메뉴 건너뛰기




Volumn 34, Issue 8, 2015, Pages 1317-1333

Adaptive seamless designs with interim treatment selection: A case study in oncology

Author keywords

Adaptive seamless designs; Confidence intervals; Family wise error rate; Selection bias; Surrogate endpoints; Treatment selection

Indexed keywords

ANALYTICAL ERROR; ARTICLE; BREAST METASTASIS; CASE STUDY; COMPUTER SIMULATION; DATA ANALYSIS; DRUG EFFICACY; DRUG SAFETY; HYPOTHESIS; INFORMATION PROCESSING; MEDICAL DECISION MAKING; METHODOLOGY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROPORTIONAL HAZARDS MODEL; QUALITY CONTROL; RISK BENEFIT ANALYSIS; SAMPLE SIZE; STOMACH CANCER; SYSTEMATIC ERROR; TREATMENT OUTCOME; TREATMENT PLANNING; BIOASSAY; DOSE RESPONSE; DRUG DESIGN; HUMAN; METASTASIS; PATHOLOGY; PROCEDURES; STATISTICAL ANALYSIS; STATISTICAL BIAS; STATISTICS AND NUMERICAL DATA; STOMACH NEOPLASMS; SURVIVAL;

EID: 84924436823     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.6407     Document Type: Article
Times cited : (13)

