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Volumn 27, Issue 26, 2008, Pages 5377-5391

An efficient method for accommodating potentially underpowered primary endpoints

Author keywords

Adaptive alpha allocation; Clinical trials; Multiple primary endpoints

Indexed keywords

ARTICLE; BIOASSAY; CLINICAL TRIAL; COMPUTER SIMULATION; HUMAN; METHODOLOGY; STATISTICAL ANALYSIS;

EID: 54549086549     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3369     Document Type: Article
Times cited : (41)

References (23)
  • 1
    • 0033011501 scopus 로고    scopus 로고
    • Carvedilol and the food and drug administration approval process: an introduction.
    • Fisher LD, Moyé LA. Carvedilol and the food and drug administration approval process: an introduction. Controlled Clinical Trials 1999; 20:1-15.
    • (1999) Controlled Clinical Trials , vol.20 , pp. 1-15
    • Fisher, L.D.1    Moyé, L.A.2
  • 2
    • 0032971979 scopus 로고    scopus 로고
    • Carvedilol and FDA approval process: the FDA paradigm and reflection upon hypothesis testing.
    • Fisher L. Carvedilol and FDA approval process: the FDA paradigm and reflection upon hypothesis testing. Controlled Clinical Trials 1999; 20:16-39.
    • (1999) Controlled Clinical Trials , vol.20 , pp. 16-39
    • Fisher, L.1
  • 3
    • 0032972732 scopus 로고    scopus 로고
    • End-point interpretation in clinical trials: the case for discipline.
    • Moyé LA. End-point interpretation in clinical trials: the case for discipline. Controlled Clinical Trials 2000; 20:40-49.
    • (2000) Controlled Clinical Trials , vol.20 , pp. 40-49
    • Moyé, L.A.1
  • 4
    • 0030694389 scopus 로고    scopus 로고
    • Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance.
    • O'Neill RT. Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance. Controlled Clinical Trials 1997; 18:550-556.
    • (1997) Controlled Clinical Trials , vol.18 , pp. 550-556
    • O'Neill, R.T.1
  • 5
    • 0030670880 scopus 로고    scopus 로고
    • Secondary endpoints can be validly analyzed, even if the primary endpoint does not provide clear statistical significance.
    • Davis CE. Secondary endpoints can be validly analyzed, even if the primary endpoint does not provide clear statistical significance. Controlled Clinical Trials 1997; 18:557-560.
    • (1997) Controlled Clinical Trials , vol.18 , pp. 557-560
    • Davis, C.E.1
  • 6
    • 0030670454 scopus 로고    scopus 로고
    • On the role and analysis of secondary outcomes in clinical trials.
    • Prentice RL. On the role and analysis of secondary outcomes in clinical trials. Controlled Clinical Trials 1997; 18:561-567.
    • (1997) Controlled Clinical Trials , vol.18 , pp. 561-567
    • Prentice, R.L.1
  • 7
    • 0034732220 scopus 로고    scopus 로고
    • Controlling alpha in a clinical trial: the case for secondary endpoints.
    • D'Agostino Sr RB. Controlling alpha in a clinical trial: the case for secondary endpoints. Statistics in Medicine 2000; 19:763-766.
    • (2000) Statistics in Medicine , vol.19 , pp. 763-766
    • D'Agostino Sr., R.B.1
  • 8
    • 0343673950 scopus 로고    scopus 로고
    • Alpha calculus in clinical trials: considerations and commentary for the new millennium.
    • Moye LA. Alpha calculus in clinical trials: considerations and commentary for the new millennium. Statistics in Medicine 2000; 19:767-779.
    • (2000) Statistics in Medicine , vol.19 , pp. 767-779
    • Moye, L.A.1
  • 9
    • 0034731878 scopus 로고    scopus 로고
    • Discussion for 'Alpha calculation in clinical trials: consideration and commentary for the new millennium'.
    • Koch GG. Discussion for 'Alpha calculation in clinical trials: consideration and commentary for the new millennium'. Statistics in Medicine 2000; 19:781-784.
    • (2000) Statistics in Medicine , vol.19 , pp. 781-784
    • Koch, G.G.1
  • 10
    • 0034731876 scopus 로고    scopus 로고
    • Commentary on 'Alpha calculation in clinical trials: consideration and commentary for the new millennium'.
