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Volumn 14, Issue 3, 2005, Pages 303-318

Multicentre trials: A US regulatory perspective

Author keywords

[No Author keywords available]

Indexed keywords

METOPROLOL SUCCINATE; NEW DRUG; PLACEBO;

EID: 20444401857     PISSN: 09622802     EISSN: None     Source Type: Journal    
DOI: 10.1191/0962280205sm398oa     Document Type: Review
Times cited : (36)

References (27)
  • 1
    • 0004278273 scopus 로고    scopus 로고
    • Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications
    • US Department of Health and Human Services Rockville, MD: US Department of Health and Human Services, Public Health Service, Food and Drug Administration, July 1988
    • US Department of Health and Human Services Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications. Rockville, MD: US Department of Health and Human Services, Public Health Service, Food and Drug Administration, July 1988.
  • 2
    • 0003716539 scopus 로고    scopus 로고
    • Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
    • US Department of Health and Human Services US Department of Health and Human Services, Food and Drug Administration, May
    • US Department of Health and Human Services Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. US Department of Health and Human Services, Food and Drug Administration, May 1998.
    • (1998)
  • 3
    • 0001184886 scopus 로고    scopus 로고
    • Draft Guideline on Statistical Principles for Clinical Trials
    • Food and Drug Administration International Conference on Harmonization
    • Food and Drug Administration International Conference on Harmonization: Draft Guideline on Statistical Principles for Clinical Trials. Federal Register 1997; 62(90): 25711-26.
    • (1997) Federal Register , vol.62 , Issue.90 , pp. 25711-25726
  • 4
    • 20444427369 scopus 로고    scopus 로고
    • Discussion of papers
    • Freeman P. Discussion of papers. Statistics in Medicine 1998; 17: 1799-1800.
    • (1998) Statistics in Medicine , vol.17 , pp. 1799-1800
    • Freeman, P.1
  • 5
    • 0000559926 scopus 로고
    • 'Designs, Methods and Baseline Characteristics'
    • The University Group Diabetes Program I
    • The University Group Diabetes Program I, 'Designs, Methods and Baseline Characteristics.' The Journal of the American Diabetes Association 1970; 19(S2): 747-830.
    • (1970) The Journal of the American Diabetes Association , vol.19 , Issue.S2 , pp. 747-830
  • 6
    • 20444390761 scopus 로고
    • The Coronary Drug Project
    • New York: American Heart Association
    • 'The Coronary Drug Project.' The American Heart Association Monograph, No. 38. New York: American Heart Association, 1973.
    • (1973) The American Heart Association Monograph , Issue.38
  • 7
    • 20444424704 scopus 로고
    • as amended. Washington, DC: US Government Printing Office, Chapter V
    • Federal Food, Drug, and Cosmetic Act, as amended. Washington, DC: US Government Printing Office, 1972: Chapter V, 35-57.
    • (1972) Federal Food, Drug, and Cosmetic Act , pp. 35-57
  • 8
    • 20444401687 scopus 로고    scopus 로고
    • Food and Drug Modernization Act
    • Food and Drug Modernization Act, 1998.
    • (1998)
  • 10
    • 0033618144 scopus 로고    scopus 로고
    • Selection bias and treatment heterogeneity in clinical trials
    • Longford NT. Selection bias and treatment heterogeneity in clinical trials. Statistics in Medicine 1999; 18: 1467-74.
    • (1999) Statistics in Medicine , vol.18 , pp. 1467-1474
    • Longford, N.T.1
  • 11
    • 0035643502 scopus 로고    scopus 로고
    • Understanding on the pooled test for controlled clinical trials
    • Lu L, Huque M. Understanding on the pooled test for controlled clinical trials. Biometrical Journal 2001; 43(7): 909-23.
    • (2001) Biometrical Journal , vol.43 , Issue.7 , pp. 909-923
    • Lu, L.1    Huque, M.2
  • 12
    • 0027034828 scopus 로고
    • Demonstration of the reproducibility of treatment efficacy from a single multicentre trial
    • Huster WJ, Louv WC. Demonstration of the reproducibility of treatment efficacy from a single multicentre trial. Journal of Biopharmaceutical Statistics 1992; 2: 2-1-238.
    • (1992) Journal of Biopharmaceutical Statistics , vol.2
    • Huster, W.J.1    Louv, W.C.2
  • 13
    • 0033004552 scopus 로고    scopus 로고
    • One large, well-designed multiple centre study as an alternative to the usual FDA paradigm
