a greater range of doses. Statistics in Medicine 14:911-922, 1995.
205. Moertel C. G., Fleming T. R., MacDonald J. S., Haller D. G., Laurie J. A., Goodman P. J., Ungerleider J. S., et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. New England Journal of Medicine 322:352-358, 1990.
206. Moher D., Hopewell S., Schulz K. F., Montori V., Gøtzsche P. C., Devereaux P. J., Elbourne D., Egger M., and Altman D. G. for the CONSORT Group. CONSORT 2010 Explanation and elaboration: Updated guidelines for reporting parallel group randomised trial. British Medical Journal 340:c869, 2010.
207. Moinpour C., Feigl P., Metch B., Hayden K., Meyskens F., and Crowley J. Quality of life end points in cancer clinical trials: Review and recommendations. Journal of the National Cancer Institute 81:485-496, 1989.
208. Moinpour C. M. Costs of quality of life research in Southwest Oncology Group trials. Monographs of the Journal of the National Cancer Institute 20:11-16, 1996.
209. Moinpour C., Triplett J., McKnight B., Lovato l., Upchurch C., Leichman C., Muggia F., et al. Challenges posed by non-random missing quality of life data in an advanced stage colorectal cancer clinical trial. Psycho-Oncology 9:340-354, 2000.
210. Monro A. Collections of blood in cancerous breasts. In Monro A. TheWorks of Alexander Monro. Edinburgh: Ch Elliot, 1781.
211. Norfolk D., Child J. A., Cooper E. H., Kerrulsh S., and Milford-Ward A. Serum β2 microglobulin in myelomatosis: Potential value in stratification and monitoring. British Journal of Cancer 42:510-515, 1980.
212. O’Brien P. Procedures for comparing samples with multiple endpoints. Biometrics 40:1079-1087, 1984.
213. Olanow C.W., Goetz C., Kordower J., Stoessl A. J., Sossi V, Brin M., Shannon K., et al. A double-blind controlled trial of bilateral fetal nigral transplantation in Parkinson’s disease. Annals of Neurology 54:403-414, 2003.
214. O’Malley J., Normand S.-L., and Kuntz R. Sample size calculation for a historically controlled clinical trial with adjustment for covariates. Journal of Biopharmaceutical Statistics 12:227-247, 2002.
215. O’Quigley J., Pepe M., and Fisher L. Continual reassessment method: A practical design for Phase I clinical trials. Biometrics 46:33-48, 1990.
216. O’Quigley J., Hughes M., and Fenton T. Dose-finding for HIV studies. Biometrics 57:1018-1029, 2001.
217. O’Quigley J. Dose finding designs using continual reassessment methods. In Handbook of Statistics in Clinical Oncology, 3rd ed., Crowley J. and Hoering A. (eds.)NewYork:Marcel Dekker, 2011.
218. Panageas K., Smith A., Gönen M., and Chapman P. An optimal two-stage phase II design utilizing complete and partial response information separately. Controlled Clinical Trials 23:367-379, 2002.
219. Passamani E. Clinical trials-are they ethical? New England Journal of Medicine 324:1589-1592, 1991.
220. Pater J. and Crowley J. Sequential randomization. In Handbook of Statistics in Clinical Oncology, 2nd ed. J. Crowley and D. P. Ankerst, (eds.). Boca Raton, FL: CRC Press, pp 589-596, 2006.
221. Penel N., Isambert N., Leblond P., Ferte C., Duhamel A., and Bonneterre J. “Classical 3 + 3 design” versus “accelerated titration designs”: Analysis of 270 phase 1 trials investigating anti-cancer agents. Investigational New Drugs 27:552-556, 2009.
222. Permutt T. Testing for imbalance of covariates in controlled experiments. Statistics in Medicine 9:1455-1462, 1990.
223. Pérol M., Léna H., Thomas P., Robinet G., Fournel P., Coste E., Belleguic C., et al. Phase II randomized multicenter study evaluating a treatment regimen alternating docetaxel and cisplatin-vinorelbine with a cisplatin-vinorelbine control group in patients with stage IV non-small-cell lung cancer: GFPC 97.01 study. Annals of Oncology 13:742-747, 2002.
