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Volumn 37, Issue 10, 2007, Pages 680-686

Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: How many patients die waiting?

Author keywords

Clinical trial; Medical ethics; Radiotherapy

Indexed keywords

ARTICLE; CANCER SURVIVAL; CANCER THERAPY; CONTROLLED STUDY; HEALTH SURVEY; HUMAN; MEDICAL ETHICS; MEDICAL RESEARCH; PRIORITY JOURNAL;

EID: 34748866535     PISSN: 14440903     EISSN: 14455994     Source Type: Journal    
DOI: 10.1111/j.1445-5994.2007.01451.x     Document Type: Article
Times cited : (29)

References (44)
  • 1
    • 13944270480 scopus 로고    scopus 로고
    • Australian Institute of Health and Welfare (AIHW), Australasian Association of Cancer Registries (AACR). Canberra, Australia: AIHW. AIHW Cat. No.: CAN 23 (Cancer Series no. 28) [cited 2005 Sep]. Available from URL:
    • Australian Institute of Health and Welfare (AIHW), Australasian Association of Cancer Registries (AACR). Cancer in Australia 2001. Canberra, Australia : AIHW 2004. AIHW Cat. No.: CAN 23 (Cancer Series no. 28) [cited 2005 Sep]. Available from URL : http://www.aihw.gov.au/publications/index.cfm/title/ 10083
    • (2004) Cancer in Australia 2001.
  • 2
    • 51549117737 scopus 로고    scopus 로고
    • Ries, L.A.G., Eisner, M.P., Kosary, C.L., Hankey, B.F., Miller, B.A., Clegg, L.*et al. eds). Bethesda: National Cancer Institute. 2005 [cited 2005 Sep]. Available from URL:
    • Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L et al eds). SEER Cancer Statistics Review, 1975-2002. Bethesda : National Cancer Institute 2005 [cited 2005 Sep]. Available from URL : http://seer.cancer.gov/csr/ 1975_2002/results_merged/sect_02_all_sites.pdf
    • SEER Cancer Statistics Review, 1975-2002.
  • 3
    • 1942454226 scopus 로고    scopus 로고
    • Sequential audits of unacceptable delays in radiation therapy in Australia and New Zealand
    • Faculty of Radiation Oncology, Royal Australasian College of Radiologists.
    • Kenny L, Lehman M Faculty of Radiation Oncology, Royal Australasian College of Radiologists. Sequential audits of unacceptable delays in radiation therapy in Australia and New Zealand. Australas Radiol 2004 48 : 29 34.
    • (2004) Australas Radiol , vol.48 , pp. 29-34
    • Kenny, L.1    Lehman, M.2
  • 5
    • 0037080091 scopus 로고    scopus 로고
    • Factors affecting workload of cancer clinical trials: Results of a multi-centre study of the national cancer institute of Canada clinical trials group
    • Roche K, Paul N, Smuck B, Whitehead M, Zee B, Pater J et al. Factors affecting workload of cancer clinical trials: results of a multi-centre study of the national cancer institute of Canada clinical trials group. J Clin Oncol 2002 20 : 545 56.
    • (2002) J Clin Oncol , vol.20 , pp. 545-56
    • Roche, K.1    Paul, N.2    Smuck, B.3    Whitehead, M.4    Zee, B.5    Pater, J.6
  • 6
    • 0032982208 scopus 로고    scopus 로고
    • Performance of research ethics committees in Spain. a prospective study of 100 applications for clinical trial protocols on medicines
    • Dal-Re R, Espada J, Ortega R. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines. J Med Ethics 1999 25 : 219 20.
    • (1999) J Med Ethics , vol.25 , pp. 219-20
    • Dal-Re, R.1    Espada, J.2    Ortega, R.3
  • 7
    • 0035990849 scopus 로고    scopus 로고
    • Oncologists' opinion of ethics commitees functioning in Italy [letter]
    • Apolone G, Mosconi P, Cattaneo G, Pomodoro L, Garattini S. Oncologists' opinion of ethics commitees functioning in Italy [letter]. Ann Oncol 2002 13 : 1157 60.
