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Volumn 9, Issue 3, 2010, Pages 242-253

Assessing consistent treatment effect in a multi-regional clinical trial: A systematic review

Author keywords

Consistency; Heterogeneity; Multi regional clinical trial; Qualitative; Quantitative

Indexed keywords

CLINICAL TRIAL; DRUG INDUSTRY; MULTIVARIATE ANALYSIS; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; REVIEW; UNITED STATES;

EID: 77957343984     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.438     Document Type: Review
Times cited : (54)

References (31)
  • 4
    • 0032054651 scopus 로고    scopus 로고
    • Do certain countries produce only positive results? A systematic review of controlled trials
    • Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials. Controlled Clinical Trials 1998; 19:159-166.
    • (1998) Controlled Clinical Trials , vol.19 , pp. 159-166
    • Vickers, A.1    Goyal, N.2    Harland, R.3    Rees, R.4
  • 5
    • 0011476837 scopus 로고    scopus 로고
    • ICH International Conference on Harmonization Tripartite Guidance E5: Ethnic Factor in the Acceptability of Foreign Data
    • ICH International Conference on Harmonization Tripartite Guidance E5: Ethnic Factor in the Acceptability of Foreign Data. The US Federal Register 1998; 83:31790-31796.
    • (1998) The US Federal Register , vol.83 , pp. 31790-31796
  • 6
    • 0035651983 scopus 로고    scopus 로고
    • Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: The HERO-2 randomised trial
    • The Hirulog and Early Reperfusion or Occlusion (HERO)-2 Trial Investigators
    • The Hirulog and Early Reperfusion or Occlusion (HERO)-2 Trial Investigators. Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: the HERO-2 randomised trial. Lancet 2001; 358:1855-1863.
    • (2001) Lancet , vol.358 , pp. 1855-1863
  • 7
    • 55049127403 scopus 로고    scopus 로고
    • Continental differences in clinical characteristics, management, and outcomes in patients hospitalized with worsening heart failure
    • for the EVEREST Investigators
    • Blair JEA, Zannad F, Konstam MA et al., for the EVEREST Investigators. Continental differences in clinical characteristics, management, and outcomes in patients hospitalized with worsening heart failure. Journal of the American College of Cardiology 2008; 52:1640-1648.
    • (2008) Journal of the American College of Cardiology , vol.52 , pp. 1640-1648
    • Blair, J.E.A.1    Zannad, F.2    Konstam, M.A.3
  • 8
    • 0033981265 scopus 로고    scopus 로고
    • For the PURSUIT Investigators. Geographic variability in outcomes within an international trial of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes
    • Akkerhuis KM, Deckers JW, Boersma E et al. for the PURSUIT Investigators. Geographic variability in outcomes within an international trial of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes. European Heart Journal 2000; 21:371-381.
    • (2000) European Heart Journal , vol.21 , pp. 371-381
    • Akkerhuis, K.M.1    Deckers, J.W.2    Boersma, E.3
  • 9
    • 17944379905 scopus 로고    scopus 로고
    • Challenges of subgroup analyses in multinational clinical trials: Experiences from the MERIT-HF trial
    • Wedel H, DeMets D, Deedwania P et al. Challenges of subgroup analyses in multinational clinical trials: experiences from the MERIT-HF trial. American Heart Journal 2001; 142:502-511.
    • (2001) American Heart Journal , vol.142 , pp. 502-511
    • Wedel, H.1    DeMets, D.2    Deedwania, P.3
  • 10
    • 51049124249 scopus 로고    scopus 로고
    • An approach to rationalize partitioning sample size into individual regions in a multiregional trial
    • Kawai N et al. An approach to rationalize partitioning sample size into individual regions in a multiregional trial. Drug Information Journal 2008; 42:139-147.
    • (2008) Drug Information Journal , vol.42 , pp. 139-147
    • Kawai, N.1
  • 11
    • 77954634717 scopus 로고    scopus 로고
    • Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance
    • DOI: 10.1002/pst.380
    • Quan H, Zhao PL, Zhang J et al. Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance. Pharmaceutical Statistics, DOI: 10.1002/pst.380.
    • Pharmaceutical Statistics
    • Quan, H.1    Zhao, P.L.2    Zhang, J.3
  • 12
    • 70449640199 scopus 로고    scopus 로고
    • Sample size allocation to regions in a multiregional trial
    • Uesaka H. Sample size allocation to regions in a multiregional trial. Journal of Biopharmaceutical Statistics 2009; 19:580-594.
    • (2009) Journal of Biopharmaceutical Statistics , vol.19 , pp. 580-594
    • Uesaka, H.1
  • 13
    • 0034104565 scopus 로고    scopus 로고
    • Effects of controlled release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: The Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF)