References (28)
  • 1
    • 1842736272 scopus 로고    scopus 로고
    • The advantages and disadvantages of adaptive designs for clinical trials
    • Bauer P, Brannath W. The advantages and disadvantages of adaptive designs for clinical trials. Drug Discovery Today 2004; 9:351-357.
    • (2004) Drug Discovery Today , vol.9 , pp. 351-357
    • Bauer, P.1    Brannath, W.2
  • 3
    • 0033618626 scopus 로고    scopus 로고
    • Combining different phases in the development of medical treatments within a single trial
    • Bauer P, Kieser M. Combining different phases in the development of medical treatments within a single trial. Statistics in Medicine 1999; 18:1833-1848.
    • (1999) Statistics in Medicine , vol.18 , pp. 1833-1848
    • Bauer, P.1    Kieser, M.2
  • 4
    • 0040374501 scopus 로고    scopus 로고
    • Adaptive modifications of hypotheses after an interim analysis
    • Hommel G. Adaptive modifications of hypotheses after an interim analysis. Biometrical Journal 2001; 43:581-589.
    • (2001) Biometrical Journal , vol.43 , pp. 581-589
    • Hommel, G.1
  • 6
    • 54549113164 scopus 로고    scopus 로고
    • A group-sequential design for clinical trials with treatment selection
    • Stallard N, Friede T. A group-sequential design for clinical trials with treatment selection. Statistics in Medicine 2008; 27:6209-6227.
    • (2008) Statistics in Medicine , vol.27 , pp. 6209-6227
    • Stallard, N.1    Friede, T.2
  • 7
    • 0035977433 scopus 로고    scopus 로고
    • Modication of the sample size and the schedule of interim analyses in survival trials based on data inspections
    • Schäfer H, Müller H. Modication of the sample size and the schedule of interim analyses in survival trials based on data inspections. Statistics in Medicine 2001; 20:3741-3751.
    • (2001) Statistics in Medicine , vol.20 , pp. 3741-3751
    • Schäfer, H.1    Müller, H.2
  • 8
    • 0029589385 scopus 로고
    • Designed extension of studies based on conditional power
    • Proschan MA, Hunsberger S. 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.2
  • 9
    • 33748792968 scopus 로고    scopus 로고
    • Letter to be editor: modification of the sample size and the schedule of interim analyses in survival trials based on data inspections
    • Bauer P, Posch M. Letter to be editor: modification of the sample size and the schedule of interim analyses in survival trials based on data inspections. Statistics in Medicine 2004; 23:1333-1335.
    • (2004) Statistics in Medicine , vol.23 , pp. 1333-1335
    • Bauer, P.1    Posch, M.2
  • 10
    • 33748570462 scopus 로고    scopus 로고
    • Planning and analyzing adaptive group sequential survival trials
    • Wassmer G. Planning and analyzing adaptive group sequential survival trials. Biometrical Journal 2006; 48:714-729.
    • (2006) Biometrical Journal , vol.48 , pp. 714-729
    • Wassmer, G.1
  • 11
    • 79956157675 scopus 로고    scopus 로고
    • An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints
    • Jenkins M, Stone A, Jennison C. An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints. Pharmaceutical Statistics 2011; 10:347-356.
    • (2011) Pharmaceutical Statistics , vol.10 , pp. 347-356
    • Jenkins, M.1    Stone, A.2    Jennison, C.3
  • 13
    • 0009663357 scopus 로고
    • A multiple comparison procedure for comparing several treatments with a control
    • Dunnett CW. A multiple comparison procedure for comparing several treatments with a control. Journal of the American Statistical 1995; 50(272):1096-1121.
    • (1995) Journal of the American Statistical , vol.50 , Issue.272 , pp. 1096-1121
    • Dunnett, C.W.1
  • 14
    • 80055085677 scopus 로고    scopus 로고
    • Time-to-event analysis with treatment arm selection at interim
    • Di Scala L, Glimm E. Time-to-event analysis with treatment arm selection at interim. Statistics in Medicine 2011; 30:3067-3081.
    • (2011) Statistics in Medicine , vol.30 , pp. 3067-3081
    • Di Scala, L.1    Glimm, E.2
  • 15
    • 0017146303 scopus 로고
    • On closed testing procedures with special reference to ordered analysis of variance
    • Marcus R, Peritz E, Gabriel KR. On closed testing procedures with special reference to ordered analysis of variance. Biometrika 1976; 63:655-660.
    • (1976) Biometrika , vol.63 , pp. 655-660
    • Marcus, R.1    Peritz, E.2    Gabriel, K.R.3
  • 16
    • 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; 75:800-802.
    • (1988) Biometrika , vol.75 , pp. 800-802
    • Hochberg, Y.1
  • 18
    • 33644917731 scopus 로고    scopus 로고
    • Gatekeeping procedures in dose-response clinical trials based on the Dunnett test
    • Dmitrienko A, Offen W, Wang O, Xiao D. Gatekeeping procedures in dose-response clinical trials based on the Dunnett test. Pharmaceutical Statistics 2006; 5(1):19-28.
    • (2006) Pharmaceutical Statistics , vol.5 , Issue.1 , pp. 19-28
    • Dmitrienko, A.1    Offen, W.2    Wang, O.3    Xiao, D.4
  • 19
    • 0043136549 scopus 로고    scopus 로고
    • Gatekeeping strategies for clinical trials that do not require all primary effects to be signifficant
    • Dmitrienko A, Offen W, Westfall P. Gatekeeping strategies for clinical trials that do not require all primary effects to be signifficant. Statistics in Medicine 2003; 22:2387-2400.
    • (2003) Statistics in Medicine , vol.22 , pp. 2387-2400
    • Dmitrienko, A.1    Offen, W.2    Westfall, P.3
  • 20
    • 38249007218 scopus 로고
    • Two stage conditionally unbiased estimators of the selected mean
    • Cohen A, Sackrowitz HB. Two stage conditionally unbiased estimators of the selected mean. Statistics & Probability Letters 1989; 8:273-278.
    • (1989) Statistics & Probability Letters , vol.8 , pp. 273-278
    • Cohen, A.1    Sackrowitz, H.B.2
  • 21
    • 0035879557 scopus 로고    scopus 로고
    • An improved method of evaluationg drug effect in a multiple dose clinical trial
    • Shen L. An improved method of evaluationg drug effect in a multiple dose clinical trial. Statistics in Medicine 2001; 20:1913-1929.
    • (2001) Statistics in Medicine , vol.20 , pp. 1913-1929
    • Shen, L.1
  • 22
    • 18444383925 scopus 로고    scopus 로고
    • Point estimators and confidence regions for sequential trials involving selection
    • Stallard N, Todd S. Point estimators and confidence regions for sequential trials involving selection. Journal of Statistical Planning and Inference 2005; 135:402-419.
    • (2005) Journal of Statistical Planning and Inference , vol.135 , pp. 402-419
    • Stallard, N.1    Todd, S.2
  • 23
    • 54349104178 scopus 로고    scopus 로고
    • Unbiased estimation of selected treatment means in two-stage trials
    • Bowden J, Glimm E. Unbiased estimation of selected treatment means in two-stage trials. Biometrical Journal 2008; 4:515-527.
    • (2008) Biometrical Journal , vol.4 , pp. 515-527
    • Bowden, J.1    Glimm, E.2
  • 24
    • 84876448156 scopus 로고    scopus 로고
    • Shrinkage estimation in two-stage adaptive designs with midtrial treatment selection
    • Carreras M, Brannath W. Shrinkage estimation in two-stage adaptive designs with midtrial treatment selection. Statistics in Medicine 2013; 32(10):1677-1690.
    • (2013) Statistics in Medicine , vol.32 , Issue.10 , pp. 1677-1690
    • Carreras, M.1    Brannath, W.2
  • 25
    • 54549122408 scopus 로고    scopus 로고
    • Compatible simultaneous lower confidence bounds for the Holm procedure and other Bonferroni-based closed tests
    • Strassburger K, Bretz F. Compatible simultaneous lower confidence bounds for the Holm procedure and other Bonferroni-based closed tests. Statistics in Medicine 2008; 27:4914-4927.
    • (2008) Statistics in Medicine , vol.27 , pp. 4914-4927
    • Strassburger, K.1    Bretz, F.2
  • 26
    • 54549107976 scopus 로고    scopus 로고
    • Simultaneous Confidence Regions Corresponding to Holm's Step-Down Procedure and Other Closed-Testing Procedures
    • Guilbaud O. Simultaneous Confidence Regions Corresponding to Holm's Step-Down Procedure and Other Closed-Testing Procedures. Biometrical Journal 2008; 50:678-692.
    • (2008) Biometrical Journal , vol.50 , pp. 678-692
    • Guilbaud, O.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.