    • (2002) Ann Oncol , vol.13 , pp. 1157-60
    • Apolone, G.1    Mosconi, P.2    Cattaneo, G.3    Pomodoro, L.4    Garattini, S.5
  • 8
    • 16644380457 scopus 로고    scopus 로고
    • Multi-centre research: Negotiating the ethics approval obstacle course [letter]
    • Maxwell DJ, Kaye KI. Multi-centre research: negotiating the ethics approval obstacle course [letter]. Med J Aust 2004 181 : 460.
    • (2004) Med J Aust , vol.181 , pp. 460
    • Maxwell, D.J.1    Kaye, K.I.2
  • 9
    • 0842287389 scopus 로고    scopus 로고
    • Multi-centre research: Negotiating the ethics approval obstacle course
    • Roberts LM, Bowyer L, Homer CS, Brown MA. Multi-centre research: negotiating the ethics approval obstacle course. Med J Aust 2004 180 : 139.
    • (2004) Med J Aust , vol.180 , pp. 139
    • Roberts, L.M.1    Bowyer, L.2    Homer, C.S.3    Brown, M.A.4
  • 10
    • 0033521503 scopus 로고    scopus 로고
    • Are ethics committees retarding the improvement of health services in Australia
    • Jamrozik K, Kolybaba M. Are ethics committees retarding the improvement of health services in Australia. Med J Aust 1999 170 : 26 8.
    • (1999) Med J Aust , vol.170 , pp. 26-8
    • Jamrozik, K.1    Kolybaba, M.2
  • 11
    • 0033526702 scopus 로고    scopus 로고
    • We need a better system for multi-centre research [letter]
    • Bruinsma FJ, Venn AJ, Skene LLC. We need a better system for multi-centre research [letter]. Med J Aust 1999 171 : 52.
    • (1999) Med J Aust , vol.171 , pp. 52
    • Bruinsma, F.J.1    Venn, A.J.2    Skene, L.L.C.3
  • 13
    • 0032494078 scopus 로고    scopus 로고
    • Should there be an accredited ethics committee system for centralised review of multi-centre clinical research [letter]?
    • Henman MJ, Tattersall MHN, Brown RF. Should there be an accredited ethics committee system for centralised review of multi-centre clinical research [letter]? Med J Aust 1998 169 : 283 4.
    • (1998) Med J Aust , vol.169 , pp. 283-4
    • Henman, M.J.1    Tattersall, M.H.N.2    Brown, R.F.3
  • 14
    • 0035116519 scopus 로고    scopus 로고
    • Variability among institutional review board's decisions within the context of a multi-centre trial
    • Silverman H, Hull SC, Sugarman J. Variability among institutional review board's decisions within the context of a multi-centre trial. Crit Care Med 2001 29 : 235 41.
    • (2001) Crit Care Med , vol.29 , pp. 235-41
    • Silverman, H.1    Hull, S.C.2    Sugarman, J.3
  • 15
    • 0032494030 scopus 로고    scopus 로고
    • Should there be an accredited ethics committee system for centralised review of multi-centre clinical research? [letter]
    • O'Brien EA, Saltman DC, Berglund CA. Should there be an accredited ethics committee system for centralised review of multi-centre clinical research? [letter] Med J Aust 1998 169 : 284 5.
    • (1998) Med J Aust , vol.169 , pp. 284-5
    • O'Brien, E.A.1    Saltman, D.C.2    Berglund, C.A.3
  • 17
    • 85066551888 scopus 로고    scopus 로고
    • Australian research team takes on huge task
    • In: ed. Barton Australian Medical Association Ltd
    • Whiteman D. Australian research team takes on huge task. In : Flannery J, ed. Australian Medicine. Barton Australian Medical Association Ltd 2002.
    • (2002) Australian Medicine.
    • Whiteman, D.1    Flannery, J.2
  • 18
    • 0033526685 scopus 로고    scopus 로고
    • Outdated ethical review system impedes important research [letter]
    • Lowenthal RM. Outdated ethical review system impedes important research [letter]. Med J Aust 1999 171 : 51.
    • (1999) Med J Aust , vol.171 , pp. 51
    • Lowenthal, R.M.1
