메뉴 건너뛰기




Volumn 32, Issue 10, 2013, Pages 1691-1706

Empirical shrinkage estimator for consistency assessment of treatment effects in multi-regional clinical trials

Author keywords

Random effect model; Sample size; Type I error rate; Weighted estimator

Indexed keywords

ACCURACY; ALGORITHM; ARTICLE; BAYES THEOREM; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; EMPIRICAL SHRINKAGE ESTIMATOR; HUMAN; INTERNAL CONSISTENCY; MATHEMATICAL MODEL; MULTICENTER STUDY (TOPIC); NORMAL DISTRIBUTION; PROBABILITY; RANDOM ERROR; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; STUDY DESIGN; TREATMENT OUTCOME;

EID: 84876454031     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5543     Document Type: Article
Times cited : (46)

References (28)
  • 1
    • 0011476837 scopus 로고    scopus 로고
    • Ethnic factor in the acceptability of foreign data
    • The US Federal Register. (Available at:) [Accessed date: July 17, 2012].
    • The US Federal Register. Ethnic factor in the acceptability of foreign data. International Conference on Harmonisation; Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data; Federal Register 1998; 63:31790-31796. (Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073117.pdf) [Accessed date: July 17, 2012].
    • (1998) International Conference on Harmonisation; Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data; Federal Register , vol.63 , pp. 31790-31796
  • 2
    • 16644391425 scopus 로고    scopus 로고
    • Added values: controversies concerning randomization and additivity in clinical trials
    • Senn SJ.Added values: controversies concerning randomization and additivity in clinical trials. Statistics in Medicine 2004; 23(24):3729-3753.
    • (2004) Statistics in Medicine , vol.23 , Issue.24 , pp. 3729-3753
    • Senn, S.J.1
  • 3
    • 0034882176 scopus 로고    scopus 로고
    • Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective
    • Shih WJ.Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective. Controlled Clinical Trials 2001; 22:357-366.
    • (2001) Controlled Clinical Trials , vol.22 , pp. 357-366
    • Shih, W.J.1
  • 4
    • 84876429571 scopus 로고    scopus 로고
    • From bridging studies to global trial development. FDA-Industry Statistics Workshop, Washington DC, September 29, Available at:[Accessed date: July 17, 2012].
    • Shih WJ.From bridging studies to global trial development. FDA-Industry Statistics Workshop, Washington DC, September 29, 2006. (Available at: http://www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=2006presentations) [Accessed date: July 17, 2012].
    • (2006)
    • Shih, W.J.1
  • 5
    • 84876447567 scopus 로고    scopus 로고
    • Ministry of Health LaWoJ. Basic Concepts for Joint International Clinical Trials. September 28, 2007.
    • Ministry of Health LaWoJ. Basic Concepts for Joint International Clinical Trials. September 28, 2007.
  • 6
    • 84876429916 scopus 로고    scopus 로고
    • European Medicines Agency. Reflection paper on the extrapolation of results from clinical studies conducted outside Europe to the EU-population (draft). EMEA Doc. Ref. CHMP/EWP/692702/2008. February 2009. (Available at:) [Accessed date: July 17, 2012].
    • European Medicines Agency. Reflection paper on the extrapolation of results from clinical studies conducted outside Europe to the EU-population (draft). EMEA Doc. Ref. CHMP/EWP/692702/2008. February 2009. (Available at: http://www.emea.europa.eu/pdfs/human/ewp/69270208en.pdf) [Accessed date: July 17, 2012].
  • 7
    • 51049124249 scopus 로고    scopus 로고
    • An approach to rationalize partitioning sample size into individual regions in a multiregional trial
    • Kawai N, Chuang-Stein C, Komiyama O, Li Y.An approach to rationalize partitioning sample size into individual regions in a multiregional trial. Drug Information Journal 2007; 42:139-147.
    • (2007) Drug Information Journal , vol.42 , pp. 139-147
    • Kawai, N.1    Chuang-Stein, C.2    Komiyama, O.3    Li, Y.4
  • 8
    • 77954634717 scopus 로고    scopus 로고
    • Sample size considerations for Japanese patients in a multi-regional trial based on MHLW Guidance