    • O'Neill RT. Commentary on 'Alpha calculation in clinical trials: consideration and commentary for the new millennium'. Statistics in Medicine 2000; 19:785-793.
    • (2000) Statistics in Medicine , vol.19 , pp. 785-793
    • O'Neill, R.T.1
  • 11
    • 33744757187 scopus 로고    scopus 로고
    • Response to commentaries on 'Alpha calculus in clinical trials: considerations'.
    • Moye LA. Response to commentaries on 'Alpha calculus in clinical trials: considerations'. Statistics in Medicine 2000; 19:795-799.
    • (2000) Statistics in Medicine , vol.19 , pp. 795-799
    • Moye, L.A.1
  • 12
    • 33645762226 scopus 로고
    • A sharper Bonferroni procedure for multiple tests of significance.
    • Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988; 75:800-803.
    • (1988) Biometrika , vol.75 , pp. 800-803
    • Hochberg, Y.1
  • 13
    • 0001669952 scopus 로고
    • A stagewise rejective multiple test procedure based on a modified Bonferroni test.
    • Hommel G. A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika 1988; 75:383-386.
    • (1988) Biometrika , vol.75 , pp. 383-386
    • Hommel, G.1
  • 14
    • 15944368765 scopus 로고    scopus 로고
    • A fixed sequence Bonferroni procedure for testing multiple endpoints.
    • Wiens B. A fixed sequence Bonferroni procedure for testing multiple endpoints. Pharmaceutical Statistics 2003; 2:211-215.
    • (2003) Pharmaceutical Statistics , vol.2 , pp. 211-215
    • Wiens, B.1
  • 15
    • 27544506961 scopus 로고    scopus 로고
    • The fallback procedure for evaluating a single family of hypotheses.
    • Wiens B, Dmitrienko A. The fallback procedure for evaluating a single family of hypotheses. Journal of Pharmaceutical Statistics 2005; 15:1-14.
    • (2005) Journal of Pharmaceutical Statistics , vol.15 , pp. 1-14
    • Wiens, B.1    Dmitrienko, A.2
  • 16
    • 33745719308 scopus 로고    scopus 로고
    • A comparison of eight methods for the dual-endpoint evaluation of efficacy in a proof-of-concept HIV vaccine trial.
    • Mehrotra D, Li X, Gilbert P. A comparison of eight methods for the dual-endpoint evaluation of efficacy in a proof-of-concept HIV vaccine trial. Biometrics 2006; 62:893-900.
    • (2006) Biometrics , vol.62 , pp. 893-900
    • Mehrotra, D.1    Li, X.2    Gilbert, P.3
  • 17
    • 0030950122 scopus 로고    scopus 로고
    • The behavior of the p-value when the alternative hypothesis is true.
    • Hung HM, O'Neill R, Bauer P, Kohne K. The behavior of the p-value when the alternative hypothesis is true. Biometrics 1997; 53:11-22.
    • (1997) Biometrics , vol.53 , pp. 11-22
    • Hung, H.M.1    O'Neill, R.2    Bauer, P.3    Kohne, K.4
  • 18
    • 0141617402 scopus 로고    scopus 로고
    • Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues.
    • Sankoh AJ, D'Agostino RB, Huque MF. Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues. Statistics in Medicine 2003; 22:3133-3150.
    • (2003) Statistics in Medicine , vol.22 , pp. 3133-3150
    • Sankoh, A.J.1    D'Agostino, R.B.2    Huque, M.F.3
  • 19
    • 0033534085 scopus 로고    scopus 로고
    • Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure.
    • Packer M, Poole-Wilson PA, Armstrong PW, Cleland JG, Horowitz JD, Massie BM, Ryden L, Thygesen K, Uretsky BF. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. Circulation 1999; 100:2312-2318.
    • (1999) Circulation , vol.100 , pp. 2312-2318
    • Packer, M.1    Poole-Wilson, P.A.2    Armstrong, P.W.3    Cleland, J.G.4    Horowitz, J.D.5    Massie, B.M.6    Ryden, L.7    Thygesen, K.8    Uretsky, B.F.9
  • 23
    • 0023598472 scopus 로고
    • The analysis of multiple endpoints in clinical trials.
    • Pocock SJ, Geller NL, Tsiatis AA. The analysis of multiple endpoints in clinical trials. Biometrics 1987; 43:487-498.
    • (1987) Biometrics , vol.43 , pp. 487-498
    • Pocock, S.J.1    Geller, N.L.2    Tsiatis, A.A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.