  • 20
    • 0033526718 scopus 로고    scopus 로고
    • New national guidelines for ethics committees are on the way [letter]
    • Chalmers D. New national guidelines for ethics committees are on the way [letter]. Med J Aust 1999 171 : 53.
    • (1999) Med J Aust , vol.171 , pp. 53
    • Chalmers, D.1
  • 21
    • 0003568394 scopus 로고    scopus 로고
    • National Health and Medical Research Council. [cited 2005 Sep and Dec]. Available from URL:
    • National Health and Medical Research Council. National statement on ethical conduct in research. 1999 [cited 2005 Sep and Dec]. Available from URL : http://www.nhmrc.gov.au/publications/synopses/e35syn.htm
    • (1999) National Statement on Ethical Conduct in Research
  • 22
    • 0003802728 scopus 로고    scopus 로고
    • World Medical Association Declaration of Helsinki. [cited 2005 Sep]. Available from URL:
    • World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects [cited 2005 Sep]. Available from URL : http://www.wma.net/e/policy/b3.htm
    • Ethical Principles for Medical Research Involving Human Subjects
  • 23
    • 0003419289 scopus 로고    scopus 로고
    • Therapeutic Goods Administration. [cited 2005 Sep]. Available from URL:
    • Therapeutic Goods Administration. Note for guidance on good clinical practice [cited 2005 Sep]. Available from URL : http://www.tga.gov.au/docs/html/ ich13595.htm
    • Note for Guidance on Good Clinical Practice
  • 25
    • 85066554512 scopus 로고    scopus 로고
    • Multicentre research: Negotiating the ethics approval obstacle course [letter]
    • Dickson HG. Multicentre research: negotiating the ethics approval obstacle course [letter]. Med J Aust 2004 181 : 459 60.
    • (2004) Med J Aust , vol.181 , pp. 459-60
    • Dickson, H.G.1
  • 26
    • 16644380457 scopus 로고    scopus 로고
    • Multicentre research: Negotiating the ethics approval obstacle course [letter]
    • Breen KJ. Multicentre research: negotiating the ethics approval obstacle course [letter]. Med J Aust 2004 181 8 460.
    • (2004) Med J Aust , vol.181 , Issue.8 , pp. 460
    • Breen, K.J.1
  • 27
    • 18144453811 scopus 로고    scopus 로고
    • Should there be an accredited ethics committee system for centralised review of multi-centre clinical research [letter]?
    • Gandevia SC, McKeown T, Wright MM, Briody GP, Watson JDG. Should there be an accredited ethics committee system for centralised review of multi-centre clinical research [letter]? Med J Aust 1998 169 : 285.
    • (1998) Med J Aust , vol.169 , pp. 285
    • Gandevia, S.C.1    McKeown, T.2    Wright, M.M.3    Briody, G.P.4    Watson, J.D.G.5
  • 28
    • 0142030976 scopus 로고    scopus 로고
    • Ethics committees and guardianship legislation [letter]
    • Fielding JE, Kelly H. Ethics committees and guardianship legislation [letter]. Med J Aust 2003 179 : 390.
    • (2003) Med J Aust , vol.179 , pp. 390
    • Fielding, J.E.1    Kelly, H.2
  • 30
    • 0032536505 scopus 로고    scopus 로고
    • Should there be an accredited ethics committee system for centralised review of multi-centre clinical research?
    • Beran RG. Should there be an accredited ethics committee system for centralised review of multi-centre clinical research? Med J Aust 1998 168 : 174 6.
    • (1998) Med J Aust , vol.168 , pp. 174-6
    • Beran, R.G.1
  • 31
    • 0032494078 scopus 로고    scopus 로고
    • Should there be an accredited ethics committee system for centralised review of multi-centre clinical research [letter]?
    • Clarke CW. Should there be an accredited ethics committee system for centralised review of multi-centre clinical research [letter]? Med J Aust 1998 169 : 283.