224. Peterson B. and George S. L. Sample size requirements and length of study for testing interaction in a 2×k factorial design when time to failure is the outcome. Controlled Clinical Trials 14:511-522, 1993.
225. Peto R. and Peto J. Asymptotically efficient rank invariant test procedures. Journal of the Royal Statistical Society, Series A 135:185-198, 1972.
226. Peto R., Pike M. C., Armitage P., Breslow N. E., Cox D. R., Howard S. V., Mantel N., McPherson K., Peto J., and Smith P. G. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. British Journal of Cancer 34:585-612, 1976.
227. Philip P. A., Benedetti J., Corless C. L., Wong R., O’Reilly E. M., Flynn P. J., Rowland K. M., et al. Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-Directed intergroup trial S0205. Journal of Clinical Oncology 28:3605-3610, 2010.
228. Piantadosi S. Clinical Trials: A Methodological Perspective. Hoboken, NJ: Wiley, 2005.
229. Pocock S. J. and Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31:348-361, 1975.
230. Poplin E., Feng Y., Berlin J., Rothenberg M. L., Hochster H., Mitchell E., Alberts S., et al. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infustion) compared with gemcitabine (30-minute infustion) in patients with pancreatic carcinoma E6201: A trial of the Eastern Cooperative Oncology Group. Journal of Clinical Oncology 27:3778-3785, 2009.
231. Prentice R. L. Linear rank tests with right censored data. Biometrika 65:167-179, 1978.
232. Prentice R. L., Kalbfleisch J. D., Peterson A. V. Jr., Flournoy N., Farewell V. T., and Breslow N. E. The analysis of failure times in the presence of competing risks. Biometrics 34:541-554, 1978.
233. Prentice R. L. Surrogate endpoints in clinical trials: Discussion, definition and operational criteria. Statistics in Medicine 8:431-440, 1989.
234. Pritza D. R., Bierman M. H., and Hammeke M. D. Acute toxic effects of sustainedrelease verapamil in chronic renal failure. Archives of Internal Medicine 151:2081-2084, 1991.
235. Quackenbush J. Computational analysis of microarray data. Nature Reviews 2:418-427, 2001.
236. Redman M. and Crowley J. Small randomized trials. Journal of Thoracic Oncology 2:1-2, 2007.
237. Redman M. Early stopping of clinical trials. In Handbook of Statistics in Clinical Oncology. J. Crowley and A. Hoering (eds.). Boca Raton, FL: Chapman and Hall/CRC Press, 2012.
238. Redmond C., Fisher B., and Wieand H. S. The methodologic dilemma in retrospectively correlating the amount of chemotherapy received in adjuvant therapy protocols with disease-free survival. Cancer Treatment Reports 67:519-526, 1983.
239. Rivkin S. E., Green S., Metch B., Glucksberg H., Gad-el-Mawla N., Constanzi J. J., Hoogstraten B., et al. Adjuvant CMFVP versus melphalan for operable breast cancer with positive axillary nodes: 10-year results of a Southwest Oncology Group study. Journal of Clinical Oncology 7:1229-1238, 1989.
240. Rivkin S. E., Green S., Metch B., Jewell W., Costanzi J., Altman S., Minton J., O’Bryan R., and Osborne C. K. One versus 2 years of CMFVP adjuvant chemotherapy in axillary node-positive and estrogen receptor negative patients:ASouthwest Oncology Group study. Journal of Cinical Oncology 11:1710-1716, 1993.
241. Rivkin S. E., Green S., Metch B., Cruz A. B., Abeloff A. M., Jewell W. R., Costanzi J. J., Farrar W. B., Minton J. P., and Osborne C. K. Adjuvant CMFVP versus tamoxifen versus concurrent CMFVP and tamoxifen for postmenopausal, node-positive and estrogen-receptor positive breast cancer patients: A Southwest Oncology Group study. Journal of Clinical Oncology 12:2078-2085, 1994.
242. Rivkin S. E., Green S., O’Sullivan J., Cruz A., Abeloff M. D., Jewell W. R., Costanzi J. J., Farra W. B., and Osborne C. K. Adjuvant CMFVP plus ovariechtomy for premenopausal, node-positive and estrogen receptor-positive breast cancer patients:A Southwest Oncology Group study. Journal of Clinical Oncology 14:46-51, 1996.
