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Volumn 33, Issue 22, 2014, Pages 3830-3843

One-stage and two-stage designs for phase II clinical trials with survival endpoints

Author keywords

Cancer trial; Phase II trial; Sample size calculation; Survival data; Two stage designs

Indexed keywords

ANTINEOPLASTIC AGENT;

EID: 84906822793     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.6196     Document Type: Article
Times cited : (13)

References (21)
  • 1
    • 84954594013 scopus 로고    scopus 로고
    • Phase II clinical trials
    • Biswas A, Datta S, Fine M, Segal MR (eds). Wiley-Interscience: Hoboken, N. J.
    • Stallard N. Phase II clinical trials. In Statistical Advances in the Biomedical Sciences, Biswas A, Datta S, Fine M, Segal MR (eds). Wiley-Interscience: Hoboken, N. J., 2008; 15-32.
    • (2008) Statistical Advances in the Biomedical Sciences , pp. 15-32
    • Stallard, N.1
  • 2
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • Simon R. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989; 10: 1-10.
    • (1989) Controlled Clinical Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 3
    • 1842294029 scopus 로고    scopus 로고
    • Optimal three-stage designs for phase II cancer clinical trials
    • Chen TT. Optimal three-stage designs for phase II cancer clinical trials. Statistics in Medicine 1997; 16: 2701-2711.
    • (1997) Statistics in Medicine , vol.16 , pp. 2701-2711
    • Chen, T.T.1
  • 4
    • 0020108590 scopus 로고
    • One-sample multiple testing procedure for phase II clinical trials
    • Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143-151.
    • (1982) Biometrics , vol.38 , pp. 143-151
    • Fleming, T.R.1
  • 5
    • 0025127152 scopus 로고
    • Application of the triangular test to phase II cancer clinical trials
    • Bellisant E, Benichou J, Chastang C. Application of the triangular test to phase II cancer clinical trials. Statistics in Medicine 1990; 9: 907-917.
    • (1990) Statistics in Medicine , vol.9 , pp. 907-917
    • Bellisant, E.1    Benichou, J.2    Chastang, C.3
  • 6
    • 0009993920 scopus 로고    scopus 로고
    • Optimal two-stage designs for phase II clinical trials with differentiation of complete and partial responses
    • Lin SP, Chen TT. Optimal two-stage designs for phase II clinical trials with differentiation of complete and partial responses. Communications in Statistics - Theory and Methods 2000; 29: 923-940.
    • (2000) Communications in Statistics - Theory and Methods , vol.29 , pp. 923-940
    • Lin, S.P.1    Chen, T.T.2
  • 7
    • 50549174560 scopus 로고
    • The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent
    • Gehan EA. The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. Journal of Chronic Diseases 1961; 13: 346-353.
    • (1961) Journal of Chronic Diseases , vol.13 , pp. 346-353
    • Gehan, E.A.1
  • 8
    • 3042809745 scopus 로고    scopus 로고
    • Design of phase II cancer trials evaluating survival probabilities
    • Case LD, Morgan TM. Design of phase II cancer trials evaluating survival probabilities. BMC Medical Research Methodology 2003; 3: 6.
    • (2003) BMC Medical Research Methodology , vol.3 , pp. 6
    • Case, L.D.1    Morgan, T.M.2
  • 9
    • 54549105379 scopus 로고    scopus 로고
    • Designing phase II studies in cancer with time-to-event endpoints
    • Owzar K, Jung SH. Designing phase II studies in cancer with time-to-event endpoints. Clinical Trials 2008; 5: 209-221.
    • (2008) Clinical Trials , vol.5 , pp. 209-221
    • Owzar, K.1    Jung, S.H.2
  • 10
    • 78649906459 scopus 로고    scopus 로고
    • Phase II cancer clinical trials with a one-sample log-rank test and its corrections based on the Edgeworth expansion