    • (1998) Med J Aust , vol.169 , pp. 283
    • Clarke, C.W.1
  • 33
    • 7044241407 scopus 로고    scopus 로고
    • Research ethics committees: What is their contribution?
    • Loff B, Black J. Research ethics committees: what is their contribution? Med J Aust 2004 181 : 440 41.
    • (2004) Med J Aust , vol.181 , pp. 440-41
    • Loff, B.1    Black, J.2
  • 34
    • 0033521496 scopus 로고    scopus 로고
    • Ethics committees: Is reform in order?
    • Loblay RH, Chalmers DRC. Ethics committees: is reform in order? Med J Aust 1999 170 : 9 10.
    • (1999) Med J Aust , vol.170 , pp. 9-10
    • Loblay, R.H.1    Chalmers, D.R.C.2
  • 35
    • 16644380457 scopus 로고    scopus 로고
    • Multicentre research: Negotiating the ethics approval obstacle course [letter]
    • Van Der Weyden MB. Multicentre research: negotiating the ethics approval obstacle course [letter]. Med J Aust 2004 181 : 460 61.
    • (2004) Med J Aust , vol.181 , pp. 460-61
    • Van Der Weyden, M.B.1
  • 37
    • 0033526824 scopus 로고    scopus 로고
    • The realities of ethical review of research in Australia
    • Pearn JH. The realities of ethical review of research in Australia. Med J Aust 1999 171 : 38 9.
    • (1999) Med J Aust , vol.171 , pp. 38-9
    • Pearn, J.H.1
  • 38
    • 0142260958 scopus 로고    scopus 로고
    • Adverse event reporting in clinical trials: Room for improvement
    • Liauw WS, Day RO. Adverse event reporting in clinical trials: room for improvement. Med J Aust 2003 179 : 426 8.
    • (2003) Med J Aust , vol.179 , pp. 426-8
    • Liauw, W.S.1    Day, R.O.2
  • 39
    • 85066542177 scopus 로고    scopus 로고
    • The Royal Australian College of General Practitioners. [cited 2005 Sep]. Available from URL:
    • The Royal Australian College of General Practitioners. Guidelines for National Committee Submissions [cited 2005 Sep]. Available from URL : http://www.racgp.org.au/document.asp%3Fid%20%3D%20523
    • Guidelines for National Committee Submissions
  • 40
    • 18744402782 scopus 로고    scopus 로고
    • Improving the governance of health research
    • Walsh MK, McNeil JJ, Breen KJ. Improving the governance of health research. Med J Aust 2005 182 : 468 71.
    • (2005) Med J Aust , vol.182 , pp. 468-71
    • Walsh, M.K.1    McNeil, J.J.2    Breen, K.J.3
  • 42
    • 34748874721 scopus 로고    scopus 로고
    • Research ethics committees: What can we learn from the Western European and United States experience?
    • Frew R. Research ethics committees: what can we learn from the Western European and United States experience? Monash Bioeth Rev 2002 20 : 61 77.
    • (2002) Monash Bioeth Rev , vol.20 , pp. 61-77
    • Frew, R.1
  • 43
    • 85066594659 scopus 로고    scopus 로고
    • New Zealand Health and Disability Ethics Committees. Multi-region ethics committee. Ministry of Health, New Zealand Government. [cited 2005 Sep]. Available from URL:
    • New Zealand Health and Disability Ethics Committees. Multi-region ethics committee. Ministry of Health, New Zealand Government [cited 2005 Sep]. Available from URL : http://www.newhealth.govt.nz/ethicscommittees/committees/ multi-region.htm
  • 44
    • 85066585236 scopus 로고    scopus 로고
    • New South Wales Health. [cited 2007 Apr). Available from URL:
    • New South Wales Health. Research Ethics - Shared Scientific Assessment Scheme [cited 2007 Apr). Available from URL : http://www.health.nsw.gov.au/ healthethics/ssas.html
    • Research Ethics - Shared Scientific Assessment Scheme


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.