243. Rockhold F. W. and Enas G. G. Data monitoring and interim analysis in the pharmaceutical industry: Ethical and logistical considerations. Statistics in Medicine 12:471-479, 1993.
244. Rosner B. Fundamentals of Biostatistics, 2nd ed. Boston: Duxbury, 1986.
245. Rothwell P. Subgroup analysis in randomized controlled trials: Importance, indications and interpretation. Lancet 365:176-186, 2005.
246. Royall R. Ethics and statistics in randomized clinical trials. Statistical Science 6:52-88, 1991.
247. Royston P., Parmar M. K. B., and Qian W. Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer. Statististics in Medicine 22:2239-2256, 2003.
248. Rubinstein L. V., Korn E. L., Friedlin B., Hunsberger S., Ivy S. P., and Smith M. A. Design issues of randomized phase II trials and a proposal for phase II screening trials. Journal of Clinical Oncology 23:7199-7206, 2005.
249. Rubinstein L. V., Crowley J., Ivy P., LeBlanc M., and Sargent D. J. Randomized phase II designs. Clinical Cancer Research 15:1883-1890, 2009.
250. Salmon S. E., Haut A., Bonnet J. D., Amare M., Weick J. K., Durie B. G. M., and Dixon D. O. Alternating combination chemotherapy and levamisole improves survival in multiple myeloma:ASouthwest Oncology Group study. Journal of Clinical Oncology 1:453-461, 1983.
251. Salmon S. E., Tesh D., Crowley J., Saeed S., Finley P., Milder M. S., Hutchins L. F., et al. Chemotherapy is superior to sequential hemibody irradiation for remission consolidation in multiple myeloma: A Southwest Oncology Group study. Journal of Clinical Oncology 8:1575-1584, 1990.
252. Salmon S. E., Crowley J., Grogan T. M., Finley P., Pugh R. P., and Barlogie B. Combination chemotherapy, glucocorticoids, and interferon alpha in the treatment of multiple myeloma:ASouthwest Oncology Group study. Journal of Clinical Oncology 12:2405-2414, 1994.
253. Salmon S. E., Crowley J. J., Balcerzak S. P., Roach P. W., Taylor S. A., Rivkin S. E., and Samlowski W. Interferon versus interferon plus prednisone remission maintenance therapy for multiple myeloma: A Southwest Oncology Group study. Journal of Clinical Oncology 16:890-896, 1998.
254. Sargent D. F., Wieand S., Haller D. G., Gray R., Benedetti J., Buyse M., Labianca R., et al. Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: Individual patient data from 20, 898 patients on 18 randomized trials. Journal of Clinical Oncology 23:8664-8670, 2005.
255. Sargent D. J., Conley B. A., Allegra C., and Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. Journal of Clinical Oncology 9:2020-2027, 2005.
256. Sasieni P. D. and Winnett A. Graphical approaches to exploring the effects of prognostic factors on survival. In Handbook of Statistics in Clinical Oncology, 1st edition. J. Crowley (ed.). Boca Raton, FL: Chapman and Hall/CRC Press, pp 433-456, 2001.
257. Schaid D., Wieand S., and Therneau T. Optimal two-stage screening designs for survival comparisons. Biometrika 77:507-513, 1990.
258. Schemper M. and Smith T. L. A note on quantifying follow-up in studies of failure time. Controlled Clinical Trials 17:343-346, 1996.
259. Schoenfeld D. Sample-size formula for the proportional-hazards regression model. Biometrics 39:499-503, 1983.
260. Schulz K. F., Altman D. G., and Moher D. for the CONSORT Group. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. British Medical Journal 340:c332, 2010.
261. Schumacher M., Holländer N., Schwarzer G., and Sauerbrei W. Prognostic factor studies. In Handbook of Statistics in Clinical Oncology, 2nd edition. J. Crowley and D. P. Ankerst, (eds.). Boca Raton, FL: Chapman and Hall/CRC Press, pp 289-334, 2006.