    • Sun X, Peng P, Tu D. Phase II cancer clinical trials with a one-sample log-rank test and its corrections based on the Edgeworth expansion. Contemporary Clinical Trials 2011; 32: 108-113.
    • (2011) Contemporary Clinical Trials , vol.32 , pp. 108-113
    • Sun, X.1    Peng, P.2    Tu, D.3
  • 11
    • 0001152986 scopus 로고
    • Rank tests and a one-sample log rank test for comparing observed survival data to a standard population
    • Woolson RF. Rank tests and a one-sample log rank test for comparing observed survival data to a standard population. Biometrics 1981; 37: 687-696.
    • (1981) Biometrics , vol.37 , pp. 687-696
    • Woolson, R.F.1
  • 12
    • 30444432951 scopus 로고    scopus 로고
    • Monitoring event times in early phase clinical trials: some practical issues
    • Thall PF, Wooten LH, Tanir NM. Monitoring event times in early phase clinical trials: some practical issues. Clinical Trials 2005; 2: 467-478.
    • (2005) Clinical Trials , vol.2 , pp. 467-478
    • Thall, P.F.1    Wooten, L.H.2    Tanir, N.M.3
  • 13
    • 84863994177 scopus 로고    scopus 로고
    • Bayesian decision theoretic two-stage design in phase II clinical trials with survival endpoint
    • Zhao L, Taylor JMG, Schuetze SM. Bayesian decision theoretic two-stage design in phase II clinical trials with survival endpoint. Statistics in Medicine 2012; 31: 1804-1820.
    • (2012) Statistics in Medicine , vol.31 , pp. 1804-1820
    • Zhao, L.1    Taylor, J.M.G.2    Schuetze, S.M.3
  • 15
    • 0001072895 scopus 로고
    • The use of confidence or fiducial limits illustrated in the case of the binomial
    • Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934; 26: 404-413.
    • (1934) Biometrika , vol.26 , pp. 404-413
    • Clopper, C.J.1    Pearson, E.S.2
  • 16
    • 78650239326 scopus 로고    scopus 로고
    • An exact method for analysis following a two-stage phase II cancer clinical trial
    • Jovic G, Whitehead J. An exact method for analysis following a two-stage phase II cancer clinical trial. Statistics in Medicine 2010; 29: 3118-3125.
    • (2010) Statistics in Medicine , vol.29 , pp. 3118-3125
    • Jovic, G.1    Whitehead, J.2
  • 17
    • 0029795144 scopus 로고    scopus 로고
    • Group sequential designs for monitoring survival probabilities
    • Lin DY, Shen L, Ying Z, Breslow NE. Group sequential designs for monitoring survival probabilities. Biometrics 1996; 52: 1033-1042.
    • (1996) Biometrics , vol.52 , pp. 1033-1042
    • Lin, D.Y.1    Shen, L.2    Ying, Z.3    Breslow, N.E.4
  • 18
    • 79960951145 scopus 로고    scopus 로고
    • Group sequential trials revisited: simple implementation using SAS
    • Whitehead J. Group sequential trials revisited: simple implementation using SAS. Statistical Methods in Medical Research 2011; 20: 636-656.
    • (2011) Statistical Methods in Medical Research , vol.20 , pp. 636-656
    • Whitehead, J.1
  • 20
    • 44949170805 scopus 로고    scopus 로고
    • Bayesian sample size for exploratory clinical trials incorporating historical data
    • Whitehead J, Valdés-Márquez E, Johnson P, Graham G. Bayesian sample size for exploratory clinical trials incorporating historical data. Statistics in Medicine 2008; 27: 2307-2327.
    • (2008) Statistics in Medicine , vol.27 , pp. 2307-2327
    • Whitehead, J.1    Valdés-Márquez, E.2    Johnson, P.3    Graham, G.4
  • 21
    • 84906835726 scopus 로고    scopus 로고
    • A Bayesian method for setting sample sizes and choosing allocation ratios in phase II clinical trials with exponential and Weibull distributed time-to-event endpoints. In preparation.
    • Cotterill A, Whitehead J. A Bayesian method for setting sample sizes and choosing allocation ratios in phase II clinical trials with exponential and Weibull distributed time-to-event endpoints. In preparation.
    • Cotterill, A.1    Whitehead, J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.