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Volumn 299, Issue 15, 2008, Pages 1813-1817

Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: A case study based on documents from rofecoxib litigation

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; ROFECOXIB; CYCLOOXYGENASE 2 INHIBITOR; LACTONE; SULFONE;

EID: 42249100174     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.299.15.1813     Document Type: Review
Times cited : (150)

References (25)
  • 1
    • 4544223937 scopus 로고    scopus 로고
    • Clinical trial registration: A statement from the International Committee of Medical Journal Editors
    • DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292(11):1363-1364.
    • (2004) JAMA , vol.292 , Issue.11 , pp. 1363-1364
    • DeAngelis, C.D.1    Drazen, J.M.2    Frizelle, F.A.3
  • 2
    • 42249113422 scopus 로고    scopus 로고
    • Food and Drug Administration Amendments Act of, Pub L, Accessed October 11, 2007
    • Food and Drug Administration Amendments Act of 2007. HR 3580, enacted by the House and Senate, Pub L No 110-85. http://frwebgate.access.gpo.gov/cgi-bin/ getdoc.cgi?dbname=110_cong_bills&docid=f:h3580enr.txt.pdf. Accessed October 11, 2007.
    • (2007) HR 3580, enacted by the House and Senate , Issue.110-185
  • 3
    • 33644792767 scopus 로고    scopus 로고
    • Reporting of noninferiority and equivalence randomized trials
    • Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SWJ. Reporting of noninferiority and equivalence randomized trials. JAMA. 2006;295(10):1152-1160.
    • (2006) JAMA , vol.295 , Issue.10 , pp. 1152-1160
    • Piaggio, G.1    Elbourne, D.R.2    Altman, D.G.3    Pocock, S.J.4    Evans, S.W.J.5
  • 4
    • 38049047590 scopus 로고    scopus 로고
    • Publication of clinical trials in JAMA: Information for authors
    • Fontanarosa PB, DeAngelis CD. Publication of clinical trials in JAMA: information for authors. JAMA. 2008;299:95-96.
    • (2008) JAMA , vol.299 , pp. 95-96
    • Fontanarosa, P.B.1    DeAngelis, C.D.2
  • 5
    • 38349049478 scopus 로고    scopus 로고
    • Selective publication of antidepressant trials and its influence on apparent efficacy
    • Turner EH, Matthews A, Linardatos E, Tell R, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252-260.
    • (2008) N Engl J Med , vol.358 , Issue.3 , pp. 252-260
    • Turner, E.H.1    Matthews, A.2    Linardatos, E.3    Tell, R.4    Rosenthal, R.5
  • 6
    • 42249098023 scopus 로고    scopus 로고
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County September 23, 2005
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County (September 23, 2005).
  • 7
    • 19744380776 scopus 로고    scopus 로고
    • APPROVe Trial Investigators. Cardiovascular events associated with rofecoxib in a 3-year randomized colorectal adenoma chemoprevention trial
    • Bresalier RS, Sandler RS, Quan H, et al; APPROVe Trial Investigators. Cardiovascular events associated with rofecoxib in a 3-year randomized colorectal adenoma chemoprevention trial. N Engl J Med. 2005;352(11):1092-1102.
    • (2005) N Engl J Med , vol.352 , Issue.11 , pp. 1092-1102
    • Bresalier, R.S.1    Sandler, R.S.2    Quan, H.3
  • 8
    • 34547148986 scopus 로고    scopus 로고
    • Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer
    • for the VICTOR Trial Group
    • Kerr DJ, Dunn J, Langman M, et al; for the VICTOR Trial Group. Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer. N Engl J Med. 2007;357(4):360-369.
    • (2007) N Engl J Med , vol.357 , Issue.4 , pp. 360-369
    • Kerr, D.J.1    Dunn, J.2    Langman, M.3
  • 9
    • 21144447586 scopus 로고    scopus 로고
    • Rofecoxib Protocol 078 Study Group. A randomized double-blind, study of rofecoxib in patients with mild cognitive impairment
    • Thal LJ, Ferris SH, Korby L; Rofecoxib Protocol 078 Study Group. A randomized double-blind, study of rofecoxib in patients with mild cognitive impairment. Neuropsychopharmacology. 2005;30(6):1204-1215.
    • (2005) Neuropsychopharmacology , vol.30 , Issue.6 , pp. 1204-1215
    • Thal, L.J.1    Ferris, S.H.2    Korby, L.3
  • 10
    • 0345830739 scopus 로고    scopus 로고
    • Rofecoxib: No effect on Alzheimer's disease in a 1-year, randomized, blinded, controlled study
    • Reines SA, Block GA, Morris JC, et al. Rofecoxib: no effect on Alzheimer's disease in a 1-year, randomized, blinded, controlled study. Neurology. 2004;62(1):66-71.
    • (2004) Neurology , vol.62 , Issue.1 , pp. 66-71
    • Reines, S.A.1    Block, G.A.2    Morris, J.C.3
  • 11
    • 42249101331 scopus 로고    scopus 로고
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County. Plaintiff Exhibit Pl.0023, MRK-01420145856 September 23, 2005, Safety Update Report
