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Original Articles

Continual Reassessment Method vs. Traditional Empirically Based Design: Modifications Motivated by Phase I Trials in Pediatric Oncology by the Pediatric Brain Tumor Consortium

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Pages 437-455 | Published online: 21 Apr 2009

REFERENCES

  • Fitzpatrick , S. , Scott , A. ( 1987 ). Quick simultaneous confidence intervals for multinomial proportions . JASA 82 : 875 – 878 .
  • Goodman , S. N. , Zahurak , M. L. , Piantadosi , S. ( 1995 ). Some practical improvements in the continual reassessment method for Phase I studies . Stat. Med. 14 : 1149 – 1161 .
  • Heyd , J. , Carlin , B. ( 1999 ). Adaptive design improvements in the continual reassessment method for Phase I studies . Stat. Med. 18 : 1307 – 1321 .
  • Kasahara , K. , Myo , S. , Iwasa , K. , Kimura , H. , Shirasaki , H. , Yasuda , U. , Shibata , K. , Shintani , H. , Nishi , K. , Fujimura , M. , Nakao , S. ( 2002 ). A Phase I study of carboplatin and docetaxel for advanced non–small cell lung cancer using the continual reassessment method . Japanese J. Clin. Oncol. 32 : 512 – 516 .
  • Korn , E. L. , Midthune , D. , Chen , T. T. , Rubinstein , L. V. , Christian , M. C. , Simon , R. M. (1994). A comparison of two Phase I trial designs. Stat. Med. , Sept. 30, 13(18): 1799–1806.
  • Lee , D. P. , Skolnik , J. M. , Adamson , P. C. ( 2005 ). Pediatric Phase I trials in oncology: An analysis of study conduct efficiency . J. Clin. Oncol. 23 : 8431 – 8441 .
  • Lin , Y. , Shih , W. J. ( 2001 ). Statistical properties of the traditional algorithm-based designs for Phase I cancer clinical trials . Biostatistics 2 : 203 – 215 .
  • Marsoni , S. , Ungerleider , R. S. , Hurson , S. B. , Simon , R. M. , Hammershaimb , L. D. ( 1985 ). Tolerance to antineoplastic agents in children and adults . Cancer Treat. Reports 69 : 1263 – 1269 .
  • O'Quigley , J. ( 2002 ). Continual reassessment designs with early termination . Biostatistics 3 : 87 – 99 .
  • O'Quigley , J. , Shen , L. Z. ( 1996 ). Continual reassessment method: A likelihood approach . Biometrics 52 : 673 – 684 .
  • O'Quigley , J. , Reiner , E. ( 1998 ). A stopping rule for the continual reassessment method . Biometrika 85 : 741 – 748 .
  • O'Quigley , J. , Pepe , M. , Fisher , L. ( 1990 ). Continual reassessment method: A practical design for Phase I clinical studies in cancer . Biometrics 46 : 33 – 48 .
  • Piantadosi , S. , Liu , G. ( 1996 ). Improved designs for dose escalation studies using pharmacokinetic measurements . Stat. Med. 15 : 1605 – 1618 .
  • Piantadosi , S. , Fisher , J. D. , Grossman , S. ( 1998 ). Practical implementation of a modified continual reassessment method for dose finding trials . Cancer Chemother. Pharmacol. 41 : 429 – 436 .
  • Royce , M. E. , Hoff , P. M. , Dumas , P. , Lassere , Y. , Lee , J. J. , Coyle , J. , Ducharme , M. P. , De Jager , R. , Pazdur , R. ( 2001 ). Phase I and pharmacokinetic study of exatecan mesylate (DX-8951f): a novel camptothecin analog . J. Clin. Oncol. 19 : 1493 – 1500 .
  • Schoffski , P. , Riggert , S. , Fumoleau , P. , Campone , M. , Bolte , O. , Marreaud , S. , Lacombe , D. , Baron , B. , Herold , M. , Zwierzina , H. , Wilhelm-Ogunbiyi , K. , Lentzen , H. , Twelves , C. ( 2004 ). Phase I trial of intravenous aviscumine (rViscumin) in patients with solid tumors: a study of the European Organization for Research and Treatment of Cancer New Drug Development Group . Ann. Oncol. 15 : 1816 – 1824 .
  • Shen , L. Z. , O'Quigley , J. ( 1996 ). Consistency of continual reassessment method under model misspecification . Biometrika 83 : 395 – 405 .
  • Smith , M. , Bernstein , M. , Bleyer , W. A. , Borsi , J. D. , Ho , P. , Lewis , I. J. , Pearson , A. , Pein , F. , Pratt , C. , Reaman , G. , Riccardi , R. , Seibel , N. , Trueworthy , R. , Ungerleider , R. , Vassal , G. , Vietti , T. ( 1998 ). Conduct of Phase I trials in children with cancer . J. Clin. Oncol. 16 : 966 – 978 .
  • Storer , B. ( 1989 ). Design and analysis of Phase I clinical trials . Biometrics 45 : 925 – 937 .
  • Thall , P. F. , Lee , J. J. , Tseng , C. , Etsey , E. H. ( 1999 ). Accrual strategies for Phase I trials with delayed patient outcome . Stat. Med. 18 : 1155 – 1169 .

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