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Volumn 30, Issue 14, 2011, Pages 1637-1647

Maximum inflation of the type 1 error rate when sample size and allocation rate are adapted in a pre-planned interim look

Author keywords

Changing allocation rates; Conditional error function; Interim analysis; Maximum type 1 error rate; Sample size reassessment; Z test

Indexed keywords

ALLOCATION RATE; ARTICLE; CONTROL GROUP; MAXIMUM TYPE 1 ERROR RATE; NORMAL DISTRIBUTION; NULL HYPOTHESIS; OUTCOME VARIABLE; SAMPLE SIZE; SAMPLING; SAMPLING ERROR; STATISTICAL ANALYSIS;

EID: 79957950338     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.4230     Document Type: Article
Times cited : (14)

References (18)
  • 1
    • 0029589385 scopus 로고
    • Designed extension of studies based on conditional power
    • Proschan MA, Hunsberger SA. Designed extension of studies based on conditional power. Biometrics 1995; 51:1315-1324.
    • (1995) Biometrics , vol.51 , pp. 1315-1324
    • Proschan, M.A.1    Hunsberger, S.A.2
  • 3
    • 0028619850 scopus 로고
    • Evaluations of experiments with adaptive interim analysis
    • Bauer P, Koehne K. Evaluations of experiments with adaptive interim analysis. Biometrics 1994; 50:1029-1041.
    • (1994) Biometrics , vol.50 , pp. 1029-1041
    • Bauer, P.1    Koehne, K.2
  • 4
    • 0032732411 scopus 로고    scopus 로고
    • Adaptive sample size calculations in group sequential trials
    • Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials. Biometrics 1999; 55:1286-1290.
    • (1999) Biometrics , vol.55 , pp. 1286-1290
    • Lehmacher, W.1    Wassmer, G.2
  • 5
    • 0036489056 scopus 로고    scopus 로고
    • Recursive combination tests
    • Brannath W, Posch M, Bauer P. Recursive combination tests. JASA 2002; 97:236-244.
    • (2002) JASA , vol.97 , pp. 236-244
    • Brannath, W.1    Posch, M.2    Bauer, P.3
  • 6
    • 0034876356 scopus 로고    scopus 로고
    • Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and of classical group sequential approaches
    • Mueller HH, Schaefer H. Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and of classical group sequential approaches. Biometrics 2001; 95:886-891.
    • (2001) Biometrics , vol.95 , pp. 886-891
    • Mueller, H.H.1    Schaefer, H.2
  • 7
    • 4344665155 scopus 로고    scopus 로고
    • A general statistical principle for changing a design any time during the course of a trial
    • Mueller HH, Schaefer H. A general statistical principle for changing a design any time during the course of a trial. Statistics in Medicine 2004; 23:2497-2508.
    • (2004) Statistics in Medicine , vol.23 , pp. 2497-2508
    • Mueller, H.H.1    Schaefer, H.2
  • 8
    • 66349091397 scopus 로고    scopus 로고
    • Sample size re-estimation in clinical trials
    • Proschan MA. Sample size re-estimation in clinical trials. Biometrical Journal 2009; 51:348-357.
    • (2009) Biometrical Journal , vol.51 , pp. 348-357
    • Proschan, M.A.1
  • 9
    • 11844299859 scopus 로고    scopus 로고
    • Conditional rejection probabilities of students t-test and design adaptations
    • Posch M, Timmesfeld N, Koenig F, Mueller HH. Conditional rejection probabilities of students t-test and design adaptations. Biometrical Journal 2004; 46:389-403.
    • (2004) Biometrical Journal , vol.46 , pp. 389-403
    • Posch, M.1    Timmesfeld, N.2    Koenig, F.3    Mueller, H.H.4
  • 10
    • 34249038417 scopus 로고    scopus 로고
    • Increasing the sample size during clinical trials with t-distributed test statistics without inflating the type I error rate
    • Timmesfeld N, Schaefer H, Mueller HH. Increasing the sample size during clinical trials with t-distributed test statistics without inflating the type I error rate. Statistics in Medicine 2006; 26:2449-2464.
    • (2006) Statistics in Medicine , vol.26 , pp. 2449-2464
    • Timmesfeld, N.1    Schaefer, H.2    Mueller, H.H.3
  • 11
    • 85153179723 scopus 로고    scopus 로고
    • A general approach to the conditional error rate principle with nuisance parameters
    • DOI: 10.1111/j.1541.
    • Gutjahr G, Brannath W, Bauer P. A general approach to the conditional error rate principle with nuisance parameters. Biometrics 2010; DOI: 10.1111/j.1541.
    • (2010) Biometrics
    • Gutjahr, G.1    Brannath, W.2    Bauer, P.3
  • 12
    • 79957952447 scopus 로고    scopus 로고
    • Committee for Proprietary Medical Products (CPMP). Statistical principles for clinical trials. CPMP/ICH/ 363/96.
    • Committee for Proprietary Medical Products (CPMP). Statistical principles for clinical trials. 1998; CPMP/ICH/ 363/96.
    • (1998)
  • 13
    • 79957937536 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP). Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. CHMP/EWP/2459/02.
    • Committee for Medicinal Products for Human Use (CHMP). Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. 2007; CHMP/EWP/2459/02.
    • (2007)
  • 14
    • 65649112030 scopus 로고    scopus 로고
    • Exploring changes in treatment effects across design stages in adaptive trials
    • Friede T, Henderson R. Exploring changes in treatment effects across design stages in adaptive trials. Pharmaceutical Statistics 2009; 8:62-72.
    • (2009) Pharmaceutical Statistics , vol.8 , pp. 62-72
    • Friede, T.1    Henderson, R.2
  • 16
    • 66349086534 scopus 로고    scopus 로고
    • Challenges and regulatory experiences in non-inferiority trial design without placebo arm
    • Hung HM, Wang SJ, O'Neill RT. Challenges and regulatory experiences in non-inferiority trial design without placebo arm. Biometrical Journal 2009; 51:324-334.
    • (2009) Biometrical Journal , vol.51 , pp. 324-334
    • Hung, H.M.1    Wang, S.J.2    O'Neill, R.T.3
  • 18
    • 77950912779 scopus 로고    scopus 로고
    • A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information
    • Stallard N. A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information. Statistics in Medicine 2009; 29:959-971.
    • (2009) Statistics in Medicine , vol.29 , pp. 959-971
    • Stallard, N.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.