    • Quan H, Zhao PL, Zhang J, Roessner M, Aizawa K.Sample size considerations for Japanese patients in a multi-regional trial based on MHLW Guidance. Pharmaceutical Statistics 2010; 9:100-112.
    • (2010) Pharmaceutical Statistics , vol.9 , pp. 100-112
    • Quan, H.1    Zhao, P.L.2    Zhang, J.3    Roessner, M.4    Aizawa, K.5
  • 11
    • 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
  • 14
    • 0033818505 scopus 로고    scopus 로고
    • Center-weighting issues in multicenter clinical trials
    • Gallo P.Center-weighting issues in multicenter clinical trials. Journal of Biopharmaceutical Statistics 2001; 10:145-163.
    • (2001) Journal of Biopharmaceutical Statistics , vol.10 , pp. 145-163
    • Gallo, P.1
  • 15
    • 0032528888 scopus 로고    scopus 로고
    • A comparison of various estimators of a treatment difference for a multi-centre clinical trial
    • Jones B, Teather D, Wang J, Lewis JA.A comparison of various estimators of a treatment difference for a multi-centre clinical trial. Statistics in Medicine 1998; 17:1767-77.
    • (1998) Statistics in Medicine , vol.17 , pp. 1767-1777
    • Jones, B.1    Teather, D.2    Wang, J.3    Lewis, J.A.4
  • 17
  • 18
    • 0032529143 scopus 로고    scopus 로고
    • Some controversies in planning and analysing multi-centre trials
    • Senn SJ.Some controversies in planning and analysing multi-centre trials. Statistics in Medicine 1998; 17:1753-1765.
    • (1998) Statistics in Medicine , vol.17 , pp. 1753-1765
    • Senn, S.J.1
  • 19
    • 77957340034 scopus 로고    scopus 로고
    • Consideration of regional difference in design and analysis of multi-regional trials
    • Hung HMJ, Wang SJ, O'Neill RT.Consideration of regional difference in design and analysis of multi-regional trials. Pharmaceutical Statistics 2010; 9:173-178.
    • (2010) Pharmaceutical Statistics , vol.9 , pp. 173-178
    • Hung, H.M.J.1    Wang, S.J.2    O'Neill, R.T.3
  • 21
    • 33846447795 scopus 로고    scopus 로고
    • The probability of observing negative subgroup results when the treatment effect is positive and homogenous across all subgroups
    • Li Z, Chuang-Stein C, Hoseyni C.The probability of observing negative subgroup results when the treatment effect is positive and homogenous across all subgroups. Drug information Journal 2007; 41:47-56.
    • (2007) Drug information Journal , vol.41 , pp. 47-56
    • Li, Z.1    Chuang-Stein, C.2    Hoseyni, C.3
  • 22
    • 75149119685 scopus 로고    scopus 로고
    • A Bayesian approach to evaluating regional treatment effect in a multiregional trial
    • Chen YH, Wu YC, Wang M.A Bayesian approach to evaluating regional treatment effect in a multiregional trial. Journal of Biopharmaceutical Statistics 2009; 19:900-915.
    • (2009) Journal of Biopharmaceutical Statistics , vol.19 , pp. 900-915
    • Chen, Y.H.1    Wu, Y.C.2    Wang, M.3
  • 23
    • 17144407928 scopus 로고    scopus 로고
    • Country specific cost comparisons from multinational clinical trials using empirical Bayesian shrinkage estimation: the Canadian ASSENT-3 economic analysis
    • Willan AR, Pinto EM, O'Brien BJ, Kaul P, Goeree R, Lynd L, Armstrong PW.Country specific cost comparisons from multinational clinical trials using empirical Bayesian shrinkage estimation: the Canadian ASSENT-3 economic analysis. Health Economics 2005; 14:327-338.
    • (2005) Health Economics , vol.14 , pp. 327-338
    • Willan, A.R.1    Pinto, E.M.2    O'Brien, B.J.3    Kaul, P.4    Goeree, R.5    Lynd, L.6    Armstrong, P.W.7
  • 24
    • 21244475080 scopus 로고    scopus 로고
    • Cost-effectiveness analysis for multinational clinical trials
    • Pinto EM, Willan AR, O'Brien BJ.Cost-effectiveness analysis for multinational clinical trials. Statistics in Medicine 2005; 24:1965-1982.
    • (2005) Statistics in Medicine , vol.24 , pp. 1965-1982
    • Pinto, E.M.1    Willan, A.R.2    O'Brien, B.J.3
  • 25
    • 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
  • 26
  • 27
    • 0033549290 scopus 로고    scopus 로고
    • Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF)
    • MERIT-HF Study Group.
    • MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). The Lancet 1999; 353:2001-2007.
    • (1999) The Lancet , vol.353 , pp. 2001-2007


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.