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Volumn 26, Issue 3, 2008, Pages 300-307

Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer

Author keywords

Binary endpoint; Phase III trials; Prostate cancer; Sample size; Survival endpoint

Indexed keywords

ANALYTICAL ERROR; CANCER SURVIVAL; DATA ANALYSIS; HUMAN; HYPOTHESIS; KAPLAN MEIER METHOD; MASKING; METHODOLOGY; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROPORTIONAL HAZARDS MODEL; PROSTATE CANCER; RANDOM SAMPLE; RANDOMIZATION; REVIEW; SAMPLE SIZE; STATISTICAL ANALYSIS; SURVIVAL RATE; SURVIVAL TIME;

EID: 42949119320     PISSN: 10781439     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.urolonc.2006.11.007     Document Type: Review
Times cited : (3)

References (40)
  • 3
    • 0029808474 scopus 로고    scopus 로고
    • Clinical trials in relapsed prostate cancer: Defining the target
    • Scher H.I., Mazumdar M., and Kelly W.K. Clinical trials in relapsed prostate cancer: Defining the target. J Natl Cancer Inst 88 (1996) 1623-1634
    • (1996) J Natl Cancer Inst , vol.88 , pp. 1623-1634
    • Scher, H.I.1    Mazumdar, M.2    Kelly, W.K.3
  • 4
    • 4143086197 scopus 로고    scopus 로고
    • Impact of race on survival in men with metastatic hormone refractory prostate cancer
    • Halabi S., Small E.J., Vogelzang N.J., et al. Impact of race on survival in men with metastatic hormone refractory prostate cancer. Urology 64 (2004) 212-217
    • (2004) Urology , vol.64 , pp. 212-217
    • Halabi, S.1    Small, E.J.2    Vogelzang, N.J.3
  • 5
    • 1442290324 scopus 로고    scopus 로고
    • Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising PSA: Recommendations from the prostate-specific antigen working group
    • Scher H.I., Eisenberger M., D'Amico A.V., et al. Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising PSA: Recommendations from the prostate-specific antigen working group. J Clin Oncol 22 (2004) 537-556
    • (2004) J Clin Oncol , vol.22 , pp. 537-556
    • Scher, H.I.1    Eisenberger, M.2    D'Amico, A.V.3
  • 6
    • 4744337716 scopus 로고    scopus 로고
    • Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer
    • Petrylak D.P., Tangen C.M., Hussain M.H.A., et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351 (2004) 1513-1520
    • (2004) N Engl J Med , vol.351 , pp. 1513-1520
    • Petrylak, D.P.1    Tangen, C.M.2    Hussain, M.H.A.3
  • 7
    • 0002428299 scopus 로고
    • Design and conduct of clinical trials
    • DeVita V.T., Hellman S., and Rosenberg S.A. (Eds), Lippincott, Philadelphia (PA)
    • Simon R.S. Design and conduct of clinical trials. In: DeVita V.T., Hellman S., and Rosenberg S.A. (Eds). Cancer: Principles and practice of oncology (1993), Lippincott, Philadelphia (PA) 418-440
    • (1993) Cancer: Principles and practice of oncology , pp. 418-440
    • Simon, R.S.1
  • 8
    • 0013311859 scopus 로고
    • The design and analysis of equivalence trials
    • Finkelstein D.M., and Schoenfeld D.A. (Eds), Wiley-Liss, Inc, New York (NY)
    • Amato D.A. The design and analysis of equivalence trials. In: Finkelstein D.M., and Schoenfeld D.A. (Eds). AIDS clinical trials (1995), Wiley-Liss, Inc, New York (NY) 155-176
    • (1995) AIDS clinical trials , pp. 155-176
    • Amato, D.A.1
  • 9
    • 0032784113 scopus 로고    scopus 로고
    • Hydrocortisone with or without mitoxantrone in men with hormone refractory prostate cancer: The results of CALGB 9182
    • Kantoff P.W., Halabi S., Conaway M., et al. Hydrocortisone with or without mitoxantrone in men with hormone refractory prostate cancer: The results of CALGB 9182. J Clin Oncol 17 (1999) 2506-2513
    • (1999) J Clin Oncol , vol.17 , pp. 2506-2513
    • Kantoff, P.W.1    Halabi, S.2    Conaway, M.3
  • 10
    • 0032550753 scopus 로고    scopus 로고
    • A preoperative nomogram for disease recurrence following radical prostatectomy for prostate cancer
    • Kattan M.W., Eastham J.A., Stapleton A.M., et al. A preoperative nomogram for disease recurrence following radical prostatectomy for prostate cancer. J Natl Cancer Inst 90 (1998) 766-771
    • (1998) J Natl Cancer Inst , vol.90 , pp. 766-771
    • Kattan, M.W.1    Eastham, J.A.2    Stapleton, A.M.3
  • 11
    • 0037986306 scopus 로고    scopus 로고
    • Endpoints and United States Food and Drug Administration approval of oncology drugs
    • Johnson J.R., Williams G., and Pazdur R. Endpoints and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 7 (2003) 1404-1411
    • (2003) J Clin Oncol , vol.7 , pp. 1404-1411
    • Johnson, J.R.1    Williams, G.2    Pazdur, R.3
  • 12
    • 6944247669 scopus 로고    scopus 로고
    • Accelerated approval of oncology products: A decade of experience