262. Segal M. R. Regression trees for censored data. Biometrics 44:35-48, 1988.
263. Sessa C., Capri G., Gianni L., Peccatori F., Grasselli G., Bauer J., Zucchetti M., et al. Clinical and pharmacological phase I study with accelerated titration design of a daily times five schedule of BBR3436, a novel cationic triplatinum complex. Annals of Oncology 11:977-983, 2000.
264. Shapiro A. and Shapiro K. The Powerful Placebo: From Ancient Priest to Modern Physician. Baltimore, MD: Johns Hopkins University Press, 1997.
265. Shepherd F. A., Pereira J., Ciuleanu T. E., Tan E. H., Hirsh V., Thongprasert S., Campos D., et al. for the National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. New England Journal of Medicine 353:123-132, 2005.
266. Silverman W. A. and Chalmers I. Sir Austin Bradford Hill: An appreciation. Controlled Clinical Trials 13:100-105, 1991.
267. Silverman W. A. Doctoring: From art to engineering. Controlled Clinical Trials 13:97-99, 1992.
268. Simon R. and Wittes R. E. Methodologic guidelines for reports of clinical trials. (editorial) Cancer Treatment Reports 69:1-3, 1985.
269. Simon R. How large should a Phase II trial of a new drug be? Cancer Treatment Reports 71:1079-1085, 1987.
270. Simon R. Optimal two-stage designs for Phase II clinical trials. Controlled Clinical Trials 10:1-10, 1989.
271. Simon R. Practical aspects of interim monitoring of clinical trials. Statistics in Medicine 13:1401-1409, 1994.
272. Simon R. and Ungerleider R. Memorandum to Cooperative Group Chairs, 1992.
273. Simon R., Wittes R., and Ellenberg S. Randomized Phase II clinical trials. Cancer Treatment Reports 69:1375-1381, 1985.
274. Simon R., Friedlin B., Rubenstein L., Arbuck S., Collins J., and Christian M. Accelerated titration designs for phase I clinical trials in oncology. Journal of the National Cancer Institute 89:1138-1147, 1997.
275. Simon R. and Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clinical Cancer Research 10:6759-6763, 2004.
276. Slamon D. J., Leyland-Jones B., Shak S., Fuchs H., Paton V., Bajamonde A., Fleming T., et al. Use of chemotherapy plus a monoclonal antibody againstHER2for metastatic breast cancer that overexpresses HER2. New England Journal of Medicine 344:783-792, 2001.
277. Slud E. Analysis of factorial survival experiments. Biometrics 50:25-38, 1994.
278. Smith J. Patenting the Sun: Polio and the Salk Vaccine. New York:William Morrow, 1990.
279. Smith J. S. Remembering the role of Thomas Francis, Jr. in the design of the 1954 Salk vaccine trial. Controlled Clinical Trials 13:181-184, 1992.
280. Spiegelhalter D. J., Freedman L. S., and Blackburn P. R. Monitoring clinical trials:Conditional or predictive power? Controlled Clinical Trials 7:8-17, 1986.
281. Sposto R. and Gaynon P. An adjustment for patient heterogeneity in the design of two-stage phase II trials. Statistics in Medicine 28:2566-2579, 2009.
282. Stallard N. and Todd S. Sequential designs for phase III clinical trials incorporating treatment selection. Statistics in Medicine 22:689-703, 2003.
283. Stewart David J., Whitney Simon N., and Kurzrock Razelle. Equipoise lost: Ethics, costs, and the regulation of cancer clinical research. Journal of Clinical Oncology 28:2925-2935, 2010.
284. Storer B. Design and analysis of Phase I clinical trials. Biometrics 45:925-938, 1989.
285. Storer B. Choosing a Phase I design. In Handbook of Statistics in Clinical Oncology, 3rd ed. J. Crowley and A. Hoering (eds.). New York: Marcel Dekker, 2011.
286. Stuart C. P. and Guthrie D. (eds.). Lind’s Treatise on Scurvy. Edinburgh: University Press, 1953.
287. Stuart K. E., Hajdenberg A., Cohn A., Loh K. K., Miller W., White C., and Clendinnin N. J. Aphase II trial of ThymitaqTM (AG337) in patients with hepatocellular carcinoma (HCC). Proceedings of the American Society of Clinical Oncology 15:202 (#449), 1996.