    • Hjalmarson A, Goldstein S, Fagerberg B et al. Effects of controlled release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF). JAMA 2000; 283:1295-1302.
    • (2000) JAMA , vol.283 , pp. 1295-1302
    • Hjalmarson, A.1    Goldstein, S.2    Fagerberg, B.3
  • 14
    • 41049093347 scopus 로고
    • The combination of estimates from different experiments
    • Cochran WG. The combination of estimates from different experiments. Biometrics 1954; 10:101-129.
    • (1954) Biometrics , vol.10 , pp. 101-129
    • Cochran, W.G.1
  • 18
    • 0023025908 scopus 로고
    • Analysis of data from multiclinic trials
    • Fleiss. Analysis of data from multiclinic trials. Controlled Clinical Trials 1986; 7:267-275.
    • (1986) Controlled Clinical Trials , vol.7 , pp. 267-275
    • Fleiss1
  • 19
    • 0034949104 scopus 로고    scopus 로고
    • Statistical issues relating to international differences in clinical trials
    • O'Shea JC, DeMets DL. Statistical issues relating to international differences in clinical trials. American Heart Journal 2001; 142:21-28.
    • (2001) American Heart Journal , vol.142 , pp. 21-28
    • O'Shea, J.C.1    DeMets, D.L.2
  • 20
    • 0008926519 scopus 로고    scopus 로고
    • Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes
    • The PURSUIT Trial Investigators
    • The PURSUIT Trial Investigators. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. New England Journal of Medicine 1998; 339: 436-443.
    • (1998) New England Journal of Medicine , vol.339 , pp. 436-443
  • 21
    • 0022072706 scopus 로고
    • Testing for qualitative interaction between treatment effects and patient subsets
    • Gail M, Simon R. Testing for qualitative interaction between treatment effects and patient subsets. Biometrics 1985; 41:361-372.
    • (1985) Biometrics , vol.41 , pp. 361-372
    • Gail, M.1    Simon, R.2
  • 22
    • 0027198279 scopus 로고
    • A comparison of the power of two tests for qualitative interactions
    • Piantadosi S, Gail M. A comparison of the power of two tests for qualitative interactions. Statistics in Medicine 1993; 12:1239-1248.
    • (1993) Statistics in Medicine , vol.12 , pp. 1239-1248
    • Piantadosi, S.1    Gail, M.2
  • 23
    • 0027319114 scopus 로고
    • Tests for qualitative treatment-by-centre interaction using a 'Pushback' procedure
    • Ciminera JL, Heyse JF, Nguyen HH, Tukey JW. Tests for qualitative treatment-by-centre interaction using a 'Pushback' procedure. Statistics in Medicine 1993; 12:1033-1045.
    • (1993) Statistics in Medicine , vol.12 , pp. 1033-1045
    • Ciminera, J.L.1    Heyse, J.F.2    Nguyen, H.H.3    Tukey, J.W.4
  • 24
    • 33646240626 scopus 로고    scopus 로고
    • Testing for crossover of two hazard functions using Gail and Simon's method
    • Chen YHJ, Liu GHF. Testing for crossover of two hazard functions using Gail and Simon's method. Journal of Biopharmaceutical Statistics 2006; 16: 313-326.
    • (2006) Journal of Biopharmaceutical Statistics , vol.16 , pp. 313-326
    • Chen, Y.H.J.1    Liu, G.H.F.2
  • 27
    • 77957370346 scopus 로고    scopus 로고
    • Assessment of consistency of treatment effects in multi-regional clinical trials
    • for the Consistency Workstream of the PhRMA MRCT Key Issue Team September
    • Quan H, Li M, Chen J et al. for the Consistency Workstream of the PhRMA MRCT Key Issue Team. Assessment of consistency of treatment effects in multi-regional clinical trials. Sanofi-Aventis Technical Report 034, September 2009.
    • (2009) Sanofi-Aventis Technical Report 034
    • Quan, H.1    Li, M.2    Chen, J.3
  • 28
    • 0036931168 scopus 로고    scopus 로고
    • Sample size requirements for evaluation of bridging evidence
    • Liu JP, Hsueh H, Chen J. Sample size requirements for evaluation of bridging evidence. Biometrical Journal 2002; 44:969-981.
    • (2002) Biometrical Journal , vol.44 , pp. 969-981
    • Liu, J.P.1    Hsueh, H.2    Chen, J.3
  • 29
    • 77957360399 scopus 로고    scopus 로고
    • NDA 20-386/SE1-028, March Available at
    • FDA Medical Review of COZAARTM Tablets (Losartan Potassium). NDA 20-386/SE1-028, March 2002. Available at http://www.fda.gov/ohrms/dockets/ac/02/ briefing/3849b1-03-medicalreview.pdf.
    • (2002) FDA Medical Review of COZAARTM Tablets (Losartan Potassium)
  • 31
    • 0037108235 scopus 로고    scopus 로고
    • Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: Current practice and problems
    • Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Statistics in Medicine 2002; 21:2917-2930.
    • (2002) Statistics in Medicine , vol.21 , pp. 2917-2930
    • Pocock, S.J.1    Assmann, S.E.2    Enos, L.E.3    Kasten, L.E.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.