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Volumn 44, Issue 5, 2010, Pages 617-632

Assessment of consistency of treatment effects in multiregional clinical trials

Author keywords

Ethnic effect; Interaction; Noninferiority; Power; Random effect model; Sample size

Indexed keywords

CLINICAL ASSESSMENT; CLINICAL TRIAL; MULTIREGIONAL CLINICAL TRIAL; PRIORITY JOURNAL; PROBABILITY; RANDOM SAMPLE; RESEARCH PRIORITY; REVIEW; SIMULATION; STUDY DESIGN; SURVIVAL; THERAPY EFFECT;

EID: 78650217349     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286151004400509     Document Type: Review
Times cited : (55)

References (14)
  • 1
    • 0011476837 scopus 로고    scopus 로고
    • International Conference on Harmonization Tripartite Guidance E5. Ethnic factor in the acceptability of foreign data
    • ICH.
    • ICH. International Conference on Harmonization Tripartite Guidance E5. Ethnic factor in the acceptability of foreign data. Federal Register, 1998;83:31790-31796.
    • (1998) Federal Register , vol.83 , pp. 31790-31796
  • 2
    • 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. Control Clin Trials. 2001;22:357-366.
    • (2001) Control Clin Trials , vol.22 , pp. 357-366
    • Shih, W.J.1
  • 4
    • 0036431676 scopus 로고    scopus 로고
    • Bridging studies in clinical development
    • Liu JP, Chow SC. Bridging studies in clinical development. J Biopharm Stat. 2002;12:359-367.
    • (2002) J Biopharm Stat , vol.12 , pp. 359-367
    • Liu, J.P.1    Chow, S.C.2
  • 5
    • 0141889798 scopus 로고    scopus 로고
    • A group sequential approach to evaluation of bridging studies
    • DOI 10.1081/BIP-120024210
    • Hsiao CF, Xu JZ, Liu JP. A group sequential approach to evaluation of bridging studies. J Biopharm Stat. 2003;13:793-801. (Pubitemid 37259718)
    • (2003) Journal of Biopharmaceutical Statistics , vol.13 , Issue.4 , pp. 793-801
    • Hsiao, C.-F.1    Xu, J.-Z.2    Liu, J.-P.3
  • 8
    • 77149171473 scopus 로고    scopus 로고
    • Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance
    • early view
    • 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. Pharm Stat. 2009; early view, http://www3.interscience.wiley.com/cgi- bin/fulltext/122432408/PDFSTART.
    • (2009) Pharm Stat
    • Quan, H.1    Zhao, P.L.2    Zhang, J.3    Roessner, M.4    Aizawa, K.5
  • 9
    • 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 Inf J. 2007;42:139-147.
    • (2007) Drug Inf J , vol.42 , pp. 139-147
    • Kawai, N.1    Chuang-Stein, C.2    Komiyama, O.3    Li, Y.4
  • 10
    • 77957370346 scopus 로고    scopus 로고
    • Assessment of consistency of treatment effects in multi-regional clinical trials
    • September
    • Quan H, Li M, Chen J, et al. Assessment of consistency of treatment effects in multi-regional clinical trials. Sanofi-Aventis Tech Report #034, September 2009.
    • (2009) Sanofi-Aventis Tech Report #034
    • Quan, H.1    Li, M.2    Chen, J.3
  • 11
    • 78650207131 scopus 로고    scopus 로고
    • Design considerations for bridging clinical trials and global clinical trials
    • Presented at
    • Hung HMJ. Design considerations for bridging clinical trials and global clinical trials. Presented at DIA Annual Meeting, Atlanta, GA, June 20, 2007.
    • DIA Annual Meeting, Atlanta, GA, June 20, 2007
    • Hung, H.M.J.1
  • 12
    • 0000549737 scopus 로고
    • The asymptotic properties of non-parametric tests for comparing survival distributions
    • Schoenfeld D. The asymptotic properties of non-parametric tests for comparing survival distributions. Biometrika. 1981;68:316-319.
    • (1981) Biometrika , vol.68 , pp. 316-319
    • Schoenfeld, D.1
  • 13
    • 0031591631 scopus 로고    scopus 로고
    • For qualitative interaction of clinical significance
    • DOI 10.1002/(SICI)1097-0258(19970730)16:14<1645::AID-SIM596>3.0. CO;2-G
    • Pan G, Wolfe DA. Test for qualitative interaction of clinical significance. Stat Med. 1997;16:1645-1652. (Pubitemid 27341619)
    • (1997) Statistics in Medicine , vol.16 , Issue.14 , pp. 1645-1652
    • Pan, G.1    Wolfe, D.A.2
  • 14
    • 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


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.