288. Tang D.-I., Gnecco C., and Geller N. Design of group sequential clinical trials with multiple endpoints. Journal of the American Statistical Association 84:776-779, 1989.
289. Tang H., Foster N. R., Grothey A., Ansell S. M., Goldberg R. M., and Sargent D. J. Comparison of error rates in single-arm versus randomized phase II cancer clinical trials. Journal of Clinical Oncology 28:1936-1941, 2009.
290. Tangen C. M. and Crowley J. Phase II trials using time-to-event endpoints. In Handbook of Statistics in Clinical Oncology, 2nd ed. J. Crowley and D. P. Ankerst (eds.). Boca Raton, FL: CRC Press, pp 143-154, 2006.
291. Taube S. E., Jacobson J. W., and Lively T. G. Cancer diagnostics: Decision criteria for marker utilization in the clinic. American Journal of Pharmacogenomics 5:357-364, 2005.
292. Taylor I., Rowling J., and West C. Adjuvant cytotoxic liver perfusion for colorectal cancer. British Journal of Surgery 66:833-837, 1979.
293. Taylor I., Machin D., and Mullee M. A randomized controlled trial of adjuvant portal vein cytotoxic perfusion in colorectal cancer. British Journal of Surgery 72:359-363, 1985.
294. Taylor J. M., Braun T. M., and Li Z. Comparing an experimental agent to a standard agent: Relative merits of a one-arm or randomized two-arm Phase II design. Clinical Trials 3:335-348, 2006.
295. Thall P., Simon R., and Ellenberg S. Two-stage selection and testing designs for comparative clinical trials. Biometrika 75:303-310, 1988.
296. Thall P. F. and Estey E. H. Graphical methods for evaluating covariate effects in the Cox model. In Handbook of Statistics in Clinical Oncology, 1st edition. J. Crowley (ed.). Boca Raton, FL: Chapman and Hall/CRC Press, pp 411-432, 2001.
297. Thall P. F. and Russell K. E. A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics 54:251-264, 1998.
298. Thall P. and Cook J. Dose-finding based on efficacy-toxicity trade-offs. Biometrics 60:684-693, 2004.
299. Thall P., Cook J., and Estey E. Adaptive dose selection using efficacy-toxicity tradeoffs:Illustrations and practical considerations. Journal of Biopharmaceutical Statistics 16:623-638, 2006.
300. Thall P. F., Wathen K. J., Bekele B. N., Champlin R. E., Baker L. O., and Benjamin R. S. Hierarchical Bayesian approaches to phase II trials in diseases with multiple subtypes. Statistics in Medicine 22:763-780, 2003.
301. Therasse P., Arbuck S., Eisenhauer E., Wanders J., Kaplan R., Rubenstein L., Verweij J., et al. New guidelines to evaluate the response to treatment in solid tumors. Journal of the National Cancer Institute 92:205-216, 2000.
302. Therneau T. M. How many stratification factors are “too many” to use in a randomization plan? Controlled Clinical Trials 14:98-108, 1993.
303. Thomas L. The Youngest Science. New York: Viking Press, 1983.
304. Tibshirani R. J. and Hastie T. Local likelihood estimation. Journal of the American Statistical Association 82:559-567, 1987.
305. Tighiouart M., Rogatko A., and Babb J. S. Flexible Bayesian methods for cancer phase I clinical trials. Dose escalation with overdose control. Statistics in Medicine 24:2183-2196, 2005.
306. Troxel A. B., Harrington D. P., and Lipsitz S. R. Analysis of longitudinal data with non-ignorable non-monotone missing values. Applied Statistics 47:425-438, 1998.
307. Tsiatis A. and Mehta C. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 90:367-378, 2003.
308. Ulm K., Seebauer M., Eberle S., Reck M., and Hessler S. Statistical methods to identify predictive factors. In Handbook of Statistics in Clinical Oncology, 2nd edition. J. Crowley and D. P. Ankerst, (eds.). Boca Raton, FL: Chapman and Hall/CRC Press, pp 335-346, 2006.
309. Vermorken J., Trigo R., Koralweski P., Diaz-Rubio E., Rolland F., Knecht R., Amellal N., Schueler A., and Baselga J. Open-label, uncontrolled, multicenter Phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. Journal of Clinical Oncology 25:2171-2177, 2007.
