메뉴 건너뛰기




Volumn 18, Issue 3, 2004, Pages 373-378

Choice of designs and doses for early phase trials

Author keywords

Dose escalation; First into man; Statistical designs

Indexed keywords

ANTINEOPLASTIC AGENT;

EID: 2942514436     PISSN: 07673981     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1472-8206.2004.00226.x     Document Type: Review
Times cited : (24)

References (37)
  • 2
    • 0025148278 scopus 로고
    • Continual reassessment method: A practical design for phase I clinical trials in cancer
    • O'Quigley J., Pepe M., Fisher L. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics (1990) 46 33-48.
    • (1990) Biometrics , vol.46 , pp. 33-48
    • O'Quigley, J.1    Pepe, M.2    Fisher, L.3
  • 3
    • 0029071328 scopus 로고
    • Bayesian decision procedures for dose determining experiments
    • Whitehead J., Brunier H. Bayesian decision procedures for dose determining experiments. Stat. Med. (1995) 14 885-893.
    • (1995) Stat. Med. , vol.14 , pp. 885-893
    • Whitehead, J.1    Brunier, H.2
  • 5
    • 0003563862 scopus 로고
    • Study design principles for the clinical evaluation of new drugs as developed by the chemotherapy programme of the National Cancer Institute
    • Staquet M.J. (Ed.), Editions Scientifique Europe, Brussels
    • Carter S.K. Study design principles for the clinical evaluation of new drugs as developed by the chemotherapy programme of the National Cancer Institute, in: Staquet M.J. (Ed.), The design of clinical trials in cancer therapy, Editions Scientifique Europe, Brussels, 1973. pp. 242-289.
    • (1973) The Design of Clinical Trials in Cancer Therapy , pp. 242-289
    • Carter, S.K.1
  • 6
    • 0012957270 scopus 로고    scopus 로고
    • Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trials
    • Lin Y., Shih W.J. Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trials. Biostatistics (2001) 2 203-215.
    • (2001) Biostatistics , vol.2 , pp. 203-215
    • Lin, Y.1    Shih, W.J.2
  • 7
    • 0032648126 scopus 로고    scopus 로고
    • Operating characteristics of the standard phase I clinical trial design
    • Reiner E., Paoletti X., O'Quigley J. Operating characteristics of the standard phase I clinical trial design. Comput. Stat. Data Anal. (1999) 30 303-315.
    • (1999) Comput. Stat. Data Anal. , vol.30 , pp. 303-315
    • Reiner, E.1    Paoletti, X.2    O'Quigley, J.3
  • 11
    • 0028060511 scopus 로고
    • Practical modifications of the continual reassessment method for phase I cancer clinical trials
    • Faries D. Practical modifications of the continual reassessment method for phase I cancer clinical trials. J. Biopharm. Stat. (1994) 4 147-164.
    • (1994) J. Biopharm. Stat. , vol.4 , pp. 147-164
    • Faries, D.1
  • 12
    • 0029027770 scopus 로고
    • Some practical improvements in the continual reassessment method for phase I studies
    • Goodman S.N., Zahurak M.L., Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat. Med. (1995) 14 1149-1161.
    • (1995) Stat. Med. , vol.14 , pp. 1149-1161
    • Goodman, S.N.1    Zahurak, M.L.2    Piantadosi, S.3
  • 13
    • 0029001313 scopus 로고
    • An extension of the continual reassessment methods using a preliminary up-and-down design in a dose finding study in cancer patients in order to investigate a greater range of doses
    • Møller S. An extension of the continual reassessment methods using a preliminary up-and-down design in a dose finding study in cancer patients in order to investigate a greater range of doses. Stat. Med. (1995) 14 911-922.
    • (1995) Stat. Med. , vol.14 , pp. 911-922
    • Møller, S.1
  • 14
    • 0029938415 scopus 로고    scopus 로고
    • Continual reassessment method: A likelihood approach