    • Dagher R., Johnson J., Williams G., et al. Accelerated approval of oncology products: A decade of experience. J Natl Cancer Inst 96 (2004) 1500-1509
    • (2004) J Natl Cancer Inst , vol.96 , pp. 1500-1509
    • Dagher, R.1    Johnson, J.2    Williams, G.3
  • 13
    • 0029311320 scopus 로고
    • Design of the Prostate Cancer Prevention Trial (PCPT)
    • Feigl P., Blumenstein B., Thompson I., et al. Design of the Prostate Cancer Prevention Trial (PCPT). Control Clin Trials 16 (1995) 150-163
    • (1995) Control Clin Trials , vol.16 , pp. 150-163
    • Feigl, P.1    Blumenstein, B.2    Thompson, I.3
  • 14
    • 0345868342 scopus 로고    scopus 로고
    • Statistical design issues and other practical considerations for conducting phase III prostate cancer prevention trials
    • Tangen C.T., Goodman P.J., Crowley J.J., et al. Statistical design issues and other practical considerations for conducting phase III prostate cancer prevention trials. J Urol 171 (2004) S64-S67
    • (2004) J Urol , vol.171
    • Tangen, C.T.1    Goodman, P.J.2    Crowley, J.J.3
  • 15
    • 0037102220 scopus 로고    scopus 로고
    • A randomized study of three different doses of suramin administered with a fixed dosing schedule in patients with advanced prostate cancer: Results of intergroup 0159 (CALGB 9480)
    • Small E.J., Halabi S., Ratain M.J., et al. A randomized study of three different doses of suramin administered with a fixed dosing schedule in patients with advanced prostate cancer: Results of intergroup 0159 (CALGB 9480). J Clin Oncol 20 (2002) 3369-3375
    • (2002) J Clin Oncol , vol.20 , pp. 3369-3375
    • Small, E.J.1    Halabi, S.2    Ratain, M.J.3
  • 16
    • 1842457650 scopus 로고    scopus 로고
    • A phase III trial of antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: Results of CALGB 9583
    • Small E.J., Halabi S., Dawson N., et al. A phase III trial of antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: Results of CALGB 9583. J Clin Oncol 22 (2004) 1025-1033
    • (2004) J Clin Oncol , vol.22 , pp. 1025-1033
    • Small, E.J.1    Halabi, S.2    Dawson, N.3
  • 17
    • 0033669409 scopus 로고    scopus 로고
    • Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer
    • Wei J.T., Dunn R.L., Litwin M.S., et al. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology 56 (2000) 899-905
    • (2000) Urology , vol.56 , pp. 899-905
    • Wei, J.T.1    Dunn, R.L.2    Litwin, M.S.3
  • 18
    • 7644240078 scopus 로고    scopus 로고
    • Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma
    • Ahles T.A., Herndon II J.E., Small E.J., et al. Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma. Cancer 101 (2004) 2202-2208
    • (2004) Cancer , vol.101 , pp. 2202-2208
    • Ahles, T.A.1    Herndon II, J.E.2    Small, E.J.3
  • 19
    • 0018346971 scopus 로고
    • Allocation of patients in clinical trials
    • Pocock S.J. Allocation of patients in clinical trials. Biometrics 35 (1979) 183-197
    • (1979) Biometrics , vol.35 , pp. 183-197
    • Pocock, S.J.1
  • 20
    • 0017042882 scopus 로고
    • Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design
    • Peto R., Pike M.C., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 34 (1976) 585-612
    • (1976) Br J Cancer , vol.34 , pp. 585-612
    • Peto, R.1    Pike, M.C.2    Armitage, P.3
  • 21
    • 0038514138 scopus 로고    scopus 로고
    • A prognostic model for predicting overall survival in men with advanced prostate cancer
    • Halabi S., Small E.J., Kantoff P.W., et al. A prognostic model for predicting overall survival in men with advanced prostate cancer. J Clin Oncol 21 (2003) 1232-1237
    • (2003) J Clin Oncol , vol.21 , pp. 1232-1237
    • Halabi, S.1    Small, E.J.2    Kantoff, P.W.3
  • 22
    • 0015949151 scopus 로고
    • Planning the size and duration of a clinical trial studying the time to some critical event
    • George S.L., and Desu M.M. Planning the size and duration of a clinical trial studying the time to some critical event. J Chronic Dis 27 (1974) 15-29
    • (1974) J Chronic Dis , vol.27 , pp. 15-29
    • George, S.L.1    Desu, M.M.2
  • 23
    • 0019383823 scopus 로고
    • Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation
    • Rubinstein L.V., Gail M.H., Santner T.J., et al. Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. J Chronic Dis 34 (1981) 469-479
    • (1981) J Chronic Dis , vol.34 , pp. 469-479
    • Rubinstein, L.V.1    Gail, M.H.2    Santner, T.J.3
  • 25
    • 0028017680 scopus 로고
    • Extension of one-sided test to multiple treatment trials
    • Chen T.T., and Simon R.M. Extension of one-sided test to multiple treatment trials. Control Clin Trials 15 (1994) 124-134