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County. Plaintiff Exhibit Pl.0023, MRK-01420145856 (September 23, 2005). Safety Update Report.
  • 12
    • 42249085028 scopus 로고    scopus 로고
    • Merck produced nonconfidential document. FDAWEB 000634, linked to MRK-AAF0005014.
    • Merck produced nonconfidential document. FDAWEB 000634, linked to MRK-AAF0005014.
  • 13
    • 42249098376 scopus 로고    scopus 로고
    • Merck produced nonconfidential document. MRK-01420167265.
    • Merck produced nonconfidential document. MRK-01420167265.
  • 14
    • 42249097372 scopus 로고    scopus 로고
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County. Plaintiff Exhibit Pl.0079, MRK-AAAX0000752 September 23, 2005
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County. Plaintiff Exhibit Pl.0079, MRK-AAAX0000752 (September 23, 2005).
  • 15
    • 42249088382 scopus 로고    scopus 로고
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County. Plaintiff Exhibit 362, MRK-NJ0186457 February 6, 2007
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County. Plaintiff Exhibit 362, MRK-NJ0186457 (February 6, 2007).
  • 16
    • 42249085540 scopus 로고    scopus 로고
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County. Defendant Exhibit D-1445, MRK-I8940079159 February 6, 2007, Clinical study report
    • Humeston et al v Merck & Company, Inc. Case #619 in Superior Court of New Jersey, Atlantic County. Defendant Exhibit D-1445, MRK-I8940079159 (February 6, 2007). Clinical study report.
  • 17
    • 42249103555 scopus 로고    scopus 로고
    • In Re: Vioxx litigation, case code 619, civil action (ATL-L-2272-03). Filed January 13, 2006, in Superior Court of New Jersey, Atlantic County.
    • In Re: Vioxx litigation, case code 619, civil action (ATL-L-2272-03). Filed January 13, 2006, in Superior Court of New Jersey, Atlantic County.
  • 18
    • 0035934070 scopus 로고    scopus 로고
    • Risk of cardiovascular events associated with selective COX-2 inhibitors
    • Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001;286(8):954-959.
    • (2001) JAMA , vol.286 , Issue.8 , pp. 954-959
    • Mukherjee, D.1    Nissen, S.E.2    Topol, E.J.3
  • 19
    • 0035818601 scopus 로고    scopus 로고
    • Cardiovascular thrombotic events in controlled clinical trials of rofecoxib
    • Konstam MA, Weir MR, Reicin A, et al. Cardiovascular thrombotic events in controlled clinical trials of rofecoxib. Circulation. 2001;104(19):2280-2288.
    • (2001) Circulation , vol.104 , Issue.19 , pp. 2280-2288
    • Konstam, M.A.1    Weir, M.R.2    Reicin, A.3
  • 20
    • 35548938130 scopus 로고    scopus 로고
    • Office of the Inspector General, Washington, DC: Dept of Health and Human Services; September, Accessed October 3, 2007
    • Office of the Inspector General. The Food and Drug Administration's oversight of clinical trials. Washington, DC: Dept of Health and Human Services; September 2007. http://oig.hhs.gov/oei/reports/oei-01-06-00160.pdf. Accessed October 3, 2007.
    • (2007) The Food and Drug Administration's oversight of clinical trials
  • 21
    • 20444493551 scopus 로고    scopus 로고
    • Is this clinical trial fully registered? a statement from the International Committee of Medical Journal Editors
    • DeAngelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? a statement from the International Committee of Medical Journal Editors. JAMA. 2005;293(23):2927-2929.
    • (2005) JAMA , vol.293 , Issue.23 , pp. 2927-2929
    • DeAngelis, C.D.1    Drazen, J.M.2    Frizelle, F.A.3
  • 22
    • 33845298076 scopus 로고    scopus 로고
    • Principles for strengthening the integrity of clinical research
    • doi:10.1371/journal. pctr.0010001
    • Korn D, Ehringhaus S. Principles for strengthening the integrity of clinical research. PLoS Clin Trials. 2006;1(1):e1. doi:10.1371/journal. pctr.0010001.
    • (2006) PLoS Clin Trials , vol.1 , Issue.1
    • Korn, D.1    Ehringhaus, S.2
  • 23
    • 34948861224 scopus 로고    scopus 로고
    • Commercializing clinical trials - risks and benefits of the CRO boom
    • Shuchman M. Commercializing clinical trials - risks and benefits of the CRO boom. N Engl J Med. 2007;357(14):1365-1368.
    • (2007) N Engl J Med , vol.357 , Issue.14 , pp. 1365-1368
    • Shuchman, M.1
  • 24
    • 42249100116 scopus 로고    scopus 로고
    • Grassley CE. Letter to FDA. United States Senate Committee on Finance with additional back up data. December 13, 2006.
    • Grassley CE. Letter to FDA. United States Senate Committee on Finance with additional back up data. December 13, 2006.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.