    • O'Quigley J., Shen L.Z. Continual reassessment method: a likelihood approach. Biometrics (1996) 52 673-684.
    • (1996) Biometrics , vol.52 , pp. 673-684
    • O'Quigley, J.1    Shen, L.Z.2
  • 15
    • 0033918775 scopus 로고    scopus 로고
    • A curve-free method for phase I clinical trials
    • Gasparini M., Eisele J. A curve-free method for phase I clinical trials. Biometrics (2000) 56 609-615.
    • (2000) Biometrics , vol.56 , pp. 609-615
    • Gasparini, M.1    Eisele, J.2
  • 16
    • 0036185781 scopus 로고    scopus 로고
    • Curve-free and model-based continual reassessment method designs
    • O'Quigley J. Curve-free and model-based continual reassessment method designs. Biometrics (2002) 58 245-249.
    • (2002) Biometrics , vol.58 , pp. 245-249
    • O'Quigley, J.1
  • 17
    • 0000589197 scopus 로고    scopus 로고
    • A stopping rule for the continual reassessment method
    • O'Quigley J., Reiner E. A stopping rule for the continual reassessment method, Biometrika (1998) 85 741-748.
    • (1998) Biometrika , vol.85 , pp. 741-748
    • O'Quigley, J.1    Reiner, E.2
  • 18
    • 0033564086 scopus 로고    scopus 로고
    • Adaptive design improvements in the continual reassessment method for phase I studies
    • Heyd J.M., Carlin B.P. Adaptive design improvements in the continual reassessment method for phase I studies. Stat. Med. (1999) 18 1307-1321.
    • (1999) Stat. Med. , vol.18 , pp. 1307-1321
    • Heyd, J.M.1    Carlin, B.P.2
  • 19
    • 0035888182 scopus 로고    scopus 로고
    • The continual reassessment method: Comparison of Bayesian stopping rules for dose-ranging studies
    • Zohar S., Chevret S. The continual reassessment method: comparison of Bayesian stopping rules for dose-ranging studies. Stat. Med. (2001) 20 2827-2843.
    • (2001) Stat. Med. , vol.20 , pp. 2827-2843
    • Zohar, S.1    Chevret, S.2
  • 20
    • 0032581450 scopus 로고    scopus 로고
    • An evaluation of phase I cancer clinical trial design
    • Ahn C. An evaluation of phase I cancer clinical trial design. Stat. Med. (1998) 17 1537-1549.
    • (1998) Stat. Med. , vol.17 , pp. 1537-1549
    • Ahn, C.1
  • 21
    • 0030848713 scopus 로고    scopus 로고
    • Bayesian decision procedures with application to dose-finding studies
    • Whitehead J. Bayesian decision procedures with application to dose-finding studies. Int. J. Pharm. Med. (1997) 11 201-208.
    • (1997) Int. J. Pharm. Med. , vol.11 , pp. 201-208
    • Whitehead, J.1
  • 22
    • 0031670630 scopus 로고    scopus 로고
    • An evaluation of Bayesian decision procedures for dose-finding studies
    • Whitehead J., Williamson D. An evaluation of Bayesian decision procedures for dose-finding studies. J. Biopharm. Med. (1998) 8 445-467.
    • (1998) J. Biopharm. Med. , vol.8 , pp. 445-467
    • Whitehead, J.1    Williamson, D.2
  • 23
    • 0033883272 scopus 로고    scopus 로고
    • A two-stage dose selection strategy in phase I trials with wide dose ranges
    • Wang O., Faries D.E. A two-stage dose selection strategy in phase I trials with wide dose ranges. J. Biopharm. Stat. (2000) 10 319-333.
    • (2000) J. Biopharm. Stat. , vol.10 , pp. 319-333
    • Wang, O.1    Faries, D.E.2
  • 24
    • 0142153227 scopus 로고    scopus 로고
    • Practical implementation of Bayesian dose-escalation procedures
    • Zhou Y., Whitehead J. Practical implementation of Bayesian dose-escalation procedures. Drug Inform. J. (2003) 37 45-59.
    • (2003) Drug Inform. J. , vol.37 , pp. 45-59
    • Zhou, Y.1    Whitehead, J.2
  • 26
    • 0031920799 scopus 로고    scopus 로고
    • Cancer phase I clinical trials: Efficient dose escalation with overdose control
    • Babb J., Rogatko A., Zacks S. Cancer phase I clinical trials: efficient dose escalation with overdose control. Stat. Med. (1998) 17 1103-1120.
    • (1998) Stat. Med. , vol.17 , pp. 1103-1120
    • Babb, J.1    Rogatko, A.2    Zacks, S.3
  • 27
    • 84947406205 scopus 로고
    • A method for obtaining an analysing sensitivity data
    • Dixon W.J., Mood A.M. A method for obtaining an analysing sensitivity data. J. Am. Stat. Assoc. (1948) 43 109-126.
    • (1948) J. Am. Stat. Assoc. , vol.43 , pp. 109-126
    • Dixon, W.J.1    Mood, A.M.2
  • 28
    • 0024452804 scopus 로고
    • Design and analysis of phase I clinical trials
    • Storer B.E. Design and analysis of phase I clinical trials. Biometrics (1989) 45 925-937.
    • (1989) Biometrics , vol.45 , pp. 925-937
    • Storer, B.E.1
  • 29
    • 0030993031 scopus 로고    scopus 로고
    • A random walk rule for phase I clinical trials
    • Durham S.D., Flournoy N., Rosenberger W.F. A random walk rule for phase I clinical trials. Biometrics (1997) 53 745-760.
    • (1997) Biometrics , vol.53 , pp. 745-760
    • Durham, S.D.1    Flournoy, N.2    Rosenberger, W.F.3
  • 30
    • 0035075179 scopus 로고    scopus 로고
    • Isotonic designs for phase I trials
    • Leung D.H., Wang Y. Isotonic designs for phase I trials. Control. Clin. Trials (2001) 22 126-138.
    • (2001) Control. Clin. Trials , vol.22 , pp. 126-138
    • Leung, D.H.1    Wang, Y.2
  • 32
    • 0002434647 scopus 로고    scopus 로고
    • Easy-to-implement Bayesian methods for dose-escalation studies in healthy volunteers
    • Whitehead J., Zhou Y., Patterson S., Webber D., Francis S. Easy-to-implement Bayesian methods for dose-escalation studies in healthy volunteers. Biostatistics (2001) 2 47-61.
    • (2001) Biostatistics , vol.2 , pp. 47-61
    • Whitehead, J.1    Zhou, Y.2    Patterson, S.3    Webber, D.4    Francis, S.5
  • 33
    • 0027949027 scopus 로고
    • Simulation as a design tool for phase I/II clinical trials: An example from bone-marrow transplantation
    • Gooley T.A., Martin P.J. Simulation as a design tool for phase I/II clinical trials: an example from bone-marrow transplantation. Control. Clin. Trials (1994) 15 450-462.
    • (1994) Control. Clin. Trials , vol.15 , pp. 450-462
    • Gooley, T.A.1    Martin, P.J.2
  • 34
    • 0031953966 scopus 로고    scopus 로고
    • A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials
    • Thall P.F., Russell K.E. A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics (1998) 54 251-264.
    • (1998) Biometrics , vol.54 , pp. 251-264
    • Thall, P.F.1    Russell, K.E.2
  • 35
    • 0035186085 scopus 로고    scopus 로고
    • Dose-finding designs for HIV studies
    • O'Quigley J., Hughes M.D., Fenton T. Dose-finding designs for HIV studies. Biometrics (2001) 57 1018-1029.
    • (2001) Biometrics , vol.57 , pp. 1018-1029
    • O'Quigley, J.1    Hughes, M.D.2    Fenton, T.3
  • 36
    • 0036277621 scopus 로고    scopus 로고
    • The bivariate continual reassessment method: Extending the CRM to phase I trials of two competing outcomes
    • Braun T.M. The bivariate continual reassessment method: extending the CRM to phase I trials of two competing outcomes. Control. Clin. Trials (2002) 23 240-256.
    • (2002) Control. Clin. Trials , vol.23 , pp. 240-256
    • Braun, T.M.1
  • 37
    • 0029033654 scopus 로고
    • Influence of confounding factors on designs for dose-effect relationship estimates
    • Girard P., Laporte-Simitsidis S., Mismetti P., Decousus H. Influence of confounding factors on designs for dose-effect relationship estimates. Stat. Med. (1995) 14 987-1005.
    • (1995) Stat. Med. , vol.14 , pp. 987-1005
    • Girard, P.1    Laporte-Simitsidis, S.2    Mismetti, P.3    Decousus, H.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.