    • (1994) Control Clin Trials , vol.15 , pp. 124-134
    • Chen, T.T.1    Simon, R.M.2
  • 26
    • 2942648041 scopus 로고    scopus 로고
    • Sample size determination for comparing several survival curves with unequal allocations
    • Halabi S., and Singh B. Sample size determination for comparing several survival curves with unequal allocations. Stat Med 23 (2004) 1793-1815
    • (2004) Stat Med , vol.23 , pp. 1793-1815
    • Halabi, S.1    Singh, B.2
  • 27
    • 0027136747 scopus 로고
    • Sample size requirements and length of study for testing interaction in a 2 × k factorial design when time-to-failure is the outcome [corrected]
    • 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 [corrected]. Control Clin Trials 14 (1993) 511-522
    • (1993) Control Clin Trials , vol.14 , pp. 511-522
    • Peterson, B.1    George, S.L.2
  • 28
    • 0018077607 scopus 로고
    • An improved approximate formula for calculating sample sizes for comparing two binomial distributions
    • Casagrande J.T., Pike M.C., and Smith P.G. An improved approximate formula for calculating sample sizes for comparing two binomial distributions. Biometrics 34 (1978) 483-486
    • (1978) Biometrics , vol.34 , pp. 483-486
    • Casagrande, J.T.1    Pike, M.C.2    Smith, P.G.3
  • 29
    • 0009155205 scopus 로고
    • Repeated significance tests on accumulating data when the null hypothesis is not true
    • McPherson K., and Armitage P. Repeated significance tests on accumulating data when the null hypothesis is not true. J Royal Stat Soc A 134 (1971) 15-25
    • (1971) J Royal Stat Soc A , vol.134 , pp. 15-25
    • McPherson, K.1    Armitage, P.2
  • 30
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • O'Brien P.C., and Fleming T.R. A multiple testing procedure for clinical trials. Biometrics 35 (1979) 549-556
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 31
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan K.K.G., and DeMets D.L. Discrete sequential boundaries for clinical trials. Biometrika 70 (1983) 659-663
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    DeMets, D.L.2
  • 32
    • 0024427644 scopus 로고
    • Symmetric group sequential test designs
    • Emerson S., and Fleming T.R. Symmetric group sequential test designs. Biometrics 45 (1989) 905-923
    • (1989) Biometrics , vol.45 , pp. 905-923
    • Emerson, S.1    Fleming, T.R.2
  • 33
    • 0032863539 scopus 로고    scopus 로고
    • Data monitoring committees and interim monitoring guidelines
    • Freidlin B., Korn E., and George S. Data monitoring committees and interim monitoring guidelines. Control Clin Trials 20 (1999) 395-407
    • (1999) Control Clin Trials , vol.20 , pp. 395-407
    • Freidlin, B.1    Korn, E.2    George, S.3
  • 34
    • 33845382806 scopus 로고
    • Nonparametric estimation from incomplete observations
    • Kaplan E., and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958) 457-481
    • (1958) J Am Stat Assoc , vol.53 , pp. 457-481
    • Kaplan, E.1    Meier, P.2
  • 35
    • 0017365573 scopus 로고
    • Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Analysis and examples
    • Peto R., Pike M.C., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Analysis and examples. Br J Cancer 35 (1977) 1-39
    • (1977) Br J Cancer , vol.35 , pp. 1-39
    • Peto, R.1    Pike, M.C.2    Armitage, P.3
  • 36
    • 0000336139 scopus 로고
    • Regression models and life tables
    • Cox D.R. Regression models and life tables. J Royal Statistical Society B 34 (1972) 187-220
    • (1972) J Royal Statistical Society B , vol.34 , pp. 187-220
    • Cox, D.R.1
  • 37
    • 0020049956 scopus 로고
    • A plain man's guide to the proportional hazards model
    • Tibshirani R. A plain man's guide to the proportional hazards model. Clin Invest Med 5 (1982) 63-68
    • (1982) Clin Invest Med , vol.5 , pp. 63-68
    • Tibshirani, R.1
  • 38
  • 39
    • 0000120995 scopus 로고    scopus 로고
    • A class of k sample tests for comparing the cumulative incidence of a competing risk
    • Gray R.J. A class of k sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 16 (1999) 1141-1154
    • (1999) Ann Stat , vol.16 , pp. 1141-1154
    • Gray, R.J.1
  • 40
    • 0027166881 scopus 로고
    • Kaplan-Meier marginal or conditional probability curves in summarizing competing risks failure time data
    • Pepe M., and Mori M. Kaplan-Meier marginal or conditional probability curves in summarizing competing risks failure time data. Stat Med 12 (1993) 737-751
    • (1993) Stat Med , vol.12 , pp. 737-751
    • Pepe, M.1    Mori, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.