310. Volberding P. A., Lagakos S.W., Koch M. A., and the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Disease. Zidovudine in asymptomatic human immunodeficiency virus infection. New England Journal of Medicine 322:941-949, 1990.
311. Walters L. Data monitoring committees: The moral case for maximum feasible independence. Statistics in Medicine 12:575-580, 1993.
312. Wang R., Lagakos S., and Ware J. Statistics in medicine-reporting of subgroup analyses in clinical trials. New England Journal of Medicine 357:2189-2194, 2007.
313. Weick J. K., Kopecky K. J., Appelbaum F. R., Head D. R., Kingsbury L. L., Balcerzak S. P., Mills G. M., et al. A randomized investigation of high-dose versus standard dose cytosine arabinoside with daunorubicin in patients with previously untreated acute myeloid leukemia: A Southwest Oncology Group study. Blood 88:2841-2851, 1996.
314. Wei L. J. and Durham S. The randomized play-the-winner rule in medical trials. Journal of the American Statistical Association 73:830-843, 1978.
315. Weir C. J. and Lees K. R. Comparison of stratification and adaptive methods for treatment allocation in an acute stroke clinical trial. Statistics in Medicine 22:705-726, 2003.
316. Wolff J. Lehre von den Krebskrankheiten von den ältesten Zeiten bis zur Gegenwart. 4 Teile in 5Bde.Jena: G Fischer, 1907-1928.
317. Wolmark N., Rockette H., and Wickerham D. L. Adjuvant therapy of Dukes’ A, B and C adenocarcinoma of the colon with portal-vein fluorouracil hepatic infusion:Preliminary results of National Surgical Adjuvant Breast and Bowel Project C-02. Journal of Clinical Oncology 8:1466-1475, 1990.
318. Wolmark N., Rockette H., and Fisher B. Adjuvant therapy for carcinoma of the colon:A review of NSABP clinical trial. In Salmon S. (ed). Adjuvant Therapy of Cancer. vol 7. Lippincott, pp 300-307, 1993.
319. World Medical Association General Assembly. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Journal of Internationale Bioethique 15:124-129, 2004.
320. Xiong H. Q., Rosenberg A., LoBuglio A., Schmidt W., Wolff W. S., Deutsch J., Needle M., and Abbruzzese J. L. Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor, in combination with gemcitabine for advanced pancreatic cancer: A multicenter Phase II trial. Journal of Clinical Oncology 22:2610-2616, 2004.
321. Zee B., Melnychuck D., Dancey J., and Eisenhauer E. Multinomial Phase II cancer trials incorporating response and early progression. Journal of Biopharmaceutical Statistics 9:351-363, 1999.
322. Zelen M. A new design for randomized clinical trials. New England Journal of Medicine 300:1242-1246, 1979.
323. Zhan F., Hardin J., Bumm K., Zheng M., Tiand E., Wilson E., Crowley J., Barlogie B., and Shaughnessy J. Molecular profiling of multiple myeloma. Blood 99:1745-1757, 2002.
324. Zhang W., Sargent D., and Mandrekar S. An adaptive dose-finding design incorporating both toxicity and efficacy. Statistics in Medicine 25:2365-2383, 2006.
325. Zia M., Siu L., Pond G., and Chen E. Comparison of outcomes of Phase II studies and subsequent randomized control studies using identical chemotherapy regimens. Journal of Clinical Oncology 23:6982-6991, 2005.
326. Zubrod C. G., Schneiderman M., Frei M. III, Brindley C., Gold L., Shnider B., Oviedo R., Gorman J., Jones R. Jr., Jonsson U., Colsky J., Chalmers T., Ferguson B., Dederick M., Holland J., Selawry O., Regelson W., Lasagna L., and Owens A. H. Jr. Appraisal of methods for the study of chemotherapy of cancer in man: Comparative therapeutic trial of nitrogen mustard and thiophosphoramide. Journal of Chronic Diseases 11:7-33, 1960.
327. Zubrod C. G. Clinical trials in cancer patients:Anintroduction. Controlled Clinical Trials 3:185-187, 1982.