    • Fisher LD. One large, well-designed multiple centre study as an alternative to the usual FDA paradigm. Drug Information Journal 1999; 33: 265-27.
    • (1999) Drug Information Journal , vol.33 , pp. 227-265
    • Fisher, L.D.1
  • 16
    • 1542757331 scopus 로고    scopus 로고
    • Balancing the number and size of sites: An economic approach to the optimal design of cluster samples
    • Connelly L. Balancing the number and size of sites: an economic approach to the optimal design of cluster samples. Controlled Clinical Trials 2003; 24: 544-59.
    • (2003) Controlled Clinical Trials , vol.24 , pp. 544-559
    • Connelly, L.1
  • 18
    • 0043136523 scopus 로고    scopus 로고
    • Probability models and computational models for ANOVA in multicentre clinical trials
    • Permutt T. Probability models and computational models for ANOVA in multicentre clinical trials. Journal of Biopharmaceutical Statistics 2003; 13: 495-505.
    • (2003) Journal of Biopharmaceutical Statistics , vol.13 , pp. 495-505
    • Permutt, T.1
  • 19
    • 0032529143 scopus 로고    scopus 로고
    • Some controversies in planning and analyzing multicentre trials
    • Senn S. Some controversies in planning and analyzing multicentre trials. Statitics in Medicine 1998; 17: 1753-65.
    • (1998) Statitics in Medicine , vol.17 , pp. 1753-1765
    • Senn, S.1
  • 20
    • 0345320344 scopus 로고    scopus 로고
    • An issue of statistical analysis in controlled multicentre studies: How shall we weight the centres?
    • Lin Z. An issue of statistical analysis in controlled multicentre studies: how shall we weight the centres? Statistics in Medicine 1999; 18: 365-73.
    • (1999) Statistics in Medicine , vol.18 , pp. 365-373
    • Lin, Z.1
  • 21
    • 0022072706 scopus 로고
    • Testing for qualitative interactions between treatment effects and patient subsets
    • Gail M, Simon R. Testing for qualitative interactions between treatment effects and patient subsets. Biometrics 1985; 41: 361-72.
    • (1985) Biometrics , vol.41 , pp. 361-372
    • Gail, M.1    Simon, R.2
  • 22
    • 20444400968 scopus 로고    scopus 로고
    • Extreme treatment effects in multicentre trials
    • Unpublished manuscript
    • Tsong Y, O'Neill RT. Extreme treatment effects in multicentre trials. Unpublished manuscript.
    • Tsong, Y.1    O'Neill, R.T.2
  • 23
    • 20444362520 scopus 로고    scopus 로고
    • Good clinical practice: Consolidated guidance
    • International Conference on Harmonization E6. April
    • International Conference on Harmonization E6. Good clinical practice: consolidated guidance, April 1996.
    • (1996)
  • 24
    • 0032503314 scopus 로고    scopus 로고
    • Guidance on ethnic factors in the acceptability of foreign clinical data; Availability
    • Food and Drug Administration International Conference on Harmonization
    • Food and Drug Administration International Conference on Harmonization: Guidance on ethnic factors in the acceptability of foreign clinical data; Availability. Federal Register 1998; 63(111), 31790.
    • (1998) Federal Register , vol.63 , Issue.111 , pp. 31790
  • 25
    • 20444370053 scopus 로고    scopus 로고
    • Food and Drug Administration Guidance for Industry, Clinical studies section of labeling for prescription drugs and biologic - Content and format
    • Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, May
    • Food and Drug Administration Guidance for Industry, Clinical studies section of labeling for prescription drugs and biologic - content and format. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, May 2001.
    • (2001)
  • 26
    • 20444384898 scopus 로고
    • Guideline for industry: Studies in support of special populations: Geriatrics
    • International Conference on Harmonization E7. August
    • International Conference on Harmonization E7. Guideline for industry: studies in support of special populations: geriatrics, August 1994.
    • (1994)
  • 27
    • 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)
    • MERIT-HF Study Group
    • 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). MERIT-HF Study Group. The Journal of the American Medical Association 2000; 283(10): 1295-302.
    • (2000) The Journal of the American Medical Association , vol.283 , Issue.10 , pp